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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllImmatics Biotechnologies GmbH
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In plain words

What the trial is, and whether it could suit you

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 doses and/or recommended doses for extensions for IMA402 as monotherapy and in combination with pembrolizumab (Phase Ia) * To characterize the safety and tolerability of IMA402 as monotherapy and in combination (Phase I/II) * To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II) Secondary objectives: * To evaluate the initial anti-tumor activity of IMA402 as monotherapy and in combination (Phase I) * To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II) * To describe the PK of IMA402 as monotherapy and in combination (Phase I/II)

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 indicated standard-of-care treatments per cohort * 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 * The patient is pregnant or is breastfeeding * History of hypersensitivity to components of IMA402 or rescue medications; hypersensitivity to or contraindication according to current SmPC for respective combination medicinal product * The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator's or sponsor'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, history of bleeding into brain metastases, known brain metastases who are receiving therapeutic anticoagulation
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What it tests

  • IMA402
  • IMA402 and checkpoint inhibitor
  • IMA402 and chemotherapy
  • IMA402 and IMA401
  • IMA402 and monoclonal antibody
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Where

29 sites
Universitaetsklinikum Heidelberg AöR
Heidelberg, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, Germany
Universitaetsklinikum Mannheim GmbH
Mannheim, Germany
Universitaetsklinikum Tuebingen AöR
Tübingen, Germany
Universitaetsklinikum Ulm AöR
Ulm, Germany
Universitaetsklinikum Erlangen AöR
Erlangen, Germany
Klinikum Nürnberg
Nuremberg, Germany
Universitaetsklinikum Regensburg
Regensburg, Germany

…and 21 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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