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A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Trial Profile

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 08 Dec 2025

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At a glance

  • Drugs Pembrolizumab (Primary) ; Rezatapopt (Primary)
  • Indications Advanced breast cancer; Colorectal cancer; Endometrial cancer; Gallbladder cancer; Head and neck cancer; Lung cancer; Ovarian cancer; Prostate cancer; Small cell lung cancer; Solid tumours; Triple negative breast cancer
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Acronyms PYNNACLE
  • Sponsors PMV Pharmaceuticals

Most Recent Events

  • 12 Nov 2025 According to a PMV Pharmaceuticals media release, data emerging from this study and look forward to submitting an NDA in the first quarter of 2027 for platinum-resistant/refractory ovarian cancer.
  • 31 Oct 2025 One more primary end-point is added namely- Phase 2 Monotherapy (Dose Expansion): Response rate assessment to evaluate the clinical activity / efficacy of rezatapopt in ovarian cancer patients.
  • 31 Oct 2025 Planned End Date changed from 14 Jul 2026 to 31 Dec 2027.

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