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Rezatapopt Study for Advanced Solid Tumors with TP53 Y220C Mutation

This study is looking at how a drug called rezatapopt affects other common medications like metformin, rosuvastatin, repaglinide, and midazolam in people with advanced solid tumors that have a specific genetic change called a TP53 Y220C mutation. Rezatapopt is designed to reactivate a certain protein (p53) that helps fight cancer. Researchers want to see if rezatapopt changes how much of these other medications stay in your body. To join, you must be at least 18 years old, have a good performance status (meaning you can do most daily activities), and have advanced solid tumors with the TP53 Y220C mutation confirmed by a genetic test. The study plans to enroll 14 participants, but its current status is unclear.

Study design
This is an open-label study, meaning you and your doctors will know which treatments you are receiving. It will involve 14 participants and is designed to look at drug interactions.
What's involved
You will receive metformin, rosuvastatin, repaglinide, and midazolam, both with and without rezatapopt, over a 24-day period. Blood samples will be collected on specific days to measure drug levels.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at Day 1 to Day 24 of Part A. If you complete Part A and are still benefiting, you may continue rezatapopt treatment in Part B.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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.

Recruiting
PHASE1Ages 18+InterventionalTreatment
PMV Pharmaceuticals, Inc
~14 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:metformin hydrochloride 500 mg tabletrosuvastatin 10 mg tabletrepaglinide 0.5 mg tabletmidazolam hydrochloride syruprezatapopt

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Metformin Cmax geometric mean ratio
Measured over Day 1 to Day 24 of Part A
+17 more outcomes measured

Conditions

TP53 Y220C Mutation
Advanced Solid Tumors

Explore related trials

Solid NeoplasmTP53 Gene

Where it's being run

5 sites across 4 states
Texas2
Colorado1
Florida1
Tennessee1

Study leadership

  • Deepak Bhamidipati, MD · STUDY_CHAIR · SCRI

Who to contact

SCRI Medical Support Center
[email protected]
1-615-329-7286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Any systemic anticancer therapies, including but not limited to chemotherapy, small molecule, biologic, or hormonal agents from a previous treatment regimen, or investigational anticancer agents from clinical study within 21 days or 5 half-lives (whichever is longer) prior to the first dose of study drugs
Radiotherapy within 14 days of first dose of study drugs. Palliative radiotherapy particularly limited field and stereotactic body radiation therapy to non-target lesions should be allowed.
Inhibitors or inducers of the enzymes and transporters being tested in this study within 14 days of starting study drugs
Sensitive substrates of CYP3A4 or CYP2C8 with a narrow therapeutic index within 14 days of starting study drugs
Herbal preparations/medications known to be strong or moderate CYP3A4 inhibitors or inducers or to have other significant potential for interaction with rezatapopt within 14 days of starting study drugs
Foods or drinks with CYP3A inhibition potential (e.g., grapefruit, grapefruit juice, Seville orange juice, pomelos, starfruits) within 14 days of starting study drugs 3. Known or suspected significant hypersensitivity, intolerance, or allergy to rezatapopt, metformin, rosuvastatin, repaglinide, or midazolam or any of their excipients or medicinal products with similar chemical structures, food, or other substances 4. Previously untreated brain metastases, leptomeningeal metastases, or spinal cord compression due to disease. Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 4 weeks prior to starting study drugs, there is no evidence of central nervous system disease progression or mild neurologic symptoms, and there is no requirement for chronic corticosteroid therapy. 5. Stroke or transient ischemic attack within 6 months before screening 6. Clinically significant, uncontrolled heart diseases currently or within the last 6 months including:
QTcF \>470 msec obtained as the mean from 3 consecutive resting ECGs. A QTcF value corrected for wide QRS \>120 msec (QTcFBBB) should be used in place of QTcF for patients with non-clinically significant wide QRS \>120 msec due to a pacemaker or bundle branch block.
Uncontrolled hypertension 7. Active gastrointestinal disease that may interfere significantly with the absorption, distribution, metabolism, or excretion of study drug 8. History of prior organ transplant 9. Presence of other active invasive cancers other than the one treated in this study within 2 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix, or other local tumors considered cured by local treatment 10. Known, active, uncontrolled hepatitis B virus infection (i.e., viral load above the limit of quantification), hepatitis C virus infection (i.e., viral load above the limit of quantification), or human immunodeficiency virus infection (viral load \>400 copies/mL of blood). Patients whose viral load is controlled should be on established antiretroviral therapy for at least 4 weeks before receiving their first dose of study drugs. 11. Patients with a known KRAS single-nucleotide variation (SNV) mutation 12. Major surgery (excluding placement of vascular access) within 4 weeks of first dose of study drugs

What this trial measures

  • Metformin Cmax geometric mean ratioDay 1 to Day 24 of Part A

    Geometric mean metformin peak concentration (Cmax) when administered with rezatapopt versus metformin alone.

  • Rosuvastatin Cmax geometric mean ratioDay 1 to Day 24 of Part A

    Geometric mean rosuvastatin peak concentration (Cmax) when administered with rezatapopt versus rosuvastatin alone.

  • Repaglinide Cmax geometric mean ratioDay 1 to Day 24 of Part A

    Geometric mean repaglinide peak concentration (Cmax) when administered with rezatapopt versus repaglinide alone

  • Midazolam Cmax geometric mean ratioDay 1 to Day 24 of Part A

    Geometric mean midazolam peak concentration (Cmax) when administered with rezatapopt versus midazolam alone

  • Metformin AUC0-t geometric mean ratioDay 1 to Day 24 of Part A

    Geometric mean metformin area under the concentration-time curve from pre-dose (time 0) to t post-dose (AUC0-t) when administered with rezatapopt versus metformin alone

  • Rosuvastatin AUC0-t geometric mean ratioDay 1 to Day 24 of Part A

    Geometric mean rosuvastatin area under the concentration-time curve from pre-dose (time 0) to t post-dose (AUC0-t) when administered with rezatapopt versus rosuvastatin alone

  • Repaglinide AUC0-t geometric mean ratioDay 1 to Day 24 of Part A

    Geometric mean repaglinide area under the concentration-time curve from pre-dose (time 0) to t post-dose (AUC0-t) when administered with rezatapopt versus repaglinide alone

  • Midazolam AUC0-t geometric mean ratioDay 1 to Day 24 of Part A

    Geometric mean midazolam area under the concentration-time curve from pre-dose (time 0) to t post-dose (AUC0-t) when administered with rezatapopt versus midazolam alone

  • PK profile of metformin - area under the concentration-time curve from pre-dose (time 0) to 24 h post-dose (AUC0-24)Day 1 to Day 24 of Part A

    Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of metformin

  • PK profile of rosuvastatin - area under the concentration-time curve from pre-dose (time 0) to 24 h post-dose (AUC0-24)Day 1 to Day 24 of Part A

    Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rosuvastatin

  • PK profile of repaglinide - area under the concentration-time curve from pre-dose (time 0) to 24 h post-dose (AUC0-24)Day 1 to Day 24 of Part A

    Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of repaglinide

  • PK profile of midazolam - area under the concentration-time curve from pre-dose (time 0) to the time 24 h post-dose (AUC0-24)Day 1 to Day 24 of Part A

    Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of midazolam

  • PK profile of metformin - area under the concentration-time curve from pre-dose (time 0) to 48 h post-dose (AUC0-48)Day 1 to Day 24 of Part A

    Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of metformin

  • PK profile of rosuvastatin - area under the concentration-time curve from pre-dose (time 0) to 48 h post-dose (AUC0-48)Day 1 to Day 24 of Part A

    Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rosuvastatin

  • PK Profile of Metformin - Time of Peak Concentration (Tmax)Day 1 to Day 24 of Part A

    Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of metformin

  • PK Profile of Rosuvastatin - Time of Peak Concentration (Tmax)Day 1 to Day 24 of Part A

    Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rosuvastatin

  • PK Profile of Repaglinide - Time of Peak Concentration (Tmax)Day 1 to Day 24 of Part A

    Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of repaglinide

  • PK Profile of Midazolam - Time of Peak Concentration (Tmax)Day 1 to Day 24 of Part A

    Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of midazolam