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)
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
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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