Study of IMA402, a T Cell-Engaging Receptor Drug, Alone or With Checkpoint Inhibitor to Treat Adults with Recurrent or Resistant Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, and anti-tumor activity of IMA402 in adults with recurrent andor refractory solid tumors. This Phase III trial aims to determine the maximum tolerated doses and recommended doses for IMA402 alone and in combination with pembrolizumab. The study also seeks to characterize safety and anti-tumor effects, along with pharmacokinetics, in patients who have advanced or metastatic solid tumors that are measurable and confirmed by specific tests. The trial has three phases Phase Ia focuses on dose escalation and de-escalation to find safe dosage levels Phase Ib involves dose extension cohorts to further evaluate these doses and Phase II studies selected patient groups to examine safety and anti-tumor activity more closely. Treatments include IMA402 given by intravenous infusions either alone or combined with checkpoint inhibitors, chemotherapy, monoclonal antibodies, or IMA401. Participants receive these infusions according to their assigned group and dose level. Participants will undergo assessments to monitor treatment safety and effectiveness, including evaluations of adverse events, tumor response using standard criteria, and pharmacokinetic measurements over up to 40 months. Researchers will track dose limiting toxicities, treatment-emergent adverse events, and tumor response rates. Safety and tolerability are closely monitored throughout, with visits scheduled regularly to assess health status and treatment effects during the trial period.

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