A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) targeting PRAME, in Patients with Recurrent and/or Refractory Solid Tumors
- Conditions
- Solid TumorsMedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-503133-54-00
- Lead Sponsor
- Immatics Biotechnologies GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 155
Patients = 18 years old, Pathologically confirmed and documented advanced and/or metastatic solid tumors with defined PRAME tumor target expression, Confirmed HLA status, Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1, Patients must have received or not be eligible for all available indicated standard-of-care treatments, Adequate baseline hematologic, renal and hepatic function, acceptable coagulation status
Other active malignancies that require treatment or that might interfere with the trial endpoints, Patient is pregnant or is breastfeeding, History of hypersensitivity to components of IMA402 or rescue medications, 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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method