A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation.
NCT07372625 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2026-03-12
Summary
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.
Conditions
- TP53 Y220C Mutation
- Advanced Solid Tumors
Interventions
- DRUG
-
metformin hydrochloride 500 mg tablet
500-mg immediate release tablet PO
- DRUG
-
rosuvastatin 10 mg tablet
10-mg tablet PO
- DRUG
-
repaglinide 0.5 mg tablet
0.5-mg tablet PO
- DRUG
-
midazolam hydrochloride syrup
2 mg dose (5-mg/2.5 mL syrup) PO
- DRUG
-
rezatapopt
2000 mg dose (4 x 500-mg tablets) PO
Sponsors & Collaborators
-
SCRI Development Innovations, LLC
collaborator OTHER -
PMV Pharmaceuticals, Inc
lead INDUSTRY
Principal Investigators
-
Vivek Subbiah, MD · SCRI
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-04
- Primary Completion
- 2027-03-31
- Completion
- 2028-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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