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

Last updated: April 2, 2025
Sponsor: Immatics Biotechnologies GmbH
Overall Status: Active - Recruiting

Phase

1/2

Condition

Cancer

Treatment

IMA402 (Phase II)

IMA402 (Phase Ib)

IMA402 (Phase Ia)

Clinical Study ID

NCT05958121
IMA402-101
2022-503133-54-00
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥ 18 years old

  • Patients must have a specific pathologically confirmed and documented advancedand/or metastatic solid tumor indication

  • Patients must have received or not be eligible for all available indicatedstandard-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 coagulationstatus

Exclusion

Exclusion Criteria:

  • Other active malignancies that require treatment or that might interfere with thetrial 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 noalternative treatment option is available

  • The patient has concurrent severe and/or uncontrolled medical disease. Any otherhealth condition that would, in the investigator's judgement, contraindicate thepatient's participation in the clinical trial because of safety concerns orcompliance with clinical trial procedures

  • Patients with active brain metastases

Study Design

Total Participants: 145
Treatment Group(s): 3
Primary Treatment: IMA402 (Phase II)
Phase: 1/2
Study Start date:
August 09, 2023
Estimated Completion Date:
September 30, 2027

Study 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)

Connect with a study center

  • Universitaetsklinikum Heidelberg AöR

    Heidelberg, Baden-Wuerttemberg 69120
    Germany

    Active - Recruiting

  • Universitaetsklinikum Mannheim GmbH

    Mannheim, Baden-Wuerttemberg 68167
    Germany

    Active - Recruiting

  • Universitaetsklinikum Ulm AöR

    Ulm, Baden-Wuerttemberg 89081
    Germany

    Active - Recruiting

  • Universitaetsklinikum Erlangen AöR

    Erlangen, Bavaria 91054
    Germany

    Active - Recruiting

  • Universitatsklinikum Erlangen AöR

    Erlangen, Bavaria 91054
    Germany

    Active - Recruiting

  • Klinikum Nürnberg

    Nuremberg, Bavaria 90419
    Germany

    Active - Recruiting

  • Universitaetsklinikum Regensburg

    Regensburg, Bavaria 93053
    Germany

    Active - Recruiting

  • Universitaetsklinikum Wuerzburg AöR

    Wuerzburg, Bavaria 97080
    Germany

    Active - Recruiting

  • Universitatsklinikum Wuerzburg AöR

    Wuerzburg, Bavaria 97080
    Germany

    Active - Recruiting

  • Universitaetsklinikum Bonn AöR

    Bonn, North Rhine-Westphalia 53127
    Germany

    Active - Recruiting

  • Marien Hospital Duesseldorf GmbH

    Duesseldorf, North Rhine-Westphalia 40479
    Germany

    Active - Recruiting

  • KEM I Evang. Kliniken Essen-Mitte gGmbH

    Essen, North Rhine-Westphalia 45136
    Germany

    Active - Recruiting

  • Universitaetsklinikum Essen AöR

    Essen, North Rhine-Westphalia 45147
    Germany

    Active - Recruiting

  • Johannes Wesling Klinikum Minden

    Minden, North Rhine-Westphalia 32429
    Germany

    Active - Recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz, Saxony 09116
    Germany

    Active - Recruiting

  • Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR

    Dresden, Saxony 01307
    Germany

    Active - Recruiting

  • University Of Leipzig

    Leipzig, Saxony 04103
    Germany

    Active - Recruiting

  • Universitaetsklinikum Magdeburg AöR

    Magdeburg, Saxony-Anhalt 39120
    Germany

    Active - Recruiting

  • Antoni von Leeuwenhoek- Netherlands Cancer Institute

    Amsterdam, North Holland 1066 CX
    Netherlands

    Active - Recruiting

  • Leiden Universitair Medisch Centrum

    Leiden, South Holland 2333 ZA
    Netherlands

    Active - Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX
    Netherlands

    Active - Recruiting

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