A Phase 1, Open-label, 2-part, Drug-Drug Interaction Study to Evaluate the Effects of Multiple Oral Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation.
PMV Pharmaceuticals, Inc
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.
Description
Rezatapopt (PC14586) is a first-in-class oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation. This Phase 1, open-label, drug-drug interaction study will investigate the effect of multiple oral doses of rezatapopt on the pharmacokinetics (PK) of metformin, rosuvastatin, repaglinide, and midazolam in patients with advanced solid tumors harboring a TP53 Y220C mutation. This study will consist of 2 parts, Part A and Part B. Part A is a 24-day drug-drug interaction (DDI) portion that follows a fixed- sequence design, including a screening period and 2 treatment peri…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Written informed consent 2. 18 years and older 3. ECOG performance status (PS) score of 0 or 1 4. Confirmed locally advanced or metastatic solid malignancy with a TP53 Y220C mutation identified through a tumor-tissue based (e.g., FoundationOneCDx, PathGroup, Caris WES, MSK IMPACT, TEMPUS) or a liquid-biopsy based (e.g., Caris, MSK Access) NGS molecular test. \- Patients with primary CNS tumors are allowed to enroll 5. Patients with castration-resistant prostate cancer must have ongoing androgen deprivation therapy with a gonadotropin-releasing hormone analog or inhi…
Interventions
- Drugmetformin hydrochloride 500 mg tablet
500-mg immediate release tablet PO
- Drugrosuvastatin 10 mg tablet
10-mg tablet PO
- Drugrepaglinide 0.5 mg tablet
0.5-mg tablet PO
- Drugmidazolam hydrochloride syrup
2 mg dose (5-mg/2.5 mL syrup) PO
- Drugrezatapopt
2000 mg dose (4 x 500-mg tablets) PO
Locations (5)
- HealthOne DenverDenver, Colorado
- Florida Cancer SpecialistsOrlando, Florida
- SCRI Oncology PartnersNashville, Tennessee
- SCRI at Mary CrowleyDallas, Texas
- NEXT OncologySan Antonio, Texas