A Phase I/II Study of PC14586 in People with Solid Tumors Containing a p53 Y220C Mutation

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)

Purpose

The purpose of this study is to find the highest dose of the investigational drug PC14586 that can be given in patients with solid tumors that came back or continue to grow despite prior therapy and contain a mutation in the TP53 gene. The p53 protein produced by this gene normally tells cells when to stop dividing, but when TP53 is altered (mutated), cancer may result.

PC14586 may be able to restore normal activity to the mutated p53 Y220C protein in cancer cells. By reactivating mutated p53 Y220C, PC14586 may be able to slow the growth of cancer cells and stop the spread of cancer. PC14586 is taken orally (by mouth).