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

NCT05958121 | Recruiting Phase 1 DMC

• 2 other identifiers: IMA402-1012022-503133-54-00
• Study Type: interventional
• Target: 145
• Locations: 2 countries
• Sites: 24

Brief Summary

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)

Conditions

Refractory Cancer; Recurrent Cancer; Solid Tumor, Adult; Cancer

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (10)

• 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

Study Arms (3)

Dose escalation/de-escalation (Phase Ia)

EXPERIMENTAL

Dose-Finding of IMA402 (Phase Ia)

Biological: IMA402 (Phase Ia)

Dose extension (Phase Ib)

EXPERIMENTAL

IMA402 monotherapy extension cohorts based on maximum tolerated dose (MTD) and/or recommended doses for extensions (RDEs) (Phase Ib)

Biological: IMA402 (Phase Ib)

Dose extension (Phase II)

EXPERIMENTAL

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)

Interventions

IMA402 (Phase Ia) BIOLOGICAL

Intravenous infusions in escalating dose levels

Dose escalation/de-escalation (Phase Ia)

IMA402 (Phase Ib) BIOLOGICAL

Treatment at MTD and/or RDE (Phase Ib)

Dose extension (Phase Ib)

IMA402 (Phase II) BIOLOGICAL

Treatment at MTD/RDE based on a manageable/favorable safety profile and initial signs of anti-tumor activity of selected ISEC (Phase II)

Dose extension (Phase II)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Immatics Biotechnologies GmbH: lead

Study Sites (24)

Universitaetsklinikum Heidelberg AöR

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Universitaetsklinikum Mannheim GmbH

Mannheim, Baden-Wurttemberg, 68167, Germany

RECRUITING

Universitaetsklinikum Ulm AöR

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

Universitaetsklinikum Erlangen AöR

Erlangen, Bavaria, 91054, Germany

RECRUITING

Klinikum Nürnberg

Nuremberg, Bavaria, 90419, Germany

RECRUITING

Universitaetsklinikum Regensburg

Regensburg, Bavaria, 93053, Germany

RECRUITING

Universitaetsklinikum Wuerzburg AöR

Würzburg, Bavaria, 97080, Germany

RECRUITING

Justus-Liebig-Universitaet Giessen

Giessen, Hesse, 35392, Germany

RECRUITING

Philipps-Universitaet Marburg

Marburg, Hesse, 35043, Germany

RECRUITING

Elbe Kliniken Stade- Buxtehude Elbe Klinikum Buxtehude gGmbH

Buxtehude, Lower Saxony, 21614, Germany

RECRUITING

Universitaetsklinikum Bonn AöR

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Marien Hospital Duesseldorf GmbH

Düsseldorf, North Rhine-Westphalia, 40479, Germany

RECRUITING

KEM I Evang. Kliniken Essen-Mitte gGmbH

Essen, North Rhine-Westphalia, 45136, Germany

RECRUITING

Universitaetsklinikum Essen AöR

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

Johannes Wesling Klinikum Minden

Minden, North Rhine-Westphalia, 32429, Germany

RECRUITING

Universitaet Muenster

Münster, North Rhine-Westphalia, 48149, Germany

NOT YET RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, Saxony, 09116, Germany

RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR

Dresden, Saxony, 01307, Germany

RECRUITING

University Of Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

Universitaetsklinikum Magdeburg AöR

Magdeburg, Saxony-Anhalt, 39120, Germany

RECRUITING

Antoni von Leeuwenhoek- Netherlands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

RECRUITING

Leiden Universitair Medisch Centrum

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

RECRUITING

Related Links

• Corporate Website

MeSH Terms

Conditions

Neoplasms; Recurrence

Interventions

Clinical Trials, Phase II as Topic

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Immatics Biotechnologies GmbH

  Immatics Biotechnologies GmbH

  STUDY DIRECTOR

Central Study Contacts

Immatics Biotechnologies GmbH

CONTACT

Please E-Mail; Ctgovinquiries@immatics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: August 9, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (4); DE (20)