New cancer Drug's interaction with other meds under scrutiny in early trial
NCT ID NCT07372625
First seen Jun 24, 2026 · Last updated Aug 13, 2026 · Updated 3 times
Summary
This early-phase study is looking at how a new drug called rezatapopt affects the way the body processes four common medications (metformin, rosuvastatin, repaglinide, and midazolam) in people with advanced solid tumors that have a specific genetic mutation (TP53 Y220C). The goal is to see if rezatapopt changes the levels of these other drugs in the blood. Only 14 participants will be enrolled, and the study is primarily about safety and drug interactions, not about curing the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rezatapopt
- What this could lead to
- If successful, this study could help doctors understand how rezatapopt interacts with common medications, guiding safer use in future treatments.
- What could go wrong
- This is a very early, small phase 1 trial with only 14 participants. It focuses on drug interactions, not on treating the cancer itself, so it may not lead to direct patient benefits.
Why investors are watching
PMV Pharmaceuticals is testing whether its drug rezatapopt changes how the body processes four common medicines (metformin, rosuvastatin, repaglinide, and midazolam) in patients with advanced solid tumors that have a TP53 Y220C mutation. For a micro-cap company with one main drug candidate, this early-stage interaction study matters because the results will show whether rezatapopt can be safely combined with other drugs patients often take. A clean readout would support the drug's development, while a problematic interaction could complicate its use.
If it works: If the study shows rezatapopt does not meaningfully alter how those four medicines work, the company can argue the drug is easier to manage in real-world patients. That would strengthen the case for moving rezatapopt forward in its clinical program.
If it fails: If the study finds significant drug interactions, doctors may need to adjust doses or avoid certain combinations, which could limit the drug's practical use. Trials at this stage often fail or reveal problems, and a negative result could slow the company's progress and hurt its prospects.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 14 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 inhibitor or orchiectomy (medical or surgical castration) 6. Adequate organ function 7. Life expectancy ≥3 months as assessed by the Investigator Exclusion Criteria: 1. Patients with ovarian, breast, lung, or endometrial tumors who are eligible for the PYNNACLE Phase 2 trial (NCT04585750), unless the corresponding cohort in the PYNNACLE trial is closed to enrollment at the time of screening (to avoid overlap with that study). 2. Treatment, food, or drink with any of the following: * 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 Other protocol-defined inclusion/exclusion criteria may apply
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Florida Cancer Specialists
RECRUITINGOrlando, Florida, 32827, United States
Contact Email: •••••@•••••
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HealthOne Denver
RECRUITINGDenver, Colorado, 80237, United States
Contact Email: •••••@•••••
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NEXT Oncology
RECRUITINGSan Antonio, Texas, 78229, United States
Contact Email: •••••@•••••
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SCRI Oncology Partners
RECRUITINGNashville, Tennessee, 37203, United States
Contact Email: •••••@•••••
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SCRI at Mary Crowley
RECRUITINGDallas, Texas, 75230, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors