Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07372625

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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