PYNNACLE
Research type
Research Study
Full 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)
IRAS ID
1007125
Contact name
Gina Varner
Contact email
Sponsor organisation
PMV Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to test how safe a new drug is, called PC14586. This study consists of two phases. The first phase (Phase 1) is called a “Dose Escalation” phase, which means that different doses are assessed, with increasing doses given to each group of participants over time to find out the maximum dose that can be safely tolerated. The second phase (Phase 2) is called the “Dose Expansion” phase. During Phase 2, a dose selected from Phase 1 that can be safely tolerated will be given to more participants to continue to study how safe and effective it is over time.
Approximately 114 participants will take part in the Phase 2 part of the study across the United States, European Union, United Kingdom, and Asia Pacific.REC name
East of England - Essex Research Ethics Committee
REC reference
24/EE/0019
Date of REC Opinion
21 Mar 2024
REC opinion
Further Information Favourable Opinion