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

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

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

Conditions4

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