IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor
NCT ID: NCT05359445
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
95 participants
INTERVENTIONAL
2022-05-19
2029-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose-Finding IMA401 TCER® Monotherapy (Phase Ia)
Dose-Finding Escalation/De-escalation with IMA401 TCER® (Phase Ia)
IMA401 (Phase Ia)
Intravenous infusions in escalating dose levels
Dose-Finding Combination Therapy with IMA401 TCER® and Pembrolizumab (Phase Ia)
Dose-Finding Escalation/De-escalation of combination therapy with IMA401 TCER and pembrolizumab (Phase Ia)
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
Extension IMA401 TCER® Monotherapy (Phase Ib)
IMA401 monotherapy extension cohort following the determination of the recommended dose for extension (RDE) (Phase Ib)
IMA 401 (Phase Ib)
Treatment at recommended dose for extension (RDE)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Immatics Biotechnologies GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Immatics Biotechnologies GmbH
Role: STUDY_DIRECTOR
Immatics Biotechnologies GmbH
Locations
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Universitaetsklinikum Freiburg, Zentralklinikum, Klinik fuer Innere Medizin I
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitaetsklinikum Heidelberg AöR, Nationales Zentrum fuer Tumorkrankheiten
Heidelberg, Baden-Wurttemberg, Germany
Thoraxklinik Heidelberg gGmbH, Studienzentrum Thoraxonkologie
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen AöR, Comprehensive Cancer Center Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm AöR, ECTU-Early clinical Trials Unit Universitaetsklinikum Ulm Comprehensive Cancer Center Ulm_CCCU
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen AöR, Interdisciplinary Clinical Trial Unit with ECTU
Erlangen, Bavaria, Germany
Klinikum rechts der Isar der TU Muenchen AöR, Klinik und Poliklinik fuer Innere Medizin III
Munich, Bavaria, Germany
Klinikum Nuernberg, Klinik fuer Innere Medizin 5, Abteilung Onkologie/Haematologie
Nuremberg, Bavaria, Germany
Universitaetsklinikum Regensburg AöR, Klinik fuer Innere Medizin 3
Regensburg, Bavaria, Germany
Universitaetsklinikum Wuerzburg AöR, Interdisziplinaeres Studienzentrum mit ECTU
Würzburg, Bavaria, Germany
Goethe Universitaetsklinikum Frankfurt AöR, Medizinische Klinik II
Frankfurt am Main, Hesse, Germany
Sana Klinikum Offenbach GmbH, Klinik für Pneumologie/ Thoraxzentrum Rhein-Main
Offenbach, Hesse, Germany
Universitätsmedizin Göttingen, Klinik für Hämatologie und Onkologie
Göttingen, Lower Saxony, Germany
Medizinische Hochschule Hannover, Klinik fuer Haematologie, Haemostaseologie, Onkologie und Stammzelltransplantation
Hanover, Lower Saxony, Germany
Universitätsklinikum Bonn AöR, Medizinische Klinik IIII
Bonn, North Rhine-Westphalia, Germany
Marien Hospital Duesseldorf GmbH, Klinik fuer Onkologie/Haematologie und Palliativmedizin
Düsseldorf, North Rhine-Westphalia, Germany
Universitaetsklinikum Muenster AöR, Medizinische Klinik A
Münster, North Rhine-Westphalia, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, III. Medizinische Klinik
Mainz, Rhineland-Palatinate, Germany
Klinikum Chemnitz gGmbH, Klinik für Innere Medizin III
Chemnitz, Saxony, Germany
Universitaetsklinikum C. - G. - Carus Dresden, Technische Universitaet Dresden AöR, NCT/UCC Early Clinical Trial Unit
Dresden, Saxony, Germany
Universitaet Leipzig, Universitaeres Krebszentrum Leipzig (UCCL)
Leipzig, Saxony, Germany
Universitaetsklinikum Schleswig- Holstein, Campus Kiel, Medizinische Klinik II Haematologie und Onkologie, Karl-Lennert Tumorzentrum
Kiel, Schleswig-Holstein, Germany
Charité Universitaetsmedizin Berlin KöR, Klinik fuer Haematologie und Onkologie
Berlin, , Germany
Countries
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Central Contacts
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Related Links
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Corporate Website
Other Identifiers
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2023-506854-19-00
Identifier Type: OTHER
Identifier Source: secondary_id
IMA401-101
Identifier Type: -
Identifier Source: org_study_id
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