Rezatapopt for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This study aims to evaluate the effects of rezatapopt on the pharmacokinetics of metformin, rosuvastatin, repaglinide, and midazolam in patients with advanced solid tumors harboring a TP53 Y220C mutation.
Who Is on the Research Team?
Vivek Subbiah, MD
Principal Investigator
SCRI
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors that have a specific genetic change (TP53 Y220C mutation). They should be relatively healthy, able to perform daily activities with ease or minor difficulty, and have their major organs working well. Men with prostate cancer must continue hormone therapy if they join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Patients receive metformin and rosuvastatin, followed by repaglinide and midazolam without rezatapopt
Treatment Period 2
Patients receive rezatapopt with metformin, rosuvastatin, repaglinide, and midazolam
Part B
Continuation of rezatapopt treatment in 21-day cycles up to 2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Rezatapopt
Trial Overview
The study tests how rezatapopt affects the body's handling of four other drugs: metformin, rosuvastatin, repaglinide, and midazolam in syrup form. These patients have a particular gene mutation linked to their cancer and will receive multiple doses of rezatapopt.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients will receive a cocktail of metformin and rosuvastatin after a morning meal on Day 1. Serial PK samples will be collected on Days 1-3. Days 2-5 will serv as a washout period. On Day 2, patients will receive a cocktail of repaglinide and midazolam. Serial PK samples will be collected on Days 2-3. Days 3-5 will serve as a washout period. On Days 6-21 patients will receive rezatapopt with serial PK samples taken on Days 6-7 and sparse PK on Day 14. On Day 22, patients will receive rezatapopt concurrently with a cocktail of metformin and rosuvastatin. Serial PK samples will be collected on Days 22-24. On Day 23, patients will receive rezatapopt concurrently with a cocktail of repaglinide and midazolam. Serial PK samples will be collected on Days 23-24. In Part B, patients will receive rezatapopt as 2000 mg PO QD in 21-day cycles through Cycle 33 (approximately 2 years) or until another discontinuation criterion is met.
Find a Clinic Near You
Who Is Running the Clinical Trial?
PMV Pharmaceuticals, Inc
Lead Sponsor
SCRI Development Innovations, LLC
Collaborator
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