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Clinical Trials in Germany / NCT05359445
Active, not recruiting Phase 1

IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor

NCT05359445 · tracked via the Priya Life Science Germany tracker
Sponsor
Immatics Biotechnologies GmbH
Phase
Phase 1
Started
2022-05-19
Last updated
2026-04-30

Condition(s) studied

Refractory CancerRecurrent CancerSolid Tumor, AdultCancer

Investigational drug(s) / intervention(s)

IMA401 (Phase Ia)Pembrolizumab (Phase Ia) →IMA 401 (Phase Ib)

IMA401 (Phase Ia): Intravenous infusions in escalating dose levels

Pembrolizumab (Phase Ia): Intravenous infusions in escalating dose levels for combination of IMA 401 and Pembrolizumab

IMA 401 (Phase Ib): Treatment at recommended dose for extension (RDE)

Study summary

The goal of this clinical trial is to evaluate the safety, tolerability and initial anti-tumor activity of IMA401 as monotherapy or in combination with checkpoint inhibitor in patients with recurrent and/or refractory solid tumors.

Patients' HLA status and expression of the MAGE-A4 and/or MAGE-A8 target in the tumor must be confirmed.

Primary objective:

* To determine the maximum tolerated dose and/or recommended dose for extension for IMA401 as monotherapy and in combination with pembrolizumab

Secondary objectives:

* To characterize the safety and tolerability of IMA401 as monotherapy and in combination with pembrolizumab
* To evaluate initial anti-tumor activity of IMA401 as monotherapy and in combination with pembrolizumab
* To describe the pharmacokinetics of IMA401 as monotherapy and in combination with pembrolizumab

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients must have voluntarily signed a written ICF, be able to understand and comply with clinical trial procedures * Patients ≥ 18 years old * Patients must have pathologically confirmed and documented advanced and/or metastatic NSCLC or HNSCC, other solid tumor may be considered * Confirmed HLA status and IMA401 tumor target MAGE-A4 and/or MAGE-A8 expression * Life expectancy \> 2 months * ECOG Performance Status of 0 to 1 * Measurable disease according to RECIST 1.1 * Adequate baseline hematologic, renal and hepatic function; acceptable coagulation status * Patients must have recurrent and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatments * The patient must have recovered from any side effects of prior therapy to Grade 1 or lower (except for non-clinically significant toxicities; e.g., alopecia, vitiligo) prior to treatment start. As determined by the investigator, the patient may still be eligible if the patient has not fully recovered from Grade ≥ 2 toxicities, in case if these toxicities are not anticipated to further improve (e.g., chronic peripheral neuropathy) and such toxicities are not anticipated to worsen with the IMA401 therapy Exclusion Criteria: * Other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed) * History of hypersensitivity to components of IMA401, CPI treatment or rescue medications, contraindication for pembrolizumab * Patients with prior allogeneic stem cell transplantation or organ transplantation * Patients with autoimmune diseases needing disease-directed treatment * Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results * Positive for HIV or with active hepatitis B or C infection. * Patients with active infection * Systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) received 2 weeks prior to starting trial treatment * Patients with active central nervous system metastases and leptomeningeal metastases

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
Universitaetsklinikum Freiburg, Zentralklinikum, Klinik fuer Innere Medizin I Freiburg im Breisgau Baden-Wurttemberg
Universitaetsklinikum Heidelberg AöR, Nationales Zentrum fuer Tumorkrankheiten Heidelberg Baden-Wurttemberg
Thoraxklinik Heidelberg gGmbH, Studienzentrum Thoraxonkologie Heidelberg Baden-Wurttemberg
Universitaetsklinikum Tuebingen AöR, Comprehensive Cancer Center Tuebingen Tübingen Baden-Wurttemberg
Universitaetsklinikum Ulm AöR, ECTU-Early clinical Trials Unit Universitaetsklinikum Ulm Comprehensive Cancer Center Ulm_CCCU Ulm Baden-Wurttemberg
Universitaetsklinikum Erlangen AöR, Interdisciplinary Clinical Trial Unit with ECTU Erlangen Bavaria
Klinikum rechts der Isar der TU Muenchen AöR, Klinik und Poliklinik fuer Innere Medizin III Munich Bavaria
Klinikum Nuernberg, Klinik fuer Innere Medizin 5, Abteilung Onkologie/Haematologie Nuremberg Bavaria
Universitaetsklinikum Regensburg AöR, Klinik fuer Innere Medizin 3 Regensburg Bavaria
Universitaetsklinikum Wuerzburg AöR, Interdisziplinaeres Studienzentrum mit ECTU Würzburg Bavaria
Goethe Universitaetsklinikum Frankfurt AöR, Medizinische Klinik II Frankfurt am Main Hesse
Medizinische Hochschule Hannover, Klinik fuer Haematologie, Haemostaseologie, Onkologie und Stammzelltransplantation Hanover Lower Saxony
Universitätsklinikum Bonn AöR, Medizinische Klinik IIII Bonn North Rhine-Westphalia
Marien Hospital Duesseldorf GmbH, Klinik fuer Onkologie/Haematologie und Palliativmedizin Düsseldorf North Rhine-Westphalia
Universitaetsklinikum Muenster AöR, Medizinische Klinik A Münster North Rhine-Westphalia
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, III. Medizinische Klinik Mainz Rhineland-Palatinate
Klinikum Chemnitz gGmbH, Klinik für Innere Medizin III Chemnitz Saxony
Universitaetsklinikum C. - G. - Carus Dresden, Technische Universitaet Dresden AöR, NCT/UCC Early Clinical Trial Unit Dresden Saxony
Universitaet Leipzig, Universitaeres Krebszentrum Leipzig (UCCL) Leipzig Saxony
Universitaetsklinikum Schleswig- Holstein, Campus Kiel, Medizinische Klinik II Haematologie und Onkologie, Karl-Lennert Tumorzentrum Kiel Schleswig-Holstein
Charité Universitaetsmedizin Berlin KöR, Klinik fuer Haematologie und Onkologie Berlin Germany

More Immatics Biotechnologies GmbH trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05359445 on ClinicalTrials.gov ↗ ← All trials in Germany