Clinical Trial

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Recruiting Phase 1/2

Record status

This record was last updated August 10, 2026 (before its estimated August 15, 2026 completion). Its status may not reflect the trial's current state.

Summary

The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.

Protocol Amendment History 35 amendments

This ClinicalTrials.gov record has been amended 35 times since 2020-10-07; most recent amendment 2026-06-24.

Status change: Not Yet Recruiting → Recruiting 2020-10-29

Trial Details

NCT Number	NCT04585750
Lead Sponsor	PMV Pharmaceuticals, Inc Collaborators: Merck Sharp & Dohme LLC
Conditions	Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer, Metastatic Solid Tumor, Lung Cancer, Ovarian Cancer, Endometrial Cancer, Prostate Cancer +22 more
Enrollment	300 participants
Start Date	2020-10-29
Primary Completion	2026-08-15 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-10