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
- Blood draws
- Imaging tests (CT, PET/CT and MRI)
- ECG
Who Can Participate?
Eligibility
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
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
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
Niharika
Mettu
Protocol Number
PRO00115807
NCT ID
NCT04585750
Phase
I/II
Enrollment Status
Pending Open to Enrollment