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)


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).

Who Can Join

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a solid tumor that came back or continued to grow despite prior treatment.
  • Patients’ tumors must contain a TP53 mutation called Y220C.
  • At least 3 weeks must pass since the completion of previous cancer treatment (4 weeks since radiation therapy) and receipt of PC14586.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alison Schram at 646-888-5388.




Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory




ClinicalTrials.gov ID