Status:

RECRUITING

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

Lead Sponsor:

Immatics Biotechnologies GmbH

Conditions:

Refractory Cancer

Recurrent Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

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 determin...

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)

Eligibility Criteria

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

Key Trial Info

Start Date :

August 9 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2027

Estimated Enrollment :

145 Patients enrolled

Trial Details

Trial ID

NCT05958121

Start Date

August 9 2023

End Date

September 1 2027

Last Update

November 18 2025

Active Locations (24)

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Page 1 of 6 (24 locations)

1

Universitaetsklinikum Heidelberg AöR

Heidelberg, Baden-Wurttemberg, Germany, 69120

2

Universitaetsklinikum Mannheim GmbH

Mannheim, Baden-Wurttemberg, Germany, 68167

3

Universitaetsklinikum Ulm AöR

Ulm, Baden-Wurttemberg, Germany, 89081

4

Universitaetsklinikum Erlangen AöR

Erlangen, Bavaria, Germany, 91054