IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
June 29, 2026 updated by: Immatics Biotechnologies GmbH
A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) Targeting PRAME, as Monotherapy or in Combination With a Checkpoint Inhibitor in Patients With Recurrent and/or Refractory Solid Tumors
The goal of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA402 in patients with recurrent and/or refractory solid tumors.
Primary objectives:
- To determine the maximum tolerated doses and/or recommended doses for extensions for IMA402 as monotherapy and in combination with pembrolizumab (Phase Ia)
- To characterize the safety and tolerability of IMA402 as monotherapy and in combination (Phase I/II)
- To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II)
Secondary objectives:
- To evaluate the initial anti-tumor activity of IMA402 as monotherapy and in combination (Phase I)
- To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II)
- To describe the PK of IMA402 as monotherapy and in combination (Phase I/II)
Study Overview
Status
Recruiting
Detailed Description
The study will be conducted in two phases:
- Phase Ia: Dose escalation/de-escalation
- Phase Ib: Dose extension
- Phase II: Dose extension in selected Indication-specific extension cohort(s) (ISEC)
Study Type
Interventional
Enrollment (Estimated)
400
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Immatics Biotechnologies GmbH
- Phone Number: Please E-Mail
- Email: Ctgovinquiries@immatics.com
Study Locations
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Baden-Wurttemberg
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Heidelberg, Baden-Wurttemberg, Germany, 69120
- Recruiting
- Universitaetsklinikum Heidelberg AöR
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Heidelberg, Baden-Wurttemberg, Germany, 69126
- Not yet recruiting
- Thoraxklinik Heidelberg gGmbH
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Mannheim, Baden-Wurttemberg, Germany, 68167
- Recruiting
- Universitaetsklinikum Mannheim GmbH
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Tübingen, Baden-Wurttemberg, Germany, 72076
- Not yet recruiting
- Universitaetsklinikum Tuebingen AöR
-
Ulm, Baden-Wurttemberg, Germany, 89081
- Recruiting
- Universitaetsklinikum Ulm AöR
-
-
Bavaria
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Erlangen, Bavaria, Germany, 91054
- Recruiting
- Universitaetsklinikum Erlangen AöR
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Nuremberg, Bavaria, Germany, 90419
- Recruiting
- Klinikum Nürnberg
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Regensburg, Bavaria, Germany, 93053
- Recruiting
- Universitaetsklinikum Regensburg
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Würzburg, Bavaria, Germany, 97080
- Recruiting
- Universitaetsklinikum Wuerzburg AöR
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Hesse
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Frankfurt am Main, Hesse, Germany, 60590
- Recruiting
- Goethe University Frankfurt
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Giessen, Hesse, Germany, 35392
- Recruiting
- Justus-Liebig-Universitaet Giessen
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Marburg, Hesse, Germany, 35043
- Recruiting
- Philipps-Universitaet Marburg
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Offenbach, Hesse, Germany, 63069
- Not yet recruiting
- Sana Klinikum Offenbach GmbH
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Lower Saxony
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Buxtehude, Lower Saxony, Germany, 21614
- Recruiting
- Elbe Kliniken Stade- Buxtehude Elbe Klinikum Buxtehude gGmbH
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Göttingen, Lower Saxony, Germany, 37075
- Not yet recruiting
- Universitaetsmedizin Goettingen
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Germany, 53127
- Recruiting
- Universitaetsklinikum Bonn AöR
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Düsseldorf, North Rhine-Westphalia, Germany, 40479
- Recruiting
- Marien Hospital Duesseldorf GmbH
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Essen, North Rhine-Westphalia, Germany, 45147
- Recruiting
- Universitaetsklinikum Essen AöR
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Essen, North Rhine-Westphalia, Germany, 45136
- Recruiting
- KEM I Evang. Kliniken Essen-Mitte gGmbH
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Minden, North Rhine-Westphalia, Germany, 32429
- Recruiting
- Johannes Wesling Klinikum Minden
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Münster, North Rhine-Westphalia, Germany, 48149
- Not yet recruiting
- Universitaet Muenster
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Saxony
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Chemnitz, Saxony, Germany, 09116
- Recruiting
- Klinikum Chemnitz gGmbH
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Dresden, Saxony, Germany, 01307
- Recruiting
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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Leipzig, Saxony, Germany, 04103
- Recruiting
- University of Leipzig
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Saxony-Anhalt
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Magdeburg, Saxony-Anhalt, Germany, 39120
- Recruiting
- Universitaetsklinikum Magdeburg AöR
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Groningen, Netherlands, 9713 GZ
- Recruiting
- Universitair Medisch Centrum Groningen
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Utrecht, Netherlands, 3584 CX
- Recruiting
- Universitair Medisch Centrum Utrecht
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North Holland
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Amsterdam, North Holland, Netherlands, 1066 CX
- Recruiting
- Antoni von Leeuwenhoek- Netherlands Cancer Institute
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South Holland
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Leiden, South Holland, Netherlands, 2333 ZA
- Recruiting
- Leiden Universitair Medisch Centrum
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients ≥ 18 years old
- 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 indicated standard-of-care treatments per cohort
- 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:
- Other active malignancies that require treatment or that might interfere with the trial endpoints
- The patient is pregnant or is breastfeeding
- History of hypersensitivity to components of IMA402 or rescue medications; hypersensitivity to or contraindication according to current SmPC for respective combination medicinal product
- The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator's or sponsor'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, history of bleeding into brain metastases, known brain metastases who are receiving therapeutic anticoagulation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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)
|
IV infusions
IMA402 IV infusions and checkpoint inhibitor
|
|
Experimental: Dose escalation/de-escalation (Phase Ia)
Dose-Finding of IMA402 as monotherapy or in combination with checkpoint inhibitor (Phase Ia)
|
IV infusions
IMA402 IV infusions and checkpoint inhibitor
|
|
Experimental: Dose extension (Phase Ib)
Extension cohorts of IMA402 as monotherapy or in combination based on maximum tolerated dose (MTD) and/or recommended doses for extensions (RDEs) (Phase Ib)
|
IV infusions
IMA402 IV infusions and checkpoint inhibitor
IMA402 IV infusions and chemotherapy
IMA402 and IMA401 IV infusions
IMA402 IV infusions and monoclonal antibody
IMA402 IV infusions and chemotherapy +/- monoclonal antibody
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Phase I: Number of patients with dose limiting toxicities (DLTs)
Time Frame: 24 months
|
24 months
|
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Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs)
Time Frame: 40 months
|
40 months
|
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Phase I/II: Number of patients with serious TEAEs
Time Frame: 40 months
|
40 months
|
|
Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations
Time Frame: 40 months
|
40 months
|
|
Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations
Time Frame: 40 months
|
40 months
|
|
Phase II: Overall response rate (ORR) based on best overall response (BOR) of complete response (CR) and partial response (PR) locally assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
Time Frame: 40 months
|
40 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST
Time Frame: 37 months
|
37 months
|
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Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST
Time Frame: 40 months
|
40 months
|
|
Phase I/II: Disease control rate (DCR) of CR, PR or stable disease (SD) (lasting 6 or more weeks) following the initiation of IMA402 based on RECIST v1.1 and iRECIST
Time Frame: 40 months
|
40 months
|
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Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST
Time Frame: 40 months
|
40 months
|
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Phase I/II: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST
Time Frame: 40 months
|
40 months
|
|
Phase I/II: Overall survival (OS)
Time Frame: 40 months
|
40 months
|
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Phase I/II: Determination of PK parameter: half-life (t1/2)
Time Frame: 40 months
|
40 months
|
|
Phase I/II: Determination of PK parameter: minimal serum concentration (Cmin)
Time Frame: 40 months
|
40 months
|
|
Phase I/II: Determination of PK parameter: maximal serum concentration (Cmax)
Time Frame: 40 months
|
40 months
|
|
Phase I/II: Determination of PK parameter: area under the curve (AUC)
Time Frame: 40 months
|
40 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Immatics Biotechnologies GmbH, Immatics Biotechnologies GmbH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 9, 2023
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
July 14, 2023
First Submitted That Met QC Criteria
July 14, 2023
First Posted (Actual)
July 24, 2023
Study Record Updates
Last Update Posted (Actual)
July 1, 2026
Last Update Submitted That Met QC Criteria
June 29, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMA402-101
- 2022-503133-54-00 (Other Identifier: Clinical Trials Information System)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is not a plan to make IPD available.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.