NCT05958121

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 145 (estimated)
• Sponsor: Immatics Biotechnologies GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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)

Conditions

• Refractory Cancer
• Recurrent Cancer
• Solid Tumor, Adult
• Cancer

Interventions

Type	Name	Description
BIOLOGICAL	IMA402 (Phase Ia)	Intravenous infusions in escalating dose levels
BIOLOGICAL	IMA402 (Phase Ib)	Treatment at MTD and/or RDE (Phase Ib)
BIOLOGICAL	IMA402 (Phase II)	Treatment at MTD/RDE based on a manageable/favorable safety profile and initial signs of anti-tumor activity of selected ISEC (Phase II)

Timeline

• Start date: 2023-08-09
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2023-07-24
• Last updated: 2025-11-18

Locations

24 sites across 2 countries: Germany, Netherlands