Clinical trial register · European Union · CTIS

Clinical Trials in Italy, 2026

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 08 Nov 2026, 03:17 UTC

2557

Shown in this register

most recently authorised

12,788

Total on CTIS

full historical archive

789

Phase III

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Top member states

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

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All 28 states

Trials with a site in Italy

Phase

Study

Lead sponsor

Area

Member states

Decision

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 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

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

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

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 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

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 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 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

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, 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

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

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

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

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

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/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

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

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

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 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

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

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

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

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 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

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

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

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

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

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 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

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 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 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 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

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 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

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

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

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

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

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

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

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 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 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, 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

(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 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 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 8 November 2026. https://priyalifescience.com/clinical-trials-europe/country/italy

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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 08 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 65 of those trials with a site in Italy that also match the filters currently applied.

How many recently authorised EU trials have a site in Italy?

65 of the 2,557 most recently authorised trials in this register list a site in Italy and match the filters applied; 0 of them are Phase III. Trials are counted by authorisation on CTIS, not by recruitment status, which CTIS does not publish in the same form as ClinicalTrials.gov.

Summary by phase

Trials by phase (Italy), 65 trials
Phase	Trials	Share
Phase I/II	65	100%

Most active sponsors

Lead sponsors with the most trials (Italy)
Lead sponsor	Trials
Novartis Pharma AG	6
AstraZeneca AB	5
Merck Sharp & Dohme LLC	5
BioNTech SE	4
Bristol-Myers Squibb Services Unlimited Company	4
Glaxosmithkline Research & Development Limited	3
Pfizer Inc.	3
Institut De Recherches Internationales Servier IRIS	2
Aavantgarde Bio S.r.l.	1
AbbVie Deutschland GmbH & Co. KG	1

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.