IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors

August 31, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Recruiting
        • Universitaetsklinikum Heidelberg AöR
      • Heidelberg, Baden-Wurttemberg, Germany, 69126
        • Recruiting
        • Thoraxklinik Heidelberg gGmbH
      • Mannheim, Baden-Wurttemberg, Germany, 68167
        • Recruiting
        • Universitaetsklinikum Mannheim GmbH
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Recruiting
        • Universitaetsklinikum Tuebingen AöR
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Recruiting
        • Universitaetsklinikum Ulm AöR
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Universitaetsklinikum Erlangen AöR
      • Nuremberg, Bavaria, Germany, 90419
        • Completed
        • Klinikum Nürnberg
      • Regensburg, Bavaria, Germany, 93053
        • Recruiting
        • Universitaetsklinikum Regensburg
      • Würzburg, Bavaria, Germany, 97080
        • Recruiting
        • Universitaetsklinikum Wuerzburg AöR
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Recruiting
        • Goethe University Frankfurt
      • Giessen, Hesse, Germany, 35392
        • Recruiting
        • Justus-Liebig-Universitaet Giessen
      • Marburg, Hesse, Germany, 35043
        • Recruiting
        • Philipps-Universitaet Marburg
      • Offenbach, Hesse, Germany, 63069
        • Not yet recruiting
        • Sana Klinikum Offenbach GmbH
    • Lower Saxony
      • Buxtehude, Lower Saxony, Germany, 21614
        • Recruiting
        • Elbe Kliniken Stade- Buxtehude Elbe Klinikum Buxtehude gGmbH
      • Göttingen, Lower Saxony, Germany, 37075
        • Not yet recruiting
        • Universitaetsmedizin Goettingen
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Recruiting
        • Universitaetsklinikum Bonn AöR
      • Düsseldorf, North Rhine-Westphalia, Germany, 40479
        • Recruiting
        • Marien Hospital Duesseldorf GmbH
      • Essen, North Rhine-Westphalia, Germany, 45147
        • Recruiting
        • Universitaetsklinikum Essen AöR
      • Essen, North Rhine-Westphalia, Germany, 45136
        • Recruiting
        • KEM I Evang. Kliniken Essen-Mitte gGmbH
      • Minden, North Rhine-Westphalia, Germany, 32429
        • Recruiting
        • Johannes Wesling Klinikum Minden
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Not yet recruiting
        • Universitaet Muenster
    • Saxony
      • Chemnitz, Saxony, Germany, 09116
        • Completed
        • Klinikum Chemnitz gGmbH
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • University of Leipzig
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39120
        • Recruiting
        • Universitaetsklinikum Magdeburg AöR
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • Universitair Medisch Centrum Groningen
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • Universitair Medisch Centrum Utrecht
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1066 CX
        • Recruiting
        • Antoni von Leeuwenhoek- Netherlands Cancer Institute
    • South Holland
      • Leiden, South Holland, Netherlands, 2333 ZA
        • Recruiting
        • Leiden Universitair Medisch Centrum

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
Drug: IMA402
IV infusions
Drug: IMA402 and checkpoint inhibitor
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)
Drug: IMA402
IV infusions
Drug: IMA402 and checkpoint inhibitor
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)
Drug: IMA402
IV infusions
Drug: IMA402 and checkpoint inhibitor
IMA402 IV infusions and checkpoint inhibitor
Drug: IMA402 and chemotherapy
IMA402 IV infusions and chemotherapy
Drug: IMA402 and IMA401
IMA402 and IMA401 IV infusions
Drug: IMA402 and monoclonal antibody
IMA402 IV infusions and monoclonal antibody
Drug: IMA402 and chemotherapy +/- monoclonal antibody
IMA402 IV infusions and chemotherapy +/- monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Phase I: Number of patients with dose limiting toxicities (DLTs)
Time Frame: 24 months
24 months
Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs)
Time Frame: 40 months
40 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST
Time Frame: 40 months
40 months
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Immatics Biotechnologies GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 9, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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