A Ph 1/2 of PC14586 in Patients with Advanced or Metastatic Tumors w/ TP53 Y220C Mutation

What is the Purpose of this Study?

If you decide to participate in this study, you will have a screening visit to see if you meet the criteria to be included in this study. If you are eligible, you will proceed to the study drug period. During this period, you will:

  • Take the study drug tablets by mouth at about the same time each morning and within 30 minutes of finishing your breakfast for the first 15 days
  • After the first 15 days, continue to take the study drug by mouth at approximately the same time every day, within 30 minutes of finishing a meal (breakfast, lunch, or dinner) of your choice

The following tests and procedures will be performed throughout the study:

  • Blood draws
  • Imaging tests (CT, PET/CT and MRI)
  • ECG
What is the Condition Being Studied?

Locally Advanced or Metastatic Solid Tumors with a TP53 Y220C Mutation

Who Can Participate in the Study?

Adults ages 18+ who:

  • Have a confirmed locally advanced or metastatic solid malignancy with a TP53 Y220C mutation
  • Have received prior standard therapy appropriate for their tumor type and stage of disease and have documented progression

For more information about who can join this study, please contact the study team at 919-668-6342.

Age Group
Adults

What is Involved?

We are doing this study to find the most effective, safe dose of an experimental drug called PC14586, in people with locally advanced or metastatic solid tumors with a TP53 Y220C mutation.

Study Details

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)
Principal Investigator
Associate Professor of Medicine
Protocol Number
IRB: PRO00115807
NCT: NCT04585750
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF