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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: 10 Jun 2024

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At a glance

  • Drugs Pembrolizumab (Primary) ; Rezatapopt (Primary)
  • Indications Endometrial cancer; Ovarian cancer; Prostate cancer; Small cell lung cancer; Solid tumours
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Acronyms PYNNACLE
  • Sponsors PMV Pharmaceuticals
  • Most Recent Events

    • 27 Mar 2024 According to a PMV Pharmaceuticals Media Release, the first patient has been dosed in the registrational Phase 2 portion of the PYNNACLE trial. The trial is designed to enroll 114 patients across five cohorts at approximately 60 sites across the U.S., Europe, and Asia-Pacific.
    • 18 Mar 2024 According to a PMV Pharmaceuticals Media Release, this trial includes an ovarian cancer cohort which remains on track to initiate in the first quarter of this year.
    • 18 Mar 2024 Results of Phase 1 analysis reported promising anti-tumor activity of rezatapopt (PC14586) in heavily pre-treated subgroup of patients with advanced ovarian cancer harboring a TP53 Y220C mutation from this trial presented in a PMV Pharmaceuticals media release.
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