Clinical trial register · European Union · CTIS

EU Clinical Trials Tracker

Name: EU clinical trials authorised under CTIS
Creator: Priya Life Science
License: https://www.ema.europa.eu/en/about-us/legal-notice

The most recently authorised trials on the EU Clinical Trials Information System (CTIS), the single register for every trial run under the EU Clinical Trials Regulation (536/2014). CTIS holds a far larger historical archive than any one list can usefully show — this register states both numbers rather than picking one.

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Source: EMA Clinical Trials Information System (CTIS). Showing the 2557 most recently authorised of 12788 total CTIS records — a stated recency window, not the full historical archive. Synced 07 Nov 2026, 03:17 UTC

2557

Shown in this register

most recently authorised

12,788

Total on CTIS

full historical archive

789

Phase III

within the shown window

Top member states

Spain 1074 France 933 Germany 893 Italy 777 Poland 614 Netherlands 544

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All 28 states

Trials in this register

Phase

Study

Lead sponsor

Area

Member states

Decision

Phase I/II

A Long-term Follow-up Study in Male Participants with X-linked Myotubular Myopathy Treated with ASP2957

2025-524467-21-00X-linked myotubular myopathy

DrugASP2957

Astellas Gene Therapies Inc.

Musculoskeletal Diseases

France

06/11/2026

Phase I/II

PHASE I/IIa CLINICAL TRIAL FOR THE TREATMENT OF GRAFT VERSUS HOST DISEASE WITH A NEW GENERATION OF MESENCHYMAL STROMAL CELLS ECTOPICALLY EXPRESSING CXCR4 AND IL-10 IN STEROID-REFRACTORY AND INTOLERANT OR RUXOLITINIB-REFRACTORY PATIENTS

2025-523139-21-01Patients who have developed acute GVHD refractory to cortic…

Fundacion Instituto De Investigacion Sanitaria De Navarra

Immune System Diseases

Spain

04/11/2026

Phase I/II

Phase 1/2 study to evaluate the safety, pharmacokinetics, and preliminary efficacy of SAR447998 in adults with refractory Systemic Lupus Erythematosus or Rheumatoid Arthritis

2026-526117-28-00Systemic lupus erythematosus / Rheumatoid arthritis

Sanofi-Aventis Recherche & Developpement

Musculoskeletal Diseases

France

30/10/2026

Phase I/II

Phase 1/2 Open-Label Study with Extended Follow-Up to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Doses of ALN-6457 in Participants with Symptomatic Prion Disease

2026-526727-21-00Prion Disease

Regeneron Pharmaceuticals Inc.

Nervous System Diseases

Belgium

29/10/2026

Phase I/II

A Phase I/II multicenter, randomized, double-blind, dose-selecting trial to investigate the immunogenicity, reactogenicity and safety of an intradermally administered zoonotic influenza vaccine targeting H5N8 in different doses compared with intramuscular administration of the same vaccine in adults aged 40 to 80 years

2026-525756-28-00Avian Influenza

University Of Antwerp

Virus Diseases

Belgium, Netherlands, France, Germany

29/10/2026

Phase I/II

Intramuscular Epinephrine and Phentolamine in Healthy Adults – A Phase I-II Trial

2026-528313-12-00Healthy adults

Aarhus Universitet

Cardiovascular Diseases

Denmark

29/10/2026

Phase I/II

ORION-1: A phase 1/2, first-in-human study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of AVZO-023 as a single agent, and in combination with AVZO-021 and/or endocrine therapy in patients with advanced solid tumors

2026-525948-15-00Advanced Cancer

DrugsAVZO-021·Letrozole·Fulvestrant

Avenzo Therapeutics Inc.

Neoplasms

Spain, France, Germany, Belgium

28/10/2026

Phase I/II

A Phase I/II Open-Label Extension of Study TIGEM1-MPSVI, Evaluating the Safety and Efficacy of FT005, an Adeno-Associated Viral Vector 8 to Deliver the Human ARSB Gene to the Liver of Subjects with Mucopolysaccharidosis type VI (MPS VI)

2026-525847-34-00Mucopolysaccharidosis type VI (MPS VI)

DrugsMethylprednisolone·Prednisone

Fondazione Telethon Ets

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Italy

27/10/2026

Phase I/II

A Phase Ib/II, open-label, safety and tolerability trial of intravenous obrixtamig in combination with pumitamig and standard of care (carboplatin, etoposide) in patients with extensive stage small cell lung carcinoma.

2026-525459-99-00Small cell lung carcinoma

DrugsObrixtamig·Pumitamig·Tocilizumab·Carboplatin

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Neoplasms

Germany, Spain, France, Poland, Belgium, Netherlands

26/10/2026

Phase I/II

A Multicenter, Dose-Escalation and Dose-Finding, First-In-Human Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Subcutaneously Administered RO7871996 in Participants with Active Systemic Lupus Erythematosus

2026-527221-35-00Active Systemic Lupus Erythematosus (SLE)

DrugObinutuzumab

F. Hoffmann-La Roche AG

Immune System Diseases

Spain

23/10/2026

Phase I/II

A Phase 1/2 Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of ARV-6723 Administered as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors

2026-525614-57-00Advanced Cancer

DrugPembrolizumab

Arvinas Operations Inc.

Neoplasms

Spain, France

22/10/2026

Phase I/II

Phase I/II Clinical Study to Assess the Safety, Efficacy and Select the Dose of NFL-102 as a Tobacco and Nicotine Cessation Therapy (TONIC trial)

2026-527266-77-00Tobacco dependence

Nfl Biosciences

Mental Disorders

France

20/10/2026

Phase I/II

A Double-blind, Randomized, Controlled, Multiple Ascending Dose Study of Intrathecally Administered CMP-002 in Participants with SYNGAP1-Related Disorder (ASCEND)

2026-526220-46-00SYNGAP1-Related Disorder

Camp4 Therapeutics Corp.

Nervous System Diseases

France, Spain, Italy, Netherlands, Poland, Germany

20/10/2026

Phase I/II

A first-in-human phase 1/2 trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of SOT109 in patients with advanced unresectable or metastatic colorectal cancer

2026-526235-19-00Advanced unresectable or metastatic colorectal cancer

SOTIO Biotech a.s.

Neoplasms

Czechia, Spain, France, Belgium

20/10/2026

Phase I/II

A Phase I First-in-Human Dose Escalation Trial to Evaluate the Safety and Efficacy of ARI-HER2 (HER2BBz CAR-T Cells) in Patients with HER2Positive Advanced Breast Cancer

2026-527365-30-00Patients with HER2Positive Advanced Breast Cancer

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Therapeutics

Spain

19/10/2026

Phase I/II

A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of VRN110755 in Patients with Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)

2025-523122-40-00EGFR-mutant Non–Small Cell Lung Cancer (NSCLC)

Voronoi Inc.

Neoplasms

France, Poland, Spain

19/10/2026

Phase I/II

A Phase Ib/IIa open-label, multicenter, dose-escalation and proof-of-concept trial evaluating Benfo-Oxythiamine (B-OT) as an investigational add-on to standard of care (SOC) lutetium (177Lu) vipivotide tetraxetan therapy (Pluvicto®) in adults with metastatic castration-resistant prostate cancer (mCRPC) and stable disease after two prior cycles of SOC

2026-527059-25-00metastatic castration-resistant prostate cancer (mCRPC)

Benfovir AG

Male Urogenital Diseases

Germany

16/10/2026

Phase I/II

Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of VSA012 Injection in Participants with Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Are Complement Inhibitor Naïve or Have Not Received Complement Inhibitor Therapy Recently, as well as in Those with Persistent Anemia Despite Stable C5 Complement Inhibitor Therapy

2026-526187-21-00Paroxysmal nocturnal hemoglobinuria (PNH)

DrugVSA012

Bisirna Therapeutics Pte. Ltd.

Hemic and Lymphatic Diseases

Spain, Germany, Italy, France

15/10/2026

Phase I/II

A phase Ib/II of chemotherapy-free trial evaluating Zongertinib in combination with Ribociclib, Endocrine Therapy and Trastuzumab in patients with ER-positive/HER2-positive metastatic breast cancer - PATRICIA-3 -

2026-526704-67-00Patients with metastatic ER-positive/HER2-positive BC who h…

DrugsZongertinib·Ribociclib

Solti Group

Neoplasms

Spain

15/10/2026

Phase I/II

Evaluation of Safety, Treatment Response and Biological Effects of DFI205 in Systemic Autoimmune Rheumatic Diseases (SARDs); a Phase 1/2a First-in- Human (FIH) Study

2026-526672-24-00Systemic Autoimmune Rheumatic Diseases (SARDs)

Diabetes Free Inc.

Immune System Diseases

Germany

14/10/2026

Phase I/II

SNIPER-LTFU: Long-term follow-up study of patients administered with RR001 in the interventional Parent SNIPER study

2026-525714-59-00Locally advanced, non-resectable pancreatic adenocarcinoma,…

Eir Biotherapies S.r.l.

Neoplasms

Italy

09/10/2026

Phase I/II

A Phase 1b/2a, Open-label Multi-Centre Dose-Escalation and Expansion Study of DM199, in Participants undergoing Expectant Management for Preterm Preeclampsia

2026-527887-33-00Preterm preeclampsia

Diamedica Therapeutics Inc.

Female Urogenital Diseases and Pregnancy Complications

Germany

09/10/2026

Phase I/II

Neoadjuvant trastuzumab, pertuzumab and zongertinib without chemotherapy in HER2-positive breast cancer: the TRAIN-5 study

2026-526214-93-00Breast cancer

DrugZongertinib

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Neoplasms

Netherlands

08/10/2026

Phase I/II

Hepatic arterial infusion versus intravenous oxaliplatin in a safety, feasibility, and pharmacokinetic study of liver-dominant malignancies – ARTEMIS OXYS-I trial

2026-527509-39-01Colorectal liver metastases, Intrahepatic cholangiocarcinoma

DrugsPantoprazole·Omeprazole·Capecitabine

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Neoplasms

Netherlands

07/10/2026

Phase I/II

First-in-human study of ATX-898 as monotherapy and in combination with other anti-neoplastic agents, in participants with advanced solid tumors

2026-526514-85-00Advanced solid tumors

DrugsRibociclib·Abemaciclib·Fulvestrant

Antares Therapeutics Inc.

Neoplasms

Netherlands, Spain, France, Italy

05/10/2026

Phase I/II

A Phase Ib/II, open-label, safety and tolerability trial of obrixtamig in combination with ZL-1310 in patients with poorly differentiated NEC

2026-525634-27-00Extrapulmonary neuroendocrine carcinoma of large cell histo…

DrugsZL-1310·Obrixtamig·Tocilizumab·Atezolizumab

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Neoplasms

Poland, France, Belgium, Germany, Netherlands, Spain

05/10/2026

Phase I/II

A phase 1/2 clinical study evaluating MDX2003 in participants with relapsed, progressive, or refractory B-cell malignancies

2026-526661-26-00Relapsed/Refractory B-cell Malignancies

Modex Therapeutics Inc.

Hemic and Lymphatic Diseases

Spain, Italy

01/10/2026

Phase I/II

A Phase 1/2, Multicenter, First-in-Human, Dose Escalation and Expansion Study Evaluating CHM-029, as Monotherapy and in Combination with Standard Therapies in Participants with Relapsed or Refractory, or Newly Diagnosed Acute Myeloid Leukemia (AML) with NPM1 Mutations, KMT2A or NUP98 Rearrangements

2026-526409-14-00Acute Myeloid Leukemia

DrugsPosaconazole·Daunorubicin·Cytarabine·Azacitidine

Charm Therapeutics Limited

Neoplasms

France, Germany, Spain, Poland, Netherlands

30/09/2026

Phase I/II

ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination with Ipilimumab or Cabozantinib in Participants with Advanced Renal Cell Carcinoma (RCC)

2026-527163-15-00Advanced Renal Cell Carcinoma

DrugsCabozantinib·Ipilimumab

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Ireland, Romania, Italy, Spain, Czechia, Finland, France, Germany

24/09/2026

Phase I/II

A follow-up extension study of patients who completed the U-LaserPrint-1 clinical trial to evaluate the long-term safety and efficacy of treatment with InvivoLPrint-U.

2026-527804-26-00Muscle-invasive bladder cancer (MIBC) patients, eligible fo…

Phosprint S.A.

Neoplasms

Greece

17/09/2026

Phase I/II

A study assessing the safety, tolerability, pharmacokinetics and efficacy of single and multiple doses of NNC0638-0355 in participants with overweight or obesity

2026-526797-16-00Obesity and overweight

Novo Nordisk A/S

Nutritional and Metabolic Diseases

Netherlands

14/09/2026

Phase I/II

A Phase Ia/II Randomized Controlled Trial of Daratumumab Alone Versus Daratumumab Plus Abatacept for resistant active Antibody-Mediated Rejection in Kidney Transplant Recipients

2026-526730-73-00active Antibody-Mediated Rejection in Kidney Transplant Re…

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Immune System Diseases

Spain

08/09/2026

Phase I/II

A Long-Term Follow-Up Study to Assess the Safety and Efficacy of B-Cell-Directed Therapy in Patients with Systemic Autoimmune Disease (B-CARE)

2026-526888-37-00systemic autoimmune diseases

Universitaetsklinikum Erlangen AöR

Immune System Diseases

Germany

07/09/2026

Phase I/II

Phase 1/2, first-in-human, randomized, double-blind, reference-controlled study to evaluate the safety and immunogenicity of an extemporaneously mixed Combo Inactivated Influenza Vaccine (Green Cross [GC]-IIV; 15µg of each hemagglutinin [HA])/OVX836 (480µg), in comparison to GC-IIV (15µg of each HA) concomitantly administered with OVX836 (480µg), GC-IIV alone (15 µg each HA), OVX836 alone (480µg), and a licensed reference trivalent IIV (Vaxigrip®; 15µg of each HA), administered intramuscularly (IM) in healthy participants

2026-526939-19-00Influenza disease

Osivax

Virus Diseases

Belgium

04/09/2026

Phase I/II

Perioperative zanidatamab combined with chemotherapy in HER2-positive locally advanced operable gastroesophageal adenocarcinoma (GEA): a Phase 1b/2a single-arm trial

2025-523483-20-00Gastroesophageal adenocarcinoma (GEA)

DrugsZanidatamab·Tislelizumab

UZ Leuven

Neoplasms

Belgium

31/08/2026

Phase I/II

An Open-Label, Multicenter Phase 1/2 Study to Assess the Safety, Tolerability, and Efficacy of Intracochlear Ascending Dose Injections of SENS-601 Followed by Expansion Cohort in Pediatric Population With Hearing Loss Related to Biallelic Pathogenic Variation(s) of GJB2, As Well As to Demonstrate the Performance of the Administration System, Its Safety, Its Clinical Benefit, and Its Usability.

2026-525698-38-00Hearing Loss Related to biallelic pathogenic variation (s) …

Sensorion

Otorhinolaryngologic Diseases

France

31/08/2026

Phase I/II

A Phase 1/2, Open-Label, Multicenter, Multi-cohort Study of S241656 as Monotherapy or in Combination with other Antileukemic Agents in participants with Selected Myeloid Malignancies

2025-525128-88-00Patients with Acute Myeloid Leukemia (AML), Myelodysplastic…

DrugPosaconazole

Institut De Recherches Internationales Servier IRIS

Neoplasms

Netherlands, Spain, Germany, Italy, France, Finland

27/08/2026

Phase I/II

A combined phase I/IIa trial to investigate the safety and pharmacokinetics of StaphAcute in healthy participants and patients with Staphylococcus aureus bacteremia - StaphAcute

2024-511586-10-01Phase IIa: patients with methicillin susceptible (MSSA) or …

University Of Cologne

Bacterial Infections and Mycoses

Germany

24/08/2026

Phase I/II

A Prospective Diagnostic Trial of Al[¹⁸F]F-NOTA-folate PET in Patients with Suspected Cardiac Sarcoidosis or Infective Endocarditis and Healthy Volunteers (FOL-CARD)

2026-526655-59-00Cardiac Sarcoidosis, Infective endocarditis

Turku University Hospital

Cardiovascular Diseases

Finland

24/08/2026

Phase I/II

A multicenter, non-therapeutic, interventional, long-term follow-up clinical trial to evaluate the safety of autologous PRAME-directed TCR T cell therapy IMA203 or IMA203CD8 in patients with previously treated, advanced and/or metastatic solid tumors

2026-525827-25-00Solid tumors

DrugAnzu-cel

Immatics US Inc.

Neoplasms

Germany

21/08/2026

Phase I/II

Phase I/II trial of Dinutuximab beta in combination with Irinotecan and Rapamycin in pediatric, adolescents and adult patients with relapsed/refractory bone tumors. BONE DINIRRA

2026-525463-40-00osteosarcomas, chondrosarcomas, Ewing sarcomas, Ewing-like …

DrugsDinutuximab beta·Sirolimus·Irinotecan

Les Hopitaux Universitaires De Strasbourg

Neoplasms

France

20/08/2026

Phase I/II

A Modular Open-label, Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Ascending Doses of AZD4956 as Monotherapy, and in Combination with Anti-Cancer Agents in Participants with Advanced/Metastatic Homologous Recombination Repair Defective Solid Tumours (PARTHENON)

2025-524171-22-00Solid Tumors

DrugSaruparib

AstraZeneca AB

Neoplasms

Spain

20/08/2026

Phase I/II

A Phase 1/2 Trial of TER-2013 in Patients with Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations

2025-525036-34-00Solid Tumours

DrugsImlunestrant·Fulvestrant

Terremoto Biosciences Inc.

Neoplasms

Spain, Ireland, Hungary, Romania, France, Portugal, Belgium, Poland

18/08/2026

Phase I/II

A Phase 1/2 Open-label, Multi-center Study to Evaluate the Safety and Clinical Activity of GSK5926371 in Adult Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphomas (B-NHL)

2025-524915-36-00Lymphoma, Non-Hodgkin

Glaxosmithkline Research & Development Limited

Neoplasms

Italy, Germany, Spain, Finland, France

17/08/2026

Phase I/II

An open-label phase I/II, single-center, interventional singlearm basket trial of UKT-CART19.1 in patients with relapsed/refractory autoimmune diseases

2024-519491-60-00ANCA associated vasculitis (AAV), Immune thrombocytopenic p…

Universitaetsklinikum Tuebingen AöR

Immune System Diseases

Germany

14/08/2026

Phase I/II

A two-part, randomised, double-blind, placebo-controlled, parallel-group, 12week trial investigating the safety, tolerability, pharmacokinetics and efficacy of XEN-D0501 in obese participants

2026-525869-42-00Obesity

Pila Pharma AB

Nutritional and Metabolic Diseases

Sweden

13/08/2026

Phase I/II

Preventive Dendritic Cell vaccination for Lynch Syndrome (PREVENT-Lynch)

2025-524046-10-00Lynch Syndrome

Radboud universitair medisch centrum Stichting

Digestive System Diseases

Netherlands

12/08/2026

Phase I/II

Bioequivalence clinical trial of two formulations of quetiapine.

2026-527162-72-00Healthy participants

Laboratorios Alter S.A.

Mental Disorders

Spain

11/08/2026

Phase I/II

Evaluation of Interference and Synergy of Anti-Circumsporozoite Antibodies on GA2-induced Immunity

2026-525353-37-00Plasmodium falciparum malaria

Leids Universitair Medisch Centrum (LUMC)

Parasitic Diseases

Netherlands

10/08/2026

Phase I/II

Trial to study the safety, pharmacokinetics and preliminary antitumour activity of ODM-216 in patients with cancer

2026-525864-17-00Advanced solid tumours

Orion Corporation

Neoplasms

Spain

06/08/2026

Phase I/II

A Phase 1b/2a first-in-human, multicentre, randomized, double-blind, placebo-controlled study of multiple ascending dose (Part1) followed by an open-label extension (Part2) to assess the safety, tolerability, and pharmacokinetics of intrathecally administered S233107 in participants with spinocerebellar ataxia type 3

2025-525111-17-00Spinocerebellar ataxia type 3

Institut De Recherches Internationales Servier IRIS

Nervous System Diseases

France, Denmark, Spain, Portugal

30/07/2026

Phase I/II

A Phase I/II, randomized, placebo-controlled, multi-arm, dose-finding study to evaluate the safety, efficacy and immunogenicity of an Acne mRNA vaccine candidate in adults with moderate to severe acne 18 to 45 years of age

2025-521740-38-00Acne

DrugAcne mRNA vaccine

Sanofi Vaccines US Inc.

Skin and Connective Tissue Diseases

Spain, Germany, Poland

29/07/2026

Phase I/II

Melanoma-TBK1-inhibitor enhanced Immuno Therapy with Checkpoint Inhibitors: a Phase IB/II Trial in Unresectable Stage III or Stage IV Cutaneous Melanoma

2026-526821-16-00Unresectable Stage III or Stage IV Cutaneous Melanoma

DrugsNivolumab·Pembrolizumab

Karolinska University Hospital

Neoplasms

Sweden

28/07/2026

Phase I/II

Phase I/II Trial to Determine Safety and Efficacy of non-Viral Allogeneic Dual CD123/33-Chimeric Antigen Receptor CIK (CARCIK-CD123/33) Cells in Adult and Pediatric Patients with Relapse/Refractory Acute Myeloid Leukemia (AML) and Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

2025-524977-18-00Acute myeloid leukemia and Blastic plasmacytoid dendritic c…

Fondazione Tettamanti, Fondazione IRCCS San Gerardo Dei Tintori

Neoplasms

Italy

27/07/2026

Phase I/II

A Phase 1/2, dose escalation and expansion study of TRI-611, an oral ALK molecular glue degrader in participants with advanced ALK-positive NSCLC

2025-524418-27-00Advanced ALK-positive NSCLC

Triana Biomedicines Inc.

Respiratory Tract Diseases

France, Italy, Germany, Spain

22/07/2026

Phase I/II

A Phase 1/2a, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BMS-986528 in Participants with Refractory Rheumatoid Arthritis

2025-520666-22-00Refractory, difficult-to-treat Rheumatoid Arthritis

DrugTocilizumab

Bristol-Myers Squibb Services Unlimited Company

Immune System Diseases

Poland, Italy, Spain, Germany

22/07/2026

Phase I/II

A Phase 1/2 First-Time-in-Human, open-label, multicenter, dose escalation and dose optimization study of GSK5471713 in adult participants with metastatic castration resistant prostate cancer (mCRPC).

2025-523874-17-00Neoplasms, Prostate

Glaxosmithkline Research & Development Limited

Neoplasms

Netherlands, France, Spain

21/07/2026

Phase I/II

A phase I/IIa safety, dose finding and feasibility trial of CD30/CEA CART in patients with liver metastases from CEA positive colorectal adenocarcinoma

2026-526225-18-00Colorectal Adenocarcinoma

Universitaetsklinikum Regensburg AöR

Neoplasms

Germany

20/07/2026

Phase I/II

Phase I/II clinical trial on the use of central nervous system administrations of CART-NKG2D or NKIL15 cells in children, adolescent and young adults with recurrent/refractory high grade Central Nervous System tumours (CINK-CAR)

2026-525876-24-00Central nervous system tumours

Hospital Universitario La Paz

Neoplasms

Spain

15/07/2026

Phase I/II

FLAsH-IV-AML: A phase I/II multi-center study to assess the tolerability and efficacy of the addition of hydroxyurea to salvage treatment with fludarabine, ara-C, idarubicin and venetoclax for adults with relapsed or refractory acute myeloid leukemia

2026-526961-76-00Adults (≥ 18 years of age) with relapsed or refractory acut…

DrugsIdarubicin·Cytarabine·Fludarabine·Venetoclax

Karolinska University Hospital

Hemic and Lymphatic Diseases

Sweden

14/07/2026

Phase I/II

A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) given as Monotherapy or in Combination with Antimyeloma Regimens in Subjects with Multiple Myeloma

2025-525105-20-00Multiple Myeloma (MM), Multiple Myeloma (MM)

DrugEtentamig

AbbVie Deutschland GmbH & Co. KG

Neoplasms

Germany, Poland, Czechia, Belgium, France, Greece, Sweden, Portugal, Italy

13/07/2026

Phase I/II

EXUROC Bladder Target - A phase Ib/ll study to determine the safety, tolerability, and efficacy of LP-184 treatment in patients with advanced/metastatic urothelial carcinoma

2026-525808-94-00Oncology

Region Hovedstaden

Neoplasms

Denmark

10/07/2026

Phase I/II

A PHASE 1/2 STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFECTS ON CLINICAL OUTCOMES OF PEGTIBATINASE (TVT-058) ADMINISTERED SUBCUTANEOUSLY IN SUBJECTS WITH CYSTATHIONINE BETASYNTHASE-DEFICIENT HOMOCYSTINURIA (COMPOSE)

2023-509074-31-00Classical Homocystinuria

DrugPegtibatinase

Travere Therapeutics Inc.

Nutritional and Metabolic Diseases

France

07/07/2026

Phase I/II

A Phase 1b-2, Open-Label, Dose-Escalation, Expansion and Optimization Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of LRK-4189 Alone and in Combination with mFOLFOX6 or FOLFIRI in Patients with Solid Tumors

2026-525629-20-00Solid tumors

Larkspur Biosciences Inc.

Neoplasms

France

03/07/2026

Phase I/II

A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE849 in Patients with DLL3 Expressing Tumors Including Small Cell Lung Cancer

2025-523438-24-00DLL3 Expressing Tumors Including Small Cell Lung Cancer

DrugDurvalumab

Ideaya Biosciences Inc.

Neoplasms

France, Spain

01/07/2026

Phase I/II

The headache- and migraine-inducing effects of apremilast in women with migraine without aura

2026-525987-16-00Migraine without aura

DrugApremilast

Syddansk Universitet (University of Southern Denmark)

Nervous System Diseases

Denmark

01/07/2026

Phase I/II

A Phase 1/2 Study of Inhaled KB707 in Patients with Advanced Solid Tumor Malignancies Affecting the Lungs

2025-522723-98-00solid tumor

Krystal Biotech Inc.

Neoplasms

France, Spain

30/06/2026

Phase I/II

Phase 1-2, Open-Label, Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION337 in Patients with Dravet Syndrome

2025-523835-20-00Dravet Syndrome

Ionis Pharmaceuticals Inc.

Nervous System Diseases

Spain, France, Belgium, Portugal, Germany

30/06/2026

Phase I/II

PET imaging For eaRly predictiOn of respoNse to neoadjuvanT tReatment in lUNg caNcER

2025-524791-30-00Non small cell lung cancer

Radboud universitair medisch centrum Stichting

Respiratory Tract Diseases

Netherlands, Germany

29/06/2026

Phase I/II

A Phase 1/2 Open-Label, Multicenter Study of RAS(ON) inhibitors in Combination with Ivonescimab with or without Other Anti-Cancer Agents in Patients with Solid Tumors

2025-524623-50-00Solid Tumors

DrugsElironrasib·RMC-9805·Erbitux·Ivonescimab

Revolution Medicines Inc.

Neoplasms

France, Poland, Ireland, Spain, Greece, Germany, Italy, Sweden, Belgium

29/06/2026

Phase I/II

Exploratory study of the performance of dynamic PET-CT acquisition to predict 6-month morphological response in patients with hepatocellular carcinoma treated with selective internal radiotherapy

2026-526324-48-00HCC – Hepatocellular Carcinoma

Centr Georges Francois Leclerc

Neoplasms

France

22/06/2026

Phase I/II

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 / 2 Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of Single Ascending Doses of TRCN-1023 Administered by Intrathecal Injections to Adult People Living with Amyotrophic Lateral Sclerosis

2025-523111-11-00Amyotrophic lateral sclerosis

Trace Neuroscience Inc.

Musculoskeletal Diseases

Germany, Netherlands

22/06/2026

Phase I/II

Long-term Follow-up (LTFU) Study of Participants in any iECURE Protocol Using an Investigational Product

2024-514190-21-00Ornithine Transcarbamylase Deficiency (OTC)

Iecure Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Spain, France, Slovenia

18/06/2026

Phase I/II

A Phase I/II Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6621, a T Cell-engaging Antibody That Targets STEAP2, CD3, and CD8 in Adult Participants With Metastatic Prostate Cancer (ACTIVATED-4-PC)

2025-520626-37-00Metastatic Prostate Cancer

AstraZeneca AB

Neoplasms

Belgium, Spain, Poland, Italy, Netherlands

16/06/2026

Phase I/II

Phase I-IIa, national, multicenter, clinical trial to evaluate the safety and preliminary efficacy of CAR-T CD19 therapy in patients with refractory lupus nephritis.

2025-522449-23-00Refractory Lupus Nephritis

Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz

Immune System Diseases

Spain

11/06/2026

Phase I/II

ACTIVATE - Phase 1 Clinical Trial evaluating the combination of Actinomycin D and venetoclax in patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)

2025-524728-22-01Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)

Assistance Publique Hopitaux De Paris

Not possible to specify

France

10/06/2026

Phase I/II

A Phase 1/2, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients with Advanced KRAS G12D-Mutant Solid Tumors

2025-523432-39-01Advanced KRAS G12D-Mutant Solid Tumors

Verastem Inc.

Neoplasms

Italy, France, Germany, Belgium, Spain, Netherlands

09/06/2026

Phase I/II

A Phase 1b/2 Open-label Study Evaluating different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-based regimens in First-line Extensive Stage Small Cell Lung Cancer

2025-521032-11-00Small cell lung cancer extensive stage

Merck Sharp & Dohme LLC

Neoplasms

Germany, Poland, Greece, Italy, France, Spain

08/06/2026

Phase I/II

TSRA196-AAT-201: A Phase 1/2, Open-Label, Multi-Center, Dose Escalation, Dose Expansion, and Single Repeat Dose Study of TSRA-196 in Adults With the PiZZ Genotype Who Have Lung and/or Liver Disease Associated with Severe Alpha-1 Antitrypsin Deficiency

2025-523497-16-00Lung and/or Liver Disease Associated with Alpha-1 Antitryps…

Tessera Therapeutics Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Ireland, Sweden, Netherlands

08/06/2026

Phase I/II

A PHASE IB/II STUDY TO EVALUATE SAFETY AND EFFICACY OF BEXMARILIMAB IN COMBINATION WITH DOXORUBICIN IN METASTATIC SOFT-TISSUE SARCOMA (BEXAR Study)

2025-525144-18-00Advanced or metastatic histologically confirmed soft tissue…

Medica Scientia Innovation Research S.L.

Neoplasms

Spain

08/06/2026

Phase I/II

KontRASt-R: An open-label, multi-center, rollover study for participants who have been previously enrolled into a Novartis-sponsored opnurasib (JDQ443) study and are continuing to benefit from opnurasib as a single agent or in combination with other study treatments

2025-523537-26-00Locally advanced or metastatic KRAS G12C-mutated non-small …

Novartis Pharma AG

Neoplasms

Spain, Italy, France, Denmark, Belgium

08/06/2026

Phase I/II

REGENOVAR: A Phase I/II Study of Ubamatamab Plus Carboplatin, Paclitaxel, and Bevacizumab as Salvage Therapy in Ovarian Cancer with Poor Response to First-Line Chemotherapy.

2025-524232-20-00Patients with poor prognostic ovarian cancers based on the …

DrugsUbamatamab·Filgrastim·Paclitaxel·Bevacizumab

Asso De Recherche Cancers Gynecologiques

Neoplasms

France

04/06/2026

Phase I/II

A study on the safety of and immune response to different doses of RSV/hMPV combination and hMPV vaccines in adults

2025-524456-58-00Respiratory Syncytial Virus Infections+Metapneumovirus

GlaxoSmithKline Biologicals

Respiratory Tract Diseases

Belgium

04/06/2026

Phase I/II

A Phase 1b/2 Study to Evaluate NB-4746 in Participants with Amyotrophic Lateral Sclerosis.

2025-523939-18-00Amyotrofic Lateral Sclerosis (ALS)

DrugRiluzole

Nura Bio Inc.

Nervous System Diseases

Poland, Netherlands, Italy, Spain

03/06/2026

Phase I/II

A Phase 1/2, Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamic, and Antitumor Activity of CR-001 in Adult Participants with Locally Advanced or Metastatic Solid Tumors.

2025-523590-42-00Locally Advanced or Metastatic Solid Tumors

Crescent Biopharma Inc.

Neoplasms

Spain, Ireland, Italy, France, Romania

02/06/2026

Phase I/II

A Phase 1b/2a, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants with Late-Onset Pompe Disease

2025-524082-25-00Late-Onset Pompe Disease

Denali Therapeutics Inc.

Musculoskeletal Diseases

Germany, Netherlands

01/06/2026

Phase I/II

An open-label, single-arm, phase 1/2 first-in-human study to assess the safety and efficacy of autologous CD34+ cells transduced with a lentiviral vector encoding the human NCF1 gene (SGX-001) in paediatric and adult patients with chronic granulomatous disease caused by p47phox deficiency

2025-524423-50-00Chronic granulomatous disease (CGD) caused by p47phox defic…

Somagenetix AG

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Germany, Spain

29/05/2026

Phase I/II

C6461006 - An Interventional Phase 1b/2, Open-Label Study to Investigate the Safety, Antitumor Activity, and Pharmacokinetics of PF-08634404 Monotherapy or in Combination With Enfortumab Vedotin in Adult Participants With Locally Advanced or Metastatic Urothelial Cancer.

2025-523523-21-00Locally Advanced or Metastatic Urothelial Cancer

Pfizer Inc.

Neoplasms

Netherlands, Spain

29/05/2026

Phase I/II

Prospective, multicentre, two-arms, I/II phase study to Optimise and Personalise Immunological Therapy of relapsed chronic lymphocytic leukaemia patients (OPTIC)

2024-513917-11-01Adult patients with chronic lymphocytic leukemia/small lymp…

DrugsObinutuzumab·Daratumumab·Venetoclax

Uniwersytet Medyczny W Lublinie

Hemic and Lymphatic Diseases

Poland

29/05/2026

Phase I/II

A Phase 1b/2 Study to Evaluate the Safety and Efficacy of MK‑1045 Monotherapy or in Combination with Other Anticancer Agents in Participants with Non-Hodgkin Lymphoma

2025-523005-15-00Non-Hodgkin Lymphoma

Merck Sharp & Dohme LLC

Neoplasms

Poland, Italy, France, Germany, Spain

28/05/2026

Phase I/II

A Phase I/II open label study of DJI136, a DLL3-targeted CAR-T therapy, in adult patients with ES-SCLC

2025-523276-23-00Extensive stage small cell lung cancer

DrugsBendamustine·Tocilizumab·Fludarabine·Cyclophosphamide

Novartis Pharma AG

Neoplasms

Spain, France

27/05/2026

Phase I/II

Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas

2025-523997-18-00Sarcoma

Glaxosmithkline Research & Development Limited

Neoplasms

France

27/05/2026

Phase I/II

LIGHTBEAM-U01 Substudy 01D: A Phase 1b/2 Substudy to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors

2025-522339-32-00Neoplasm malignant

DrugIfinatamab Deruxtecan

Merck Sharp & Dohme LLC

Neoplasms

France, Spain, Sweden, Germany, Italy, Belgium, Denmark, Czechia, Hungary, Netherlands, Slovakia

26/05/2026

Phase I/II

A 2-part phase 1/2 open-label trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ODM-212 in combination with anti-cancer therapy in participants with advanced solid tumours

2025-524620-22-00Neoplasms benign malignant and unspecified (incl. cysts and…

DrugsODM-212·Sotorasib·Ipilimumab·Nivolumab

Orion Corporation

Neoplasms

Finland, Denmark, Spain, France

22/05/2026

Phase I/II

An Open Label, Single Arm, Phase I/II Clinical Study of Autologous CD4+ T-Cells Edited Ex-Vivo at the CD40LG Locus by CRISPR/Cas9 and IDLV-based vector in Patients with X-linked Hyper IgM Syndrome Type 1 (HIGM1)

2025-524635-39-00X-linked immunodeficiency with hyper-IgM type 1 (HIGM1)

Fondazione Telethon Ets, San Raffaele Hospital

Immune System Diseases

Italy

20/05/2026

Phase I/II

mRNA Therapy to restore lymphatic flow in secondary lymphedema

2024-520149-22-00Lymphedema

Centre Hospitalier Universitaire De Toulouse

Hemic and Lymphatic Diseases

France

18/05/2026

Phase I/II

A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination with Nivolumab in Participants with Relapsed/Refractory Small Cell Lung Cancer

2025-524090-16-00Relapsed/Refractory Small Cell Lung Cancer

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Italy, Spain, Romania

18/05/2026

Phase I/II

A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety and Efficacy of Aritinercept, a Dual BAFF/APRIL Inhibitor, in Patients with Generalized Myasthenia Gravis

2025-525127-27-00Generalized Myasthenia Gravis

Aurinia Pharmaceuticals Inc.

Immune System Diseases

Poland, Spain, Denmark

15/05/2026

Phase I/II

A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors, including Checkpoint Inhibitor Naïve Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors

2026-525248-13-00Advanced Solid Tumors

Eikon Therapeutics Inc.

Neoplasms

France, Spain, Norway, Italy, Germany, Austria, Poland, Finland, Belgium, Denmark, Portugal

15/05/2026

Phase I/II

Phase 1/2 evaluating the addition of venetoclax to standard 3+7 and midostaurin induction treatment in patients with FLT3-mutated Acute Myeloid Leukemia eligible to intensive chemotherapy - MIDOVEN

2024-517130-17-00FLT3-mutated Acute Myeloid Leukemia

DrugVenetoclax

Centre Hospitalier Universitaire De Bordeaux

Neoplasms

France

13/05/2026

Phase I/II

A Phase 1/2a, Open-Label, Dose-Escalation and Dose-Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti PD-1-IL2RA-IL2 Fusion Protein) Alone or in Combination with Cemiplimab in Patients with Advanced Solid Organ Malignancies

2025-523399-22-00Advanced Solid Tumours, Melanoma, Clear-Cell Renal-Cell Car…

DrugsREGN10597·Cemiplimab

Regeneron Pharmaceuticals Inc.

Neoplasms

Italy, Spain, Germany, France

08/05/2026

Phase I/II

LAMP-COVID: Locating Amyloid-containing Microclots with total-body PET in post-COVID syndrome

2025-522348-42-00post-COVID syndrome (long COVID)

Amsterdam UMC Stichting

Virus Diseases

Netherlands

07/05/2026

Phase I/II

Single-centre, randomised, double-blind, split-face comparative design clinical trial to evaluate the efficacy and safety of the topical formulation with 4% hydroquinone and 0,025% tretinoin versus the formulation with 4% hydroquinone in patients with facial melasma

2025-521806-16-00facial melasma

Mesoestetic Pharma Group S.L.

Skin and Connective Tissue Diseases

Spain

05/05/2026

Phase I/II

PHASE IB/II STUDY TO EVALUATE SAFETY AND PRELIMINARY EFFICACY OF ZANIDATAMAB IN COMBINATION WITH TUCATINIB AND CHEMOTHERAPY (CAPECITABINE OR ERIBULIN MESYLATE) IN HER2-POSITIVE ADVANCED BREAST CANCER (The JAZMINE Study)

2025-524613-89-00HER2 positive advanced breast cancer

Medica Scientia Innovation Research S.L.

Neoplasms

Spain

05/05/2026

Phase I/II

A Phase 1b/2a, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MB-001 in Participants With Moderately to Severely Active Ulcerative Colitis

2025-524719-35-00Ulcerative Colitis

Mage Biologics Inc.

Digestive System Diseases

Poland

29/04/2026

Phase I/II

A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Subjects with Active Idiopathic Inflammatory Myopathy or Active Juvenile Idiopathic Inflammatory Myopathy

2025-521145-24-01Active Idiopathic Inflammatory Myopathy including dermatomy…

DrugEndoxan

Cabaletta Bio Inc.

Immune System Diseases

Italy, Spain, Germany

28/04/2026

Phase I/II

Study of IBI3009 alone or in combination with other therapies for extensive-stage small cell lung cancer

2025-523972-21-00Extensive-Stage Small Cell Lung Cancer

Fortvita Biologics (USA) Inc.

Respiratory Tract Diseases

Poland, Denmark, Spain

27/04/2026

Phase I/II

A multi-center, open-label, phase I/II study to evaluate the safety and efficacy of asciminib with chemotherapy followed by blinatumomab in pediatric, adolescent, and young adult patients with relapsed or refractory BCR::ABL1-positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)

2025-522019-40-00relapsed or refractory BCR::ABL1-positive (Philadelphia pos…

DrugsAsciminib·Hydrocortisone·Blinatumomab·Cytarabine

Novartis Pharma AG

Neoplasms

Italy, Spain, Germany, Netherlands, France, Denmark, Czechia

27/04/2026

Phase I/II

A Multicenter, Open-label, Phase 1/2 Safety Run-in and Expansion Study of PM54 in Combination With Immunotherapy Evaluating Safety and Efficacy in Adult Participants who were Previously Treated for Advanced Malignancies

2025-523774-16-00Advanced malignancies

DrugsPM54·Pembrolizumab

Pharma Mar S.A.

Neoplasms

Spain, France, Italy

24/04/2026

Phase I/II

A Phase 1/2 Open-Label, Single Ascending Dose, First-In-Human Study to Assess Safety and Tolerability of Endoscopic Ultrasound-Guided Pancreatic Infusion of RJVA-001 in Adults With Inadequately Controlled Type 2 Diabetes on Multiple Glucose-Lowering Agents.

2025-524438-24-00Type 2 Diabetes

Fractyl Health Inc.

Nutritional and Metabolic Diseases

Netherlands

23/04/2026

Phase I/II

Exploratory study on the effect of Rimonabant on hand function in patients with spinal cord injury (RIMOHANDOPEN)

2025-524279-22-00Spinal cord injury

Sinfatin S.L.

Musculoskeletal and Neural Physiological Phenomena

Spain

22/04/2026

Phase I/II

COLOMBE - A multicentre, single arm, phase 1/2 study, aiming to assess the safety and efficacy of nivolumab and imiquimod combination in vulvar squamous cell carcinoma patients

2025-524759-29-00Vulvar Squamous Cell Carcinoma (VSCC) patients

Centre Leon Berard

Female Urogenital Diseases and Pregnancy Complications

France

22/04/2026

Phase I/II

ROSETTA HCC-206: An Open-Label, Multi-Center, Randomized Phase 1/2 Study of Pumitamig Alone or In Combination with Ipilimumab in Participants with First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC)

2025-523602-33-00Advanced or unresectable Hepatocellular Carcinoma (HCC)

DrugIpilimumab

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Poland, Spain, Germany, France, Italy

22/04/2026

Phase I/II

A single-arm, open-label, multi-centre, phase I/II first-in-human study evaluating the safety and clinical activity of QEL-005, an autologous CAR T-regulatory cell therapy treatment targeting CD19, in patients with diffuse cutaneous systemic sclerosis (dcSSc) and in patients with difficult to treat rheumatoid arthritis (D2TRA).

2025-523971-46-00Diffuse cutaneous systemic sclerosis (dcSSc) Difficult to t…

Quell Therapeutics Limited

Musculoskeletal Diseases

Spain, Germany

21/04/2026

Phase I/II

C6461008 - AN INTERVENTIONAL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA

2025-523524-53-00ADVANCED OR METASTATIC RENAL CELL CARCINOMA

Pfizer Inc.

Neoplasms

Germany, Spain

21/04/2026

Phase I/II

A Phase 1/2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients with KRAS, BRAF and Other Selected RAS/MAPK Mutation-Positive Malignancies

2025-523474-16-00Malignancies with Documented KRAS, BRAF and Other Selected …

Institut De Recherches Internationales Servier IRIS

Neoplasms

France, Spain, Denmark, Italy

21/04/2026

Phase I/II

Double-blind, randomized, placebo-controlled, study to evaluate the safety and efficacy of HRX215 in participants after major hepatectomy, preceded by two open pilot parts in participants after minor and after major hepatectomy due to colon carcinoma metastases

2025-523630-59-00colon carcinoma metastases

HepaRegeniX GmbH

Neoplasms

France, Spain, Germany

20/04/2026

Phase I/II

An open-label, multi-center, phase I/II study of GVV858 as a single agent and in combination with endocrine therapy in patients with advanced hormone receptor positive, HER2-negative breast cancer and other advanced solid tumors

2025-521911-38-00Advanced HR+/HER- breast cancer

DrugsLeuprorelin acetate·Goserelin·Letrozole·Fulvestrant

Novartis Pharma AG

Neoplasms

Italy, Germany, France, Czechia, Denmark, Spain

16/04/2026

Phase I/II

Multicentre, open-label, phase 1/2 study of LB-208, selective antagonist of the serotonin 5-hydroxytryptamine receptor 1B (HTR1B), in adults with relapse or refractory (r/r) acute myeloid leukaemia (AML) and r/r higher-risk (HR) myelodysplastic syndrome (MDS)

2025-523396-38-00Relapse or refractory (r/r) acute myeloid leukaemia (AML) a…

Aop Orphan Pharmaceuticals GmbH

Neoplasms

Spain

15/04/2026

Phase I/II

A two-part study: open label, dose escalation phase aimed to evaluate the safety and tolerability of two different doses of allogeneic fibroblasts for the treatment of chronic refractory wounds and identifying the best dose for subsequent cohort expansion phase aimed to assess efficacy and confirm safety and tolerability

2025-522647-17-00Refractory wounds

Hmg Biologics S.r.l.

Skin and Connective Tissue Diseases

Italy

15/04/2026

Phase I/II

A Phase 1/2 open-label, multicenter study of oral GSK5460025 alone or in combination with other anti-cancer agents in adult participants with Mismatch Repair-deficient (dMMR) or Microsatellite Instability-High (MSI-H) solid tumors.

2025-522318-21-00Neoplasms, Colorectal

Glaxosmithkline Research & Development Limited

Neoplasms

Italy, Denmark, Spain, Sweden, Netherlands, France

14/04/2026

Phase I/II

Phase 1/2A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients with Advanced Solid Tumors

2025-524111-37-00advanced solid tumors

Ottimo Pharma Limited

Neoplasms

Ireland, Spain, Portugal

14/04/2026

Phase I/II

Research on two creams (Monobenzon / Imiquimod) together with the standard treatment for advanced or metastatic melanoma (ImMI).

2024-520052-19-04Malignant Melanoma

Amsterdam UMC Stichting

Therapeutics

Netherlands

13/04/2026

Phase I/II

An Open-label, Multicenter, Two Part, Ascending Dose Followed by a Controlled Trial to Assess the Safety and Efficacy of a Subretinal Administration of AAVB-039 in Participants with Stargardt Disease (STGD1) (CELESTE)

2025-522207-15-01Stargardt Disease (STGD1)

Aavantgarde Bio S.r.l.

Eye Diseases

Belgium, Italy, Netherlands, Norway

10/04/2026

Phase I/II

A Phase 1/2a, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Advanced Solid Malignancies

2025-523547-35-00Advanced Solid Tumor Malignancies

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Spain

09/04/2026

Phase I/II

C6461020 - An Interventional Open-Label Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of PF-08634404 in combination with Different Anticancer Agents in Participants with Advanced Solid Tumors

2025-523526-40-00Advanced Solid Tumors

Pfizer Inc.

Neoplasms

Italy, Spain, France, Germany

09/04/2026

Phase I/II

C6461013 - An Interventional Open-label Phase 1b/2 Study to Evaluate Safety, Pharmacokinetics, and Preliminary Efficacy of PF-08634404 as Monotherapy and Combination Therapy in Adult Participants With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma

2025-523525-17-00Unresectable Locally Advanced or Metastatic Hepatocellular …

DrugsPF-08634404·Ipilimumab

Pfizer Inc.

Neoplasms

Spain, Italy, Germany, France

09/04/2026

Phase I/II

Phase 1/2 Investigation Of Novel Experimental Regimen in Amyotrophic Lateral Sclerosis (PIONEER-ALS): An Open-Label, Uncontrolled, Multicenter Study to Assess the Safety and Tolerability of Two Doses of VTx-002.

2025-522697-37-00Amyotrophic Lateral Sclerosis

VectorY Therapeutics B.V.

Nervous System Diseases

Netherlands, Belgium, Spain

31/03/2026

Phase I/II

CELL-BASED IMMUNOTHERAPY FOR TREATMENT OF TRIPLE NEGATIVE BREAST CANCER STAGES II AND III

2023-506019-16-03TRIPLE NEGATIVE BREAST CANCER

Celica d.o.o.

Neoplasms

Slovenia

31/03/2026

Phase I/II

A Phase Ib/II Open-Label, Multicentre Platform Study Evaluating Novel Combinations in Participants with Advanced or Metastatic Non-Small Cell Lung Cancer (ALTAIR)

2024-519786-22-01metastatic non-small cell lung cancer (NSCLC)

DrugsRamucirumab·Rilvegostomig

AstraZeneca AB

Neoplasms

Germany, Spain, France, Poland, Belgium, Netherlands, Italy

30/03/2026

Phase I/II

A Phase I/II, Modular, Open-Label, Multi-Centre Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD9750 as Monotherapy and in Combination with Other Anticancer Agents in Participants with Metastatic Prostate Cancer (ANDROMEDA)

2024-516976-14-00Metastatic Prostate Cancer

AstraZeneca AB

Male Urogenital Diseases

Netherlands, Spain

30/03/2026

Phase I/II

The headache- and migraine-inducing effects of pitolisant in women with migraine without aura

2026-525521-20-00Migraine without aura

DrugsSumatriptan·Pitolisant·Ibuprofen

Syddansk Universitet (University of Southern Denmark)

Nervous System Diseases

Denmark

26/03/2026

Phase I/II

FIDES: Focused Ultrasound-mediated Blood-Brain Barrier Opening In Pontine Diffuse Midline Glioma (DMG) to Enhance Systemic Therapy with Temozolomide – an exploratory pilot and feasibility trial

2025-520814-78-00Diffuse Midline Glioma, H3K27-altered

DrugTemozolomide

Universitair Medisch Centrum Utrecht

Nervous System Diseases

Netherlands

23/03/2026

Phase I/II

Changes in the tumour microenvironment after intravenous or intradermal administration of anti-CTLA-4 in combination with anti-PD1 treatment in patients with melanoma

2024-516545-39-01unresectable stage III – IV melanoma

DrugIpilimumab

Stichting Amsterdam UMC

Neoplasms

Netherlands

18/03/2026

Phase I/II

A Phase 1/2 Trial of RPTR-1-201, a T Cell Receptor Bispecific Therapy, in Advanced Solid Tumors

2025-524010-28-00Advanced Solid Tumor

Repertoire Immune Medicines Inc.

Neoplasms

Spain, Ireland, Portugal, France

17/03/2026

Phase I/II

A Phase Ib/II, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination with Other Anti-Cancer Therapies in Patients with Advanced Solid Tumors

2025-523742-27-00Advanced solid tumors

Medilink Therapeutics (Suzhou) Co. Ltd.

Neoplasms

Poland, Spain, France, Romania, Italy, Belgium, Hungary, Germany

17/03/2026

Phase I/II

Phase I/II combination umbrella trial in progressive/relapsed/refractory pediatric low-grade glioma (pLGG) (EPILOGUE)

2024-516896-34-00progressive/relapsed/refractory pediatric low-grade glioma …

DrugTovorafenib

Universitaetsklinikum Heidelberg AöR

Nervous System Diseases

Denmark, Czechia, Austria, Sweden, Germany

17/03/2026

Phase I/II

IL-1β blockade to prevent Immunothrombosis in recipients of a Pancreatic Organ (ILIPO)

2025-524834-24-00diabetic patients pancreatic transplant

Centre Hospitalier Universitaire De Nantes

Immune System Diseases

France

12/03/2026

Phase I/II

HOVON 178 WM: A prospective phase I/II trial of epcoritamab in patients with relapsed or refractory Waldenstrom’s macroglobulinemia

2025-522295-91-00relapsed or refractory Waldenstrom’s macroglobulinemia

DrugEpcoritamab

Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

Neoplasms

Denmark, Belgium, Netherlands

10/03/2026

Phase I/II

Late immunity following single immunization with GA2 sporozoites (GACHA)

2025-524045-27-00Falciparum malaria

Leids Universitair Medisch Centrum (LUMC)

Parasitic Diseases

Netherlands

09/03/2026

Phase I/II

CAT-01

2024-517594-24-01Cervical carcinoma

Karolinska Institutet

Neoplasms

Sweden

09/03/2026

Phase I/II

Allogeneic adipose tissue-derived Mesenchymal stromal cells for the treatment of chronic-active antibody mediated rejection in Kidney transplant recipients

2024-510723-18-00Chronic active antibody mediated rejection

Region Midtjylland

Immune System Diseases

Denmark

09/03/2026

Phase I/II

An Adaptive Dose Escalation and Expansion Basket Trial to Explore the Safety, Pharmacology, and Clinical Activity of TGD001 in Immune-Mediated Thrombotic Thrombocytopenic Purpura (iTTP) and Other Thrombotic Microangiopathies

2025-523802-34-00Immune-Mediated Thrombotic Thrombocytopenic Purpura, Thromb…

TargED Biopharmaceuticals B.V.

Hemic and Lymphatic Diseases

Germany, France, Italy, Spain

06/03/2026

Phase I/II

A Phase 1/2a Study of REGN7041 (anti-CD3 monoclonal antibody) in patients with Active Noninfectious Uveitis affecting the Posterior Segment

2025-521713-57-00Noninfectious Uveitis

Regeneron Pharmaceuticals Inc.

Eye Diseases

France

05/03/2026

Phase I/II

A phase Ib/II open-label, multi-center study of the DNA protein kinase inhibitor AMO959 with lutetium (177Lu) vipivotide tetraxetan (AAA617) in combination with an androgen receptor pathway inhibitor (ARPI) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC)

2025-521859-23-00PSMA-positive mCRPC with prior exposure to at least one pri…

Novartis Pharma AG

Neoplasms

Germany, France, Spain, Italy

05/03/2026

Phase I/II

Protocol Title: KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

2024-512248-47-00Non-small Cell Lung Cancer (NSCLC)

DrugsCalderasib·Patritumab deruxtecan·Sacituzumab tirumotecan·Cetuximab

Merck Sharp & Dohme LLC

Neoplasms

Italy, Germany, Greece, Poland, Hungary, Spain

04/03/2026

Phase I/II

A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD9793, a T cell-engaging Antibody Targeting Glypican-3 (GPC3) in Adult Participants with Advanced or Metastatic Solid Tumours (RHEA-1)

2024-516698-56-00Hepatocellular Carcinoma

AstraZeneca AB

Neoplasms

Spain

03/03/2026

Phase I/II

A Modular, Open Label, Dose Finding Phase 1/2 Clinical Trial in Patients with Solid Tumours to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PTT-4256 (RAISIC-1: Relief of Acidic Immune Suppression In Cancer)

2025-522944-41-00Solid Tumours

DrugNivolumab

Pathios Therapeutics Limited

Not possible to specify

France, Spain

27/02/2026

Phase I/II

A Phase Ib/II, multi-site, open-label, two-part trial to evaluate the efficacy, safety, pharmacokinetics, and recommended combination dose of BNT324 with BNT327 in participants with advanced lung cancer

2024-520238-31-01Advanced Lung Cancer

BioNTech SE

Neoplasms

Spain, France, Italy, Poland

24/02/2026

Phase I/II

A Phase 1/2, Global, Open-Label, Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study

2022-502911-12-00Propionic Acidemia

Moderna Inc.

Nutritional and Metabolic Diseases

Spain, Netherlands, France

23/02/2026

Phase I/II

A Phase 1 Study of Fentanyl Vaccine

2025-524277-16-00Opioid induced respiratory depression

ARMR Sciences Inc.

Environment and Public Health

Netherlands

23/02/2026

Phase I/II

A Multi-Center, Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Adults with Chronic Hepatitis B

2025-523619-12-00Chronic Hepatitis B

Nchroma Bio Inc.

Virus Diseases

France

20/02/2026

Phase I/II

A Single-center, Prospective, Non-randomized, Open, Pilot Study Evaluating the Safety and Performance of the Extroducer® Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients with Unresectable Locally Advanced Pancreatic Cancer

2025-524733-11-00Unresectable Locally Advanced Pancreatic Cancer

Smartwise Sweden AB

Digestive System Diseases

Sweden

20/02/2026

Phase I/II

A phase 1/2a, first-in-human, open-label, dose-escalating study with a safety expansion cohort to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumour activity of TAX2 in patients with relapsed/refractory advanced/metastatic solid tumours

2025-521164-36-00Patients with relapsed/refractory advanced/metastatic ovari…

Apmonia Therapeutics

Neoplasms

Belgium, France

19/02/2026

Phase I/II

Phase 1/2, Open Label, Sequential Cohort Study of a Single Intracranial Dose of rAAVOlig001-ASPA Gene Therapy for Treatment of Children with Typical Canavan Disease

2024-519412-13-00Canavan Disease, Canavan disease

Myrtelle Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

France

18/02/2026

Phase I/II

A Phase 1b/2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate A) the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of IM-101 in Adult Participants with Generalized Myasthenia Gravis, and B) the Efficacy and Safety of Treatment of IM-101 in Adult Participants with Generalized Myasthenia Gravis and Ocular Myasthenia Gravis

2025-522406-20-00Generalized Myasthenia Gravis and Ocular Myasthenia Gravis

Immunabs Inc.

Nervous System Diseases

Bulgaria, Poland, Spain, Italy

18/02/2026

Phase I/II

A Phase 1/2, Multicenter, Open-Label, Multi-Cohort, First-in Human Trial of DS3790a, a DXd-ADC targeting CD37, for Hematological Malignancies.

2025-522595-87-00Hematological Malignancies

Daiichi Sankyo Inc.

Neoplasms

France, Italy

16/02/2026

Phase I/II

A Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of Administration of Subcutaneous (SC) Blinatumomab in Pediatric Participants with Relapsed/Refractory (R/R) and Minimal Residual Disease Positive (MRD+) B Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)

2025-521671-31-00Relapsed/Refractory (R/R) and Minimal Residual Disease Posi…

Amgen Inc.

Neoplasms

France, Netherlands, Italy

13/02/2026

Phase I/II

A multicenter, Phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics and preliminary clinical activity of TUB-040, in combination with standard ovarian cancer drugs in patients with high-grade epithelial serous or endometrioid epithelial ovarian cancer (OC) (NAPISTAR 1-02)

2025-524691-33-00High-grade epithelial serous or endometrioid epithelial ova…

Gilead Sciences Inc.

Female Urogenital Diseases and Pregnancy Complications

Belgium

12/02/2026

Phase I/II

A Phase 1/2, Randomized, Double-blind, Placebo-controlled 2-part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-4324 in Overweight to Obese Adult Healthy Volunteers and Multiple Dose ALN-4324 in Overweight to Obese Patients With Type 2 Diabetes Mellitus (T2DM)

2024-519005-35-00Type 2 Diabetes Mellitus

Alnylam Pharmaceuticals Inc.

Hormonal diseases

Germany, Poland

10/02/2026

Phase I/II

A Phase 1/2, Multicenter, Open-label, Dose Escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ASP2957 in Male Participants with Invasive Ventilator-dependent X-linked Myotubular Myopathy

2025-523213-29-00X-linked myotubular myopathy

DrugASP2957

Astellas Gene Therapies Inc.

Musculoskeletal Diseases

France

09/02/2026

Phase I/II

Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta.

2025-522729-36-00Chronic Hepatitis Delta.

Gilead Sciences Inc.

Virus Diseases

Italy, Romania, Germany, Bulgaria

09/02/2026

Phase I/II

A Single Arm, Open Label, Phase 1/2 Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients with Sickle Cell Disease

2024-519881-32-00Sickle Cell Disease

Novo Nordisk A/S

Hemic and Lymphatic Diseases

France

06/02/2026

Phase I/II

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents in Combination With Enfortumab Vedotin Plus Pembrolizumab as First-Line Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma: KEYMAKER-U04–Substudy 04D

2025-522253-19-00Urothelial carcinoma

Merck Sharp & Dohme LLC

Neoplasms

Netherlands, France, Spain

03/02/2026

Phase I/II

An open label, phase I/II study investigating the safety and efficacy of a CD3/CD20 bispecific T-cell engager therapy in patients with active, treatment refractory, ANCA-IgG-positive associated vasculitis. The RENEWAL study

2025-522853-21-01Active, treatment refractory, ANCA-IgG-positive associated …

Fraunhofer Institute For Translational Medicine And Pharmacology ITMP

Immune System Diseases

Germany

30/01/2026

Phase I/II

First-in-human, Open-label, Multi-site, Phase I/IIa, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT329 in Participants With Advanced Solid Tumors Known to Express CA19-9

2025-522613-26-00Advanced Solid Cancers

BioNTech SE

Neoplasms

Spain, Germany

29/01/2026

Phase I/II

A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-DM1 in Subjects With Type 1 Myotonic Dystrophy Who are ≥18 to ≤65 Years

2024-513579-42-00Type 1 Myotonic Dystrophy

Sarepta Therapeutics Inc.

Nervous System Diseases

Spain, Germany, Belgium, Italy

29/01/2026

Phase I/II

Guttmann NeuroRecovery – Feasibility, safety and efficacy of intrathecal Wharton's jelly-derived mesenchymal stem cells and transcutaneous spinal cord stimulation in the rehabilitation of chronic spinal cord injuries: a pilot study

2025-521877-14-00Traumatic spinal cord injury

Fundacio Institut Guttmann

Nervous System Diseases

Spain

28/01/2026

Phase I/II

A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of Etentamig Monotherapy or Etentamig Combinations in Subjects with Multiple Myeloma

2024-515770-27-00Multiple Myeloma

AbbVie Deutschland GmbH & Co. KG

Neoplasms

Norway

27/01/2026

Phase I/II

Evaluation of a [68Ga] Ga-HER2 single domain antibody PET/CT for predicting pathological complete response (pCR) after neoadjuvant chemotherapy (NACT) in HER2-positive early breast cancer

2025-523286-23-00Breast Cancer

Centre Henri Becquerel

Not possible to specify

France

26/01/2026

Phase I/II

A First-in-Human, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intrathecally Administered LTX-002 in Adult Participants with Amyotrophic Lateral Sclerosis

2025-522039-33-00Amyotrophic Lateral Sclerosis

Leal Therapeutics Inc.

Nervous System Diseases

Sweden, Italy, Germany, Netherlands

23/01/2026

Phase I/II

A PHASE 1/1B STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND IMMUNOGENICITY OF SINGLE AND MULTIPLE ASCENDING DOSES OF BCX17725 IN HEALTHY PARTICIPANTS AND MULTIPLE DOSES OF BCX17725 IN PARTICIPANTS WITH NETHERTON SYNDROME

2025-521973-16-00Netherton Syndrome

Biocryst Pharmaceuticals Inc.

Skin and Connective Tissue Diseases

France, Netherlands, Germany

20/01/2026

Phase I/II

AdaptNK –Cell Therapy for High-risk Myeloid Disease

2025-521962-83-00Relapsed and/or refractory AML or MDS

Karolinska Institutet

Hemic and Lymphatic Diseases

Sweden

19/01/2026

Phase I/II

DREPAMIR - A Phase 1/2 Open Label Cohort Comparative Study Evaluating the Efficacy and the safety of Gene Therapy of the Sickle Cell Disease by Transplantation of an Autologous CD34+ enriched cell fraction that contains autologous CD34+ cells transduced ex vivo by the bifunctional βAS3m/miR7m lentiviral vector expressing the βAS3m and a micro-RNA (miRNA) targeting specifically the endogenous βS-globin mRNA in Patients with Sickle Cell Disease (SCD)

2025-521257-17-00SCD severe patients

Assistance Publique Hopitaux De Paris

Hemic and Lymphatic Diseases

France

16/01/2026

Phase I/II

A Phase 1/2 dose escalation trial with administration schedule exploration evaluating single agent TD001, a PSMA-targeted antibody-drug conjugate, in patients with PSMA-expressing metastatic castration-resistant prostate cancer

2025-523273-41-00Metastatic castration-resistant prostate cancer

T.O.A.D. Oncology S.A.

Neoplasms

Spain, France

16/01/2026

Phase I/II

A Phase 1/2, multicentre, open-label clinical trial of DT-7012 as monotherapy and in combination with an immune checkpoint inhibitor in participants with selected advanced solid tumours

2025-523758-15-00Cancer

Domain Therapeutics Australia Pty Limited

Neoplasms

France

14/01/2026

Phase I/II

An Open-Label, Multicenter, Phase 1 Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of TLN-372 as a Single Agent and in Combination with Other Anti-Tumor Agents, in Patients with Advanced KRAS Mutant Solid Tumors

2025-523086-22-00Locally advanced or metastatic solid tumors

Treeline Biosciences Inc.

Neoplasms

Spain

07/01/2026

Phase I/II

Dual wavelength fluorescence imaging using fluorescently labelled adalimumab and risankizumab for visualizing drug targeting in Inflammatory Bowel Diseases (VOYAGER)

2025-521420-30-00Inflammatory Bowel Disease (IBD)

Universitair Medisch Centrum Groningen

Digestive System Diseases

Netherlands

06/01/2026

Phase I/II

Single-center phase I/IIa study of infusion of autologous peripheral blood T cells expanded and genetically modified by Sleeping Beauty family transposons to express a chimeric antigen receptor with anti-CD19 specificity conjugated with the 4-1BB costimulatory region and CD3z and huEGFRt signal transmission (TranspoCART19) in patients with CD19+ acute lymphoblastic leukemia resistant or refractory to treatment

2025-522673-11-00refractory or resistant CD19+ acute lymphoblastic leukemia

Clinica Universidad De Navarra

Hemic and Lymphatic Diseases

Spain

02/01/2026

Phase I/II

Inhibiting the anti-apoptotic factor, BCL-2, at the time of ART initiation to promote apoptosis of HIV-infected cells and restrict the seeding of the HIV reservoir: An investigator-initiated randomised, controlled, open-label clinical trial (The INITIATE Study)

2025-521841-26-00HIV-1 infection

Region Midtjylland

Virus Diseases

Denmark, Spain

02/01/2026

Phase I/II

A Clinical study of MK-4716 in people with certain solid tumors (MK-4716-001)

2025-522495-84-00Cancer – Solid Tumors : 1L NSCLC and all other advanced or …

Merck Sharp & Dohme LLC

Neoplasms

Spain

23/12/2025

Phase I/II

An Open-Label, Phase I/II First-in-Human, Dose Escalation, Dose Optimisation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 as Single Agent in Adult Participants with Locally Advanced or Metastatic Solid Tumours.

2025-522139-33-00Advanced or metastatic solid tumours

Ipsen Pharma

Neoplasms

France, Spain

23/12/2025

Phase I/II

Phase 1b/2 Dose-Ranging Study of the Safety, PK, PD & Efficacy of the Activin Signaling Inhibitor HS235 vs placebo added to background therapy in PAH (SEASIde)

2025-523010-89-00Pulmonary arterial hypertension

35Pharma Inc.

Cardiovascular Diseases

Hungary, Spain, Poland, Germany, Czechia

23/12/2025

Phase I/II

Phase 1/2 Study of Intravesical MK-3120 in BCG-Naïve or BCG-Exposed High-Risk Non-muscle Invasive Bladder Cancer

2025-520467-40-00High-risk non-muscle invasive bladder cancer (NMIBC) with c…

DrugMK-3120

Merck Sharp & Dohme LLC

Neoplasms

Belgium, Greece, Austria, Spain, Norway, Netherlands, Italy, France

22/12/2025

Phase I/II

SPRAYDYE-Trial - A phase I/II study to assess the efficacy, safety and tolerability of topically applied 6qc-ICG, a cathepsin-activatable fluorescent probe, for real-time intraoperative resection margin assessment in breast conserving surgery

2025-523166-24-00Breast cancer

Leids Universitair Medisch Centrum (LUMC)

Neoplasms

Netherlands

22/12/2025

Phase I/II

Open-labelled, single-centre investigation of safety and tolerability of multiple ascending doses of nebulised SS0331 in healthy participants followed by investigation of preliminary efficacy of nebulised SS0331 in airway-infected patients with chronic airway infections

2025-523875-48-00Chronic airway infections

Softox Solutions AS

Virus Diseases

Denmark

19/12/2025

Phase I/II

Phase 1/2 multicenter, two-arms, open-label, dose-escalation study of IDP-121 in combination with chemotherapy in patients with relapsed small cell lung cancer (SCLC) (MYCrocytic)

2025-521902-17-00Unresectable/metastatic Small cell Lung Cancer (SCLC)

Idp Discovery Pharma S.L.

Neoplasms

Spain

18/12/2025

Phase I/II

TulmiSTAR-02: A two-part Phase I dose escalation study of tulmimetostat (DZR123) in combination with darolutamide or abiraterone followed by open-label, randomized, Phase II dose expansion study to assess the safety and efficacy of tulmimetostat in combination with darolutamide versus darolutamide alone in patients with metastatic hormone-sensitive prostate cancer

2025-521873-15-00Metastatic hormone-sensitive prostate cancer

Novartis Pharma AG

Neoplasms

Hungary, Spain, Italy, Germany, France

18/12/2025

Phase I/II

Sodium selenite in patients with advanced carcinoma: A phase I/II study with 99 hours of continuous selenite treatment followed by chemotherapy

2025-522798-13-00Advanced carcinoma

Karolinska University Hospital

Neoplasms

Sweden

17/12/2025

Phase I/II

A PHASE I/II STUDY TO INVESTIGATE THE SAFETY AND FEASIBILITY OF POINT-OF-CARE HUMAN-CD19 TARGETING CAR T-CELLS IN PAEDIATRIC AND YOUNG ADULT PATIENTS WITH RELAPSED OR REFRACTORY B-CELL MALIGNANCIES (PACMAN)

2023-507597-40-00B-cell precursor ALL, B-cell Non Hodgkin Lymphoma

Prinses Maxima Centrum voor Kinderoncologie B.V.

Neoplasms

Netherlands

16/12/2025

Phase I/II

An Open-label, Phase I/II First in Human, Dose Escalation, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Participants With Locally Advanced or Metastatic Solid Tumours Who Have Progressed on or After Immune Checkpoint Inhibitor Therapies

2025-522184-15-00Advanced Solid Tumor, Metastatic Solid Tumor

Ipsen Pharma

Neoplasms

Spain, France

16/12/2025

Phase I/II

Phase 1b/2 Trial of OMTX705, an Anti-Fibroblast Activation Protein Antibody-Drug Conjugate, in Combination with Carboplatin, Pemetrexed and Tislelizumab in Patients with Advanced/Metastatic Non-squamous Non-Small Cell Lung Cancer

2025-521989-95-00Advanced/Metastatic Non-squamous Non-Small Cell Lung Cancer

DrugsOMTX705·Tislelizumab

Oncomatryx Biopharma S.L.

Neoplasms

Spain

12/12/2025

Phase I/II

A Modular Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0516 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Metastatic Prostate Cancer.

2024-520026-11-00Metastatic Prostate Cancer

AstraZeneca AB

Neoplasms

Italy, Spain, Poland

12/12/2025

Phase I/II

An Open-label, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumour Activity of WEF-001 in participants with Advanced KRAS- Mutant Solid Tumours.

2024-518644-21-01Advanced KRAS- Mutant Solid Tumours

Auricula Biosciences Inc.

Neoplasms

Spain

09/12/2025

Phase I/II

A Modular Phase I/II, Open-label, Multi-Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants with Advanced Haematologic Malignancies with KMT2Ar, NPM1m, or Other Genotypes Associated with HOX Overexpression

2025-521299-76-00Relapsed or refractory acute leukaemia or Myelodysplastic S…

AstraZeneca AB

Neoplasms

Germany, Italy, Denmark

08/12/2025

Phase I/II

Clinical Application of the Androgen Receptor Inhibitor Darolutamide to Upregulate the Prostate-Specific Membrane Antigen (PSMA) Protein Expression in Patients with Hormone Sensitive Prostate Cancer. - The DARO-flare Trial -

2025-520482-52-03Prostate cancer

DrugDarolutamide

Amsterdam UMC Stichting

Diagnosis

Netherlands

04/12/2025

Phase I/II

OVACURE-2: Adoptive T cell therapy plus low dose IL-2 (IL-2ld) as first line neoadjuvant therapy in patients with stage III/IV ovarian cancer

2025-522659-24-00Ovarian carcinoma

Leids Universitair Medisch Centrum (LUMC)

Neoplasms

Netherlands

03/12/2025

Phase I/II

A Phase Ib/II, multi-site, open-label, dose finding trial to evaluate the safety, efficacy, and pharmacokinetics of BNT326 in combination with BNT327 in participants with advanced non-small cell lung cancer (NSCLC)

2024-519344-32-00Non-small Cell Lung Cancer

BioNTech SE

Neoplasms

Poland, Germany, Italy, Spain

02/12/2025

Phase I/II

TulmiSTAR-01: A two-part, Phase I dose escalation and expansion followed by a randomized, open-label multicenter, Phase II study to assess the safety and efficacy of the combination of tulmimetostat (DZR123) and JSB462 (luxdegalutamide) vs standard of care in patients with progressive metastatic castrate resistant prostate cancer

2025-521880-10-00Metastatic castrate resistant prostate cancer (mCRPC)

Novartis Pharma AG

Neoplasms

Italy, Germany, Poland, France, Denmark, Spain

01/12/2025

Phase I/II

An open label, phase I/II study investigating the safety and efficacy of the bispecific T-cell engaging antibody cizutamig (BCMAxCD3) in patients with immune-mediated inflammatory diseases – the SPLENDID Trial

2025-522857-20-00Severe, treatment refractory primary Sjögren’s disease (pSj…

Fraunhofer Institute For Translational Medicine And Pharmacology ITMP

Immune System Diseases

Germany

28/11/2025

Phase I/II

InsigHHT: A Phase 1/2, Randomized, Double-blind, Placebo-controlled, 2 part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-6400 in Adult Healthy Volunteers and Multiple Dose ALN 6400 in Adult Patients with Hereditary Hemorrhagic Telangiectasia (HHT)

2025-522510-23-00Hereditary Hemorrhagic Telangiectasia (HHT)

Alnylam Pharmaceuticals Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

France, Spain, Germany

26/11/2025

Phase I/II

A Phase Ib/ II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination with Giredestrant in Comparison with Abemaciclib and Giredestrant in Participants with Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer who Have Previously Progressed During or After a CDK4/6 Inhibitor

2025-521128-31-00Locally Advanced or Metastatic Estrogen Receptor-Positive, …

Genentech Inc.

Neoplasms

Spain, Italy, France, Germany

26/11/2025

Phase I/II

A modular Phase I/II, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of AZD4512 monotherapy or in combination with anticancer agent(s) in participants with Acute Lymphoblastic Leukemia

2025-522372-93-00B-cell acute lymphoblastic leukemia (B-ALL)

AstraZeneca AB

Hemic and Lymphatic Diseases

Spain

24/11/2025

Phase I/II

A Phase 1/2 Dose Escalation Study of CRN09682 With an Expansion Phase in Participants with Progressive Metastatic Somatostatin Receptor Type 2 (SST2)-Expressing Neuroendocrine Neoplasms (NENs) and Other SST2-Expressing Solid Tumors

2025-521672-60-00Metastatic or locally advanced SST2-positive neuroendocrine…

Crinetics Pharmaceuticals Inc.

Neoplasms

Spain, France, Germany, Italy

21/11/2025

Phase I/II

A Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5764227 in combination with Standard of Care (SoC) or other agents in Participants with Advanced Solid Tumors

2025-522274-37-00Neoplasms

Glaxosmithkline Research & Development Limited

Neoplasms

Spain

21/11/2025

Phase I/II

An open-label, non-randomized, extension study to further investigate the long-term efficacy, safety, and tolerability of Guanabenz in patients with early childhood onset vanishing white matter (VWM)

2024-518834-95-02Vanishing white matter

Amsterdam UMC Stichting

Nervous System Diseases

Netherlands

21/11/2025

Phase I/II

A multi-center, open-label Phase 1/2 study to evaluate the safety, efficacy, PK and PD of ONA-255 in study participants with advanced cancer

2025-522233-62-00Advanced cancer; breast cancer; metastatic gastric / gastro…

Ona Therapeutics S.L.

Neoplasms

Spain

19/11/2025

Phase I/II

A Randomised, Placebo-Controlled, Double-Blind, Single-Ascending Dose and Multiple-Ascending Dose First-In-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered ALE1 With or Without Food in Healthy Adult Participants and Adult Patients With Hypophosphatasia

2025-522378-36-00Hypophosphatasia

Alesta Therapeutics B.V.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Germany

19/11/2025

Phase I/II

Phase 1/2 Study of PYX-201 in Combination with Pembrolizumab in Advanced Solid Tumors

2025-521828-30-00Advanced Solid Tumors

Pyxis Oncology Inc.

Neoplasms

France, Spain, Poland

19/11/2025

Phase I/II

A Modular Phase I/II Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Efficacy of AZD4512 Monotherapy or in Combination With Other Anticancer Agent(s), in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL) (Lumi-NHL)

2025-522371-29-00Non-Hodgkin lymphoma (NHL)

AstraZeneca AB

Hemic and Lymphatic Diseases

Italy

18/11/2025

Phase I/II

C5731006 - A PHASE 1B/2, OPEN-LABEL, MULTICOHORT STUDY OF DISITAMAB VEDOTIN IN ADULTS WITH HER2 EXPRESSING ADVANCED BREAST CANCER

2025-521003-52-00HER2 Expressing Advanced Breast Cancer

Pfizer Inc.

Neoplasms

Germany, Spain, Italy

18/11/2025

Phase I/II

A phase I/II study of CAR-T cells in AutoiMmune disease resistant to B cell Abrogation - CARAMBA

2025-521530-28-00Progressive systemic autoimmune disease resistant to B cell…

Universitaetsklinikum Erlangen AöR

Immune System Diseases

Germany

17/11/2025

Phase I/II

A Phase I/II, Open-Label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients with Selected Advanced or Metastatic CLDN1+ Solid Tumors

2025-521441-24-00Advanced or Metastatic Solid Tumors

Alentis Therapeutics AG

Neoplasms

Spain, France, Netherlands, Italy

12/11/2025

Phase I/II

A Phase I/II, multi-site, open-label, two-part trial to evaluate the efficacy, safety, and pharmacokinetics of BNT323 in combination with BNT327 in participants with advanced breast cancer

2024-517979-20-00Advanced Breast Cancer Metastatic Breast Cancer

BioNTech SE

Neoplasms

Italy, Spain, France

11/11/2025

Phase I/II

A Phase 1/2a, First-in-human, Open label Study of BMS-986517 as Monotherapy or Combination Therapy in Adult Participants with Advanced Solid Tumors

2025-522203-23-00Advanced Solid Tumors

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Denmark, Spain

07/11/2025

Phase I/II

(22931) A first-in-human study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and preliminary clinical activity of BAY 3713372, a novel 2nd generation PRMT5 inhibitor, in participants with MTAP-deleted solid tumors.

2025-520623-24-00MTAP-deleted Solid Tumors

Bayer AG

Neoplasms

Belgium, Sweden, Denmark, Italy, Spain, Netherlands, Czechia

04/11/2025

Phase I/II

A Phase 1/2 First-Time-in-Human, open-label, multicenter, dose escalation and expansion study of GSK5458514 PSMA targeting T cell engager alone or in combination with other anti-cancer agents in adult participants with metastatic castration-resistant prostate cancer (mCRPC)

2025-521581-10-00Neoplasms, Prostate

Glaxosmithkline Research & Development Limited

Neoplasms

France, Spain

03/11/2025

Phase I/II

A Multicenter First-in-human Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of the 5T4 Antibody-Drug Conjugate TUB-030 in Patients with Advanced Solid Tumors (5-STAR 1-01)

2025-522517-35-00Patients with advanced/metastatic tumors with head and neck…

Gilead Sciences Inc.

Neoplasms

France, Spain, Romania

03/11/2025

Phase I/II

Longitudinal study with positron emission tomography using [18F]PI-2620 in primary tauopathies. Proof-of-concept study

2025-522826-11-00Corticobasal syndrome (CBS), Progressive supranuclear palsy…

ZRO Imaging AB

Nervous System Diseases

Spain

03/11/2025

Phase I/II

A Phase 1b/2a, Open-Label, Sequential-Cohort, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Effectiveness of Budoprutug (TNT119) in Subjects with Immune Thrombocytopenia (ITP)

2024-519745-30-01Immune Thrombocytopenia (ITP)

Climb Bio Inc.

Hemic and Lymphatic Diseases

Greece, Spain, Bulgaria

03/11/2025

Phase I/II

GAIN-CTNNB1: A Phase I/II open-label trial to evaluate the safety, tolerability, and preliminary efficacy of a single intracerebroventricular administration of an AAV9-based gene replacement therapy in paediatric patients with CTNNB1 syndrome

2025-522719-40-00CTNNB1 syndrome

Fundacija CTNNB1 Ustanova Za Raziskave Na Podrocju Genske Terapije

Nervous System Diseases

Slovenia

03/11/2025

Phase I/II

A Phase 1/2 First-Time-in-Human, open-label, multicenter, dose escalation and expansion study of the oral DNA Polymerase Theta Inhibitor (POLQi) GSK4524101 and the PARP inhibitor (PARPi) niraparib in adult participants with solid tumors.

2024-520197-36-00Neoplasms

Glaxosmithkline Research & Development Limited

Neoplasms

Estonia, Czechia, Spain, Romania, Italy, Denmark, Belgium, Greece

03/11/2025

Phase I/II

A Phase 1b/2a Open-Label Dose-Finding Followed by Randomized, Double-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of TGD001 in Patients with Acute Ischemic Stroke

2025-522455-26-00Acute Ischemic Stroke

TargED Biopharmaceuticals B.V.

Nervous System Diseases

Poland, Germany, Spain

31/10/2025

Phase I/II

The use of [68Ga]Ga-FAPI PET/MRI in assessing disease activity in patients with Graves’ orbitopathy

2025-521163-12-01Graves' Orbitopathy

Drug[68Ga]Ga-FAPI-46

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Immune System Diseases

Netherlands

30/10/2025

Phase I/II

A single-arm, multicenter, open-label, Phase I/II trial of Allo-QuadCAR01-T, an allogeneic CAR-T-cell therapy targeting CD19 and CD20, for the treatment of relapsed or refractory B-cell malignancies

2025-521735-36-00Relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL)…

Avencell Therapeutics Inc.

Neoplasms

Germany

27/10/2025

Phase I/II

A Phase 1b/2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination with Elranatamab in Participants with Relapsed and/or Refractory Multiple Myeloma

2025-522090-11-00Relapsed or Refractory Multiple Myeloma (RRMM)

Celgene Corp.

Neoplasms

Norway, Greece, Germany, Spain

21/10/2025

Phase I/II

A Phase I/II, open-label, adaptive two-part trial to evaluate the safety, efficacy, optimal dose and pharmacokinetics of BNT326 as monotherapy and in combination with cancer immunotherapies in participants with advanced solid tumors

2024-517261-16-00Advanced solid tumors

BioNTech SE

Neoplasms

Belgium, Germany, Spain, Italy

17/10/2025

Phase I/II

A Phase 1/2, Open-Label, Dose Finding Study to Investigate the Safety, Tolerability, and Efficacy of ALXN2350 Gene Therapy in Adult Participants with Symptomatic BAG3 Mutation-Associated Dilated Cardiomyopathy

2024-519674-40-00BAG3 Mutation Associated Dilated Cardiomyopathy

DrugSirolimus

Alexion Pharmaceuticals Inc.

Cardiovascular Diseases

Spain, Italy, Germany

16/10/2025

Cite this view

Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 7 November 2026. https://priyalifescience.com/clinical-trials-europe

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About this register

This register is built from the EU Clinical Trials Information System (CTIS), run by the European Medicines Agency: the single register for every trial authorised under the EU Clinical Trials Regulation (536/2014). CTIS held 12,788 trial records at the last sync on 07 Nov 2026, 03:17 UTC; this register shows the 2,557 most recently authorised of them, a stated recency window rather than the full archive. The list can be downloaded as CSV or JSON.

This page shows the 228 of those trials that match the filters currently applied.

How many clinical trials does CTIS hold?

CTIS held 12,788 trial records at the last sync. Of the 2,557 most recently authorised trials shown in this register, 789 are Phase III, and 228 match the filters currently applied. Trials are counted by authorisation, not by recruitment status, which CTIS does not publish in the same form as ClinicalTrials.gov.

Summary by phase

Trials by phase, 228 trials
Phase	Trials	Share
Phase I/II	228	100%

Most active sponsors

Lead sponsors with the most trials
Lead sponsor	Trials
AstraZeneca AB	9
Glaxosmithkline Research & Development Limited	7
Merck Sharp & Dohme LLC	7
Novartis Pharma AG	7
Bristol-Myers Squibb Services Unlimited Company	6
BioNTech SE	5
Pfizer Inc.	5
Amsterdam UMC Stichting	4
Leids Universitair Medisch Centrum (LUMC)	4
Gilead Sciences Inc.	3

Member states with the most trials

Member states by number of trials with a site there
Member state	Trials
Spain	125
France	93
Germany	73
Italy	65
Netherlands	51
Poland	32
Belgium	30
Denmark	25
Sweden	15
Czechia	10

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Browse trials by member state

Spain (1074) France (933) Germany (893) Italy (777) Poland (614) Netherlands (544) Belgium (453) Czechia (340) Denmark (316) Hungary (255) Greece (237) Bulgaria (217) Romania (217) Austria (216) Sweden (200)

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Browse trials by condition

Advanced solid tumors (23) Atopic Dermatitis (19) Non-Small Cell Lung Cancer (15) Obesity (14) Parkinson’s disease (14) Multiple sclerosis (13) Rheumatoid arthritis (13) Ulcerative Colitis (12) Breast Cancer (11) Prostate Cancer (10)

Listing here is informational and not medical advice; eligibility is determined by each study team. Looking for Irish sites? See the Ireland, UK or USA registers. For approved medicines, see the EMA Approvals Tracker.