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: 06 Sep 2024
Price :
$35
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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
- 08 Aug 2024 According to a PMV Pharmaceuticals Media Release, based on a preliminary review of the Phase 1b combination data, KRAS wild-type patients experienced more of a clinical benefit compared to patients with a KRAS single-nucleotide variant (SNV). As a result, PMV has decided to exclude patients with a KRAS SNV from the Phase 1b combination arm in order to maximize the opportunity for patients to benefit from rezatapopt in combination with pembrolizumab.
- 08 Aug 2024 According to a PMV Pharmaceuticals Media Release, enrollment on track for phase 2 more than 60% of sites activated across the U.S., Europe, and Asia-Pacific; interim analysis from Phase 2 monotherapy expected by mid-2025.
- 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.