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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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