Actively Recruiting
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.
Led by PMV Pharmaceuticals, Inc · Updated on 2026-03-12
14
Participants Needed
5
Research Sites
99 weeks
Total Duration
On this page
Sponsors
P
PMV Pharmaceuticals, Inc
Lead Sponsor
S
SCRI Development Innovations, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- 18 years of age or older
- ECOG performance status of 0 or 1
- Confirmed locally advanced or metastatic solid tumor with TP53 Y220C mutation by tumor tissue or liquid biopsy
- Patients with primary CNS tumors are eligible
- Patients with castration-resistant prostate cancer must be on ongoing androgen deprivation therapy
- Adequate organ function
- Life expectancy of at least 3 months as judged by Investigator
You will not qualify if you...
- Patients with ovarian, breast, lung, or endometrial tumors eligible for the PYNNACLE Phase 2 trial unless that cohort is closed
- Use of systemic anticancer therapies or investigational agents within 21 days or 5 half-lives prior to first study dose
- Radiotherapy within 14 days of first study dose except limited palliative or stereotactic body radiation to non-target lesions
- Use of inhibitors or inducers of enzymes and transporters tested in study within 14 days of study start
- Use of sensitive CYP3A4 or CYP2C8 substrates with narrow therapeutic index within 14 days
- Use of herbal medicines known to strongly affect CYP3A4 within 14 days
- Consumption of foods or drinks with CYP3A inhibition potential within 14 days
- Known allergy or intolerance to rezatapopt, metformin, rosuvastatin, repaglinide, midazolam, or similar substances
- Untreated brain metastases, leptomeningeal metastases, or spinal cord compression; prior treated brain metastases allowed if stable and >4 weeks
- Stroke or transient ischemic attack within 6 months before screening
- Uncontrolled or significant heart diseases including QTcF >470 msec or uncontrolled hypertension
- Active gastrointestinal diseases affecting drug absorption or metabolism
- History of organ transplant
- Other active invasive cancers within 2 years except certain treated local tumors
- Active uncontrolled hepatitis B, hepatitis C, or HIV infections
- Known KRAS single-nucleotide variation mutation
- Major surgery within 4 weeks of first study dose except vascular access placement
Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
HealthOne Denver
Denver, Colorado, United States, 80237
Actively Recruiting
2
Florida Cancer Specialists
Orlando, Florida, United States, 32827
Actively Recruiting
3
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
4
SCRI at Mary Crowley
Dallas, Texas, United States, 75230
Actively Recruiting
5
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
S
SCRI Medical Support Center
CONTACT
P
PMV Pharma Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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