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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)

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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: 26 Sep 2025

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At a glance

  • Drugs Pembrolizumab (Primary) ; Rezatapopt (Primary)
  • Indications Advanced breast cancer; Endometrial 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

  • 07 Aug 2025 According to a PMV Pharmaceuticals media release, company will host an investor webinar on Wednesday, September 10, 2025 at 8:00 AM ET to review interim analysis data from this Phase 2 PYNNACLE clinical trial. This interim analysis will include data for approximately 65 patients who have had at least 18 weeks of follow-up, of which approximately 45% are in the ovarian cancer cohort.
  • 09 May 2025 According to a PMV Pharmaceuticals Media Release, PMV Pharma plans to provide interim analysis which will include data for approximately 50 patients, of which approximately 40% are in the ovarian cancer cohort, who have been followed for at least 18 weeks.
  • 03 Mar 2025 According to a PMV Pharmaceuticals Media Release, PYNNACLE Phase 1 data of rezatapopt in advanced breast cancer patients featured in a poster presentation at the 2024 San Antonio Breast Cancer Symposium.

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