Cancer Clinical Trial
Official title:
A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific TCER® Targeting PRAME, in Patients With Recurrent and/or Refractory Solid Tumors
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)
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) ;
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