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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

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Trial Profile

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 of Trial: Phase I/II

Latest Information Update: 20 Nov 2025

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At a glance

  • Drugs IMA 402 (Primary)
  • Indications Gynaecological cancer; Lung cancer; Malignant melanoma; Ovarian cancer; Skin cancer; Solid tumours; Synovial sarcoma; Uterine cancer; Uveal melanoma
  • Focus Adverse reactions; First in man; Proof of concept; Therapeutic Use
  • Sponsors Immatics N.V.

Most Recent Events

  • 12 Nov 2025 According to an Immatics N.V. media release, company is exploring the initiation of additional phase 1b cohorts in 2026, including phase 1b dose expansion at two distinct dose levels to determine the final recommended Phase 2 dose (RP2D), evaluating IMA402 both as monotherapy and in combination with an immune checkpoint inhibitor, with a focus on melanoma and gynecologic cancers.
  • 12 Nov 2025 According to an Immatics N.V. media release, the company reported updated phase 1a dose-escalation data as of the September 26, 2025 data cutoff, including results from 80 heavily pre-treated patients treated with its TCER pipeline candidates, IMA402 PRAME Bispecific and IMA401 MAGEA4/8 Bispecific, outlined next steps for clinical development, and announced the initiation of Phase 1b dose expansion for IMA402.
  • 12 Nov 2025 Results presented in an Immatics N.V. media release

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