IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
NCT ID: NCT05958121
Last Updated: 2025-11-18
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/PHASE2
145 participants
INTERVENTIONAL
2023-08-09
2027-09-30
Brief Summary
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Primary objectives:
* To determine the maximum tolerated dose and/or recommended dose for extension for IMA402 (Phase I)
* To characterize the safety and tolerability of IMA402 (Phase I/II)
* To evaluate anti-tumor activity of IMA402 (Phase II)
Secondary objectives:
* To evaluate the initial anti-tumor activity of IMA402 (Phase I)
* To evaluate anti-tumor activity of IMA402 (Phase II)
* To describe the PK of IMA402 (Phase I/II)
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Detailed Description
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* Phase Ia: Dose escalation/de-escalation
* Phase Ib: Dose extension
* Phase II: Dose extension in selected Indication-specific extension cohort(s) (ISEC)
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose escalation/de-escalation (Phase Ia)
Dose-Finding of IMA402 (Phase Ia)
IMA402 (Phase Ia)
Intravenous infusions in escalating dose levels
Dose extension (Phase Ib)
IMA402 monotherapy extension cohorts based on maximum tolerated dose (MTD) and/or recommended doses for extensions (RDEs) (Phase Ib)
IMA402 (Phase Ib)
Treatment at MTD and/or RDE (Phase Ib)
Dose extension (Phase II)
Selected ISEC investigated on MTD/RDEs based on a manageable/favorable safety profile and initial signs of anti-tumor activity (Phase II)
IMA402 (Phase II)
Treatment at MTD/RDE based on a manageable/favorable safety profile and initial signs of anti-tumor activity of selected ISEC (Phase II)
Interventions
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IMA402 (Phase Ia)
Intravenous infusions in escalating dose levels
IMA402 (Phase Ib)
Treatment at MTD and/or RDE (Phase Ib)
IMA402 (Phase II)
Treatment at MTD/RDE based on a manageable/favorable safety profile and initial signs of anti-tumor activity of selected ISEC (Phase II)
Eligibility Criteria
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Inclusion Criteria
* Patients must have a specific pathologically confirmed and documented advanced and/or metastatic solid tumor indication
* Patients must have received or not be eligible for all available indicated standard-of-care treatments
* Measurable disease according to RECIST 1.1
* Confirmed HLA status
* ECOG Performance Status of 0 to 1
* Adequate baseline hematologic, hepatic and renal function, acceptable coagulation status
Exclusion Criteria
* The patient is pregnant or is breastfeeding
* History of hypersensitivity to components of IMA402 or rescue medications, if no alternative treatment option is available
* The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures
* Patients with active brain 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 Heidelberg AöR
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm AöR
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen AöR
Erlangen, Bavaria, Germany
Klinikum Nürnberg
Nuremberg, Bavaria, Germany
Universitaetsklinikum Regensburg
Regensburg, Bavaria, Germany
Universitaetsklinikum Wuerzburg AöR
Würzburg, Bavaria, Germany
Justus-Liebig-Universitaet Giessen
Giessen, Hesse, Germany
Philipps-Universitaet Marburg
Marburg, Hesse, Germany
Elbe Kliniken Stade- Buxtehude Elbe Klinikum Buxtehude gGmbH
Buxtehude, Lower Saxony, Germany
Universitaetsklinikum Bonn AöR
Bonn, North Rhine-Westphalia, Germany
Marien Hospital Duesseldorf GmbH
Düsseldorf, North Rhine-Westphalia, Germany
KEM I Evang. Kliniken Essen-Mitte gGmbH
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen AöR
Essen, North Rhine-Westphalia, Germany
Johannes Wesling Klinikum Minden
Minden, North Rhine-Westphalia, Germany
Universitaet Muenster
Münster, North Rhine-Westphalia, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Dresden, Saxony, Germany
University Of Leipzig
Leipzig, Saxony, Germany
Universitaetsklinikum Magdeburg AöR
Magdeburg, Saxony-Anhalt, Germany
Antoni von Leeuwenhoek- Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands
Leiden Universitair Medisch Centrum
Leiden, South Holland, Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
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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2022-503133-54-00
Identifier Type: OTHER
Identifier Source: secondary_id
IMA402-101
Identifier Type: -
Identifier Source: org_study_id
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