Immatics readies IMA402 dose and Phase 1 data for melanoma, ovarian tumors
The PRAME-targeting bispecific's second-half update will set the recommended Phase 2 dose and post monotherapy and checkpoint-combination data in an indication with no approved bispecific of its kind.
Executive Summary
- Immatics is heading toward a dose-finalization and data update for its PRAME-targeting T-cell engaging bispecific, the next test of whether the molecule can produce responses in melanoma and gynecologic cancers where prior lines of therapy have failed.
- The update will report on both monotherapy and checkpoint-inhibitor combination dosing, giving the first read on whether pairing the bispecific with immune-checkpoint blockade adds benefit over the bispecific alone.
- No other industry trial currently pairs the PRAME target with a T-cell engager mechanism in this tumor setting, leaving the asset without a direct mechanism competitor, though a PRAME-directed bispecific from a different developer is advancing in melanoma with a different engagement design.
- The trial's enrollment target, primary endpoints, and completion date have not moved since the study opened, and the sponsor has repeated the same guidance window in successive disclosures, pointing to a program executing on plan rather than one under timing pressure.
The catalyst
Immatics said it expects to determine the final recommended Phase 2 dose (RP2D) and present Phase 1 clinical data for IMA402 with a focus on melanoma and gynecologic cancers, covering both monotherapy and combination with an immune checkpoint inhibitor, in the second half of 2026. The update sits inside NCT05958121, a Phase 1/2 trial of the TCER molecule (T cell-engaging receptor, a bispecific format that links tumor cells to T cells) in recurrent or refractory tumors. Chief Executive Officer Harpreet Singh said the company plans "to report expanded clinical data supporting initiation of indication-specific expansion cohorts" for IMA402. Immatics+1Immatics Announces Full Year 2025 Financial Results and Business UpdateMar 5, 2026IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid TumorsNCT05958121
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The design
The trial enrolls adults with measurable disease by RECIST 1.1, confirmed HLA status, and ECOG performance status of 0 to 1, who have exhausted or are ineligible for standard-of-care treatments. Its Phase 1 primary endpoints track dose-limiting toxicities, treatment-emergent and serious adverse events, and dose interruptions, reductions, or discontinuations; the Phase 2 primary endpoint is overall response rate by RECIST 1.1. Secondary endpoints include progression-free survival, overall survival, duration of response, and disease control rate. The trial targets enrollment of 145 patients across sites in Germany and the Netherlands and has run in Recruiting status since August 2023. NCT05958121IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid TumorsNCT05958121
Operational stability
The registry record shows no change to the primary completion date, no amendment to eligibility criteria, and no change to enrollment count since the trial's only status update, when it moved from Not yet recruiting to Recruiting in August 2023. The sponsor has repeated the identical H2-2026 guidance window in disclosures published five weeks apart, in March and May 2026, with no shift in the stated dates. That combination, a stable protocol and unchanged guidance, points to a trial running on its original operational plan rather than one facing enrollment or timeline pressure. NCT05958121IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid TumorsNCT05958121
The competitive frame
No industry trial in the current landscape combines the PRAME target with a T-cell engager mechanism in melanoma or gynecologic cancers, so IMA402 has no direct mechanism-and-target competitor in this setting. Immunocore's brenetafusp, a PRAME-directed bispecific with a different engagement format, is advancing in a Phase 3 melanoma trial and is the closest mechanism neighbor by target, though it uses a distinct modality. Within Immatics' own pipeline, PRAME is also the target of anzu-cel, a cell therapy running in the Phase 3 SUPRAME trial that the company still expects to support a BLA submission in the first half of 2027, making IMA402's bispecific format a second, non-cellular route to the same tumor antigen. ImmaticsImmatics Announces Full Year 2025 Financial Results and Business UpdateMar 5, 2026
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.