IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor

Summary

The goal of this clinical trial is to evaluate the safety, tolerability and initial anti-tumor activity of IMA401 as monotherapy or in combination with checkpoint inhibitor in patients with recurrent and/or refractory solid tumors. Patients' HLA status and expression of the MAGE-A4 and/or MAGE-A8 target in the tumor must be confirmed. Primary objective: * To determine the maximum tolerated dose and/or recommended dose for extension for IMA401 as monotherapy and in combination with pembrolizumab Secondary objectives: * To characterize the safety and tolerability of IMA401 as monotherapy and in combination with pembrolizumab * To evaluate initial anti-tumor activity of IMA401 as monotherapy and in combination with pembrolizumab * To describe the pharmacokinetics of IMA401 as monotherapy and in combination with pembrolizumab

Timeline

Start

2022-05-19

Primary completion

2026-03-18

Completion

2029-12

Publications

• Wermke M, Ochsenreither S, Jaeger D, Becker H, Bleckmann A, Bozorgmehr F, Chatterjee M, Groepper S, Haenel M, Hecker JS, Haring MF, Heudobler D, Hilf N, Hofmann M, Hutt M, Mayer-Mokler A, Missel S, Ruh M, Schuster H, Veremchuk O, Kleemiss M, Knop S, Laban S, Sebastian M, Spoerl S, Britten CM, Reinhardt C. MAGE-A4/MAGE-A8-targeted TCR-based bispecific T cell engager in recurrent and/or refractory solid tumors: a phase 1 trial. Nat Med. 2026 May 31. doi: 10.1038/s41591-026-04455-x. Online ahead of print.

Drugs

Indications