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

A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific TCER® Targeting PRAME, 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 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)

Study Overview

• Status: Recruiting
• Conditions: Cancer; Solid Tumor, Adult; Refractory Cancer; Recurrent Cancer
• Intervention / Treatment: Biological: IMA402 (Phase Ia); Biological: IMA402 (Phase Ib); Biological: IMA402 (Phase II)

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): 145
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Immatics Biotechnologies GmbH; Phone Number: Please E-Mail; Email: Ctgovinquiries@immatics.com

Study Locations

• Germany
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • Recruiting
      • Universitaetsklinikum Heidelberg AöR
    • Mannheim, Baden-Wurttemberg, Germany, 68167
      • Recruiting
      • Universitaetsklinikum Mannheim GmbH
    • Ulm, Baden-Wurttemberg, Germany, 89081
      • Recruiting
      • Universitaetsklinikum Ulm AöR
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Universitaetsklinikum Erlangen AöR
    • Nuremberg, Bavaria, Germany, 90419
      • Recruiting
      • Klinikum Nürnberg
    • Regensburg, Bavaria, Germany, 93053
      • Recruiting
      • Universitaetsklinikum Regensburg
    • Würzburg, Bavaria, Germany, 97080
      • Recruiting
      • Universitaetsklinikum Wuerzburg AöR
  • Hesse
    • Giessen, Hesse, Germany, 35392
      • Recruiting
      • Justus-Liebig-Universitaet Giessen
    • Marburg, Hesse, Germany, 35043
      • Recruiting
      • Philipps-Universitaet Marburg
  • Lower Saxony
    • Buxtehude, Lower Saxony, Germany, 21614
      • Recruiting
      • Elbe Kliniken Stade- Buxtehude Elbe Klinikum Buxtehude gGmbH
  • 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
      • Recruiting
      • 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

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 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:

• Other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation/de-escalation (Phase Ia); Dose-Finding of IMA402 (Phase Ia)	Biological: IMA402 (Phase Ia); Intravenous infusions in escalating dose levels
Experimental: Dose extension (Phase Ib); IMA402 monotherapy extension cohorts based on maximum tolerated dose (MTD) and/or recommended doses for extensions (RDEs) (Phase Ib)	Biological: IMA402 (Phase Ib); Treatment at MTD and/or RDE (Phase Ib)
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)	Biological: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Phase I: Number of patients with dose limiting toxicities (DLTs)	24 months
Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs)	40 months
Phase I/II: Number of patients with serious TEAEs	40 months
Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations	40 months
Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations	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)	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	37 months
Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST	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	40 months
Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST	40 months
Phase I/II: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST	40 months
Phase I/II: Overall survival (OS)	40 months
Phase I/II: Determination of PK parameter: half-life (t1/2)	40 months
Phase I/II: Determination of PK parameter: minimal serum concentration (Cmin)	40 months
Phase I/II: Determination of PK parameter: maximal serum concentration (Cmax)	40 months
Phase I/II: Determination of PK parameter: area under the curve (AUC)	40 months

Collaborators and Investigators

• Sponsor: Immatics Biotechnologies GmbH
• Investigators: Study Director: Immatics Biotechnologies GmbH, Immatics Biotechnologies GmbH

Publications and helpful links

Helpful Links

• Corporate Website

Study record dates

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): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Neoplasms; Recurrence; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Study Characteristics; Clinical Trials as Topic; Clinical Studies as Topic; Clinical Trials, Phase II as Topic
• 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