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.

Part of paid clinical trials in Denver, Colorado.

Sponsor
PMV Pharmaceuticals, Inc
Study ID
NCT07372625
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors
  • TP53 Y220C Mutation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • metformin hydrochloride 500 mg tablet — DRUG
    500-mg immediate release tablet PO
  • rosuvastatin 10 mg tablet — DRUG
    10-mg tablet PO
  • repaglinide 0.5 mg tablet — DRUG
    0.5-mg tablet PO
  • midazolam hydrochloride syrup — DRUG
    2 mg dose (5-mg/2.5 mL syrup) PO
  • rezatapopt — DRUG
    2000 mg dose (4 x 500-mg tablets) PO

Study Details

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.

Key Dates

Start date
Feb 4, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
14 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A, Days 1-24 and Part B, Cycles 1-33
    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.

Primary Outcome Measure

Metformin Cmax geometric mean ratio [ Time Frame: Day 1 to Day 24 of Part A ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
HealthOne DenverDenverColorado80237
Florida Cancer SpecialistsOrlandoFlorida32827
SCRI Oncology PartnersNashvilleTennessee37203
SCRI at Mary CrowleyDallasTexas75230
NEXT OncologySan AntonioTexas78229

Find similar trials in Denver, CO

By research site
HealthOne Denver· Denver, COFlorida Cancer Specialists· Orlando, FLSCRI Oncology Partners· Nashville, TNSCRI at Mary Crowley· Dallas, TXNEXT Oncology· San Antonio, TX

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