OncRef

Clinical Trial: NCT04585750

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

Status:

RECRUITING

Phase:

Phase 1

Lead Sponsor:PMV Pharmaceuticals, Inc
Information Provided By:PMV Pharmaceuticals, Inc
Last Update Posted:2026-10-02

Study Overview

Brief 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.

Official Title

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)

Conditions

Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer, Metastatic Solid Tumor, Lung Cancer, Ovarian Cancer, Endometrial Cancer, Prostate Cancer, Colorectal Cancer, Breast Cancer, Other Cancer, Locally Advanced, Head and Neck Cancer, Gall Bladder Cancer, Small Cell Lung Cancer, Small Cell Lung Cancer ( SCLC ), Small Cell Lung Carcinoma, NSCLC, NSCLC (Non-small Cell Lung Cancer), SCLC, Non-Small Cell Lung Carcinoma, Triple Negative Breast Cancer, TNBC, HER2+ Breast Cancer, Non-Small Cell Lung Cancer, ER/PR Positive Breast Cancer, HER2- Breast Cancer, HER2-positive Breast Cancer, HER2-negative Breast Cancer, ER/PR(+), Her2(-) Breast Cancer

Intervention / Treatment

  • Drug: rezatapopt
  • Drug: pembrolizumab

Other Study ID Numbers

  • PMV-586-101
  • KEYNOTE-D79
  • MK-3475-D79

Start Date (Actual)

2020-10-29

Primary Completion Date (Estimated)

2026-12-15

Study Completion Date (Estimated)

2027-12-31

Enrollment (Estimated)

300

Study Type

Interventional

Phase

Phase 1, Phase 2