Drugs / rezatapopt
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT07372625 | Feb 2026 → Mar 2027 expected | cancer | PMV Pharmaceuticals, Inc | Recruiting | No outcome recorded |
| Phase 1 | NCT06616636 | Jan 2025 → Aug 2027 expected | acute myeloid leukemia, myelodysplastic syndrome | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06362642 | Mar → Oct 2024 | — | PMV Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT06054464 | Sep → Nov 2023 | — | PMV Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT05523687 | Sep → Nov 2022 | — | PMV Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT05249348 | Dec 2021 → Jun 2022 | — | PMV Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04585750 | Oct 2020 → Dec 2026 expected | HER2 positive breast carcinoma, colorectal cancer, endometrial cancer, gallbladder cancer +8 | PMV Pharmaceuticals, Inc | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-08-31 | PMV Pharmaceuticals, Inc | Results PMV Pharmaceuticals Announces Updated Promising Rezatapopt Monotherapy Interim Ovarian Cancer Data From PYNNACLE Phase 2 Pivotal Trial pmvpharma.com ↗
46% ORR observed among 76 evaluable patients in the ovarian cancer cohort with a median duration of response of 10.0 months |
| 2026-02-26 | PMV Pharmaceuticals, Inc | Results New England Journal of Medicine Publishes First-in-Human Rezatapopt Data Showing Selective Reactivation of Mutant p53 in Advanced Solid Tumors pmvpharma.com ↗
The study published in NEJM entitled, “Phase 1 Study of Rezatapopt, a p53 Reactivator, in TP53 Y220C-Mutated Tumors,” highlighted the antitumor activity of rezatapopt in heavily pretreated patients across multiple solid tumor-types establishing proof-of-concept for p53 reactivation. |
| 2025-10-24 | PMV Pharmaceuticals, Inc | Results PMV Pharmaceuticals Announces Updated Rezatapopt Monotherapy Interim Data From Ongoing PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation pmvpharma.com ↗
PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today announced updated data from the Phase 2 pivotal portion of the ongoing PYNNACLE clinical trial. |
| 2025-09-10 | PMV Pharmaceuticals, Inc | Results PMV Pharmaceuticals Announces Promising Rezatapopt Monotherapy Interim Data From PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation pmvpharma.com ↗
Confirmed responses were observed in patients whose tumors were TP53 Y220C mutated and KRAS wild-type in eight tumor types |
| 2024-10-23 | PMV Pharmaceuticals, Inc | Results PMV Pharmaceuticals Provides a Progress Update on PYNNACLE Clinical Trial pmvpharma.com ↗
rezatapopt 500 mg once-daily in combination with pembrolizumab 200 mg every three weeks established as maximum tolerated dose |
| 2024-03-18 | PMV Pharmaceuticals, Inc | Results PMV Pharmaceuticals PYNNACLE Phase I Data of Rezatapopt in Advanced Ovarian Cancer Featured in Late-Breaking Oral Presentation at 2024 SGO Annual Meeting on Women’s Cancer pmvpharma.com ↗
Of the 15 patients in the efficacy evaluable population, seven patients achieved a confirmed partial response with a seven-month median duration of response and a favorable safety profile |
| 2023-10-12 | PMV Pharmaceuticals, Inc | Results PMV Pharmaceuticals Updated PC14586 Phase 1 Data Demonstrated Anti-Tumor Activity Across Multiple Solid Tumor Types With a TP53 Y220C Mutation pmvpharma.com ↗
today announced updated Phase 1 results from its ongoing Phase 1/2 PYNNACLE clinical trial that showed PC14586 achieved efficacy in heavily pretreated patients across multiple tumor types and was well tolerated with a favorable safety profile. |
| 2022-06-07 | PMV Pharmaceuticals, Inc | Results PMV Pharmaceuticals Initial PC14586 Phase 1 Data Presented at ASCO Demonstrated Anti-Tumor Activity Across Multiple Solid Tumor Types With a p53 Y220C Mutation pmvpharma.com ↗ |
| 2022-05-26 | PMV Pharmaceuticals, Inc | Results PMV Pharmaceuticals Announces Initial PC14586 Phase 1 Clinical Data to be Presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting pmvpharma.com ↗
The published abstract describes preliminary outcomes from 29 patients, including 21 efficacy evaluable, from the ongoing Phase 1/2 PYNNACLE trial of PC14586 in patients with advanced solid tumors that have a p53 Y220C mutation. |
| 2021-04-10 | PMV Pharmaceuticals, Inc | Results PMV Pharma Presents Late-Breaking Preclinical Data on Lead Product Candidate PC14586 at the American Association for Cancer Research Annual Meeting 2021 pmvpharma.com ↗
PC14586 stabilization of the p53 Y220C mutant in the wild-type conformation reactivates p53 activity, which leads to robust tumor regression in mouse xenograft models and has the potential to offer a novel treatment for patients with Y220C genetically defined cancers. |
| 2020-10-13 | PMV Pharmaceuticals, Inc | Regulatory PMV Pharma Granted FDA Fast Track Designation of PC14586 for the Treatment of Advanced Cancer Patients that have Tumors with a p53 Y220C Mutation pmvpharma.com ↗
“Fast Track designation reflects the recognition by the FDA that PC14586 has the potential to address a significant unmet medical need for advanced cancer patients with a p53 Y220C mutation,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. |
All press releases naming this drug 21 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rezatapopt | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07372625 ↗ |
| Known as | PC14586 | “PC14586 (rezatapopt) is a small molecule designed to bind to this pocket and thus restore a p53 wild-type (p53-WT) conformation.” PMID 40608889 ↗ Nov 20255“Rezatapopt (PC14586) is a first-in-class oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation.” NCT07372625 ↗ |
| Action | Restore | “Rezatapopt is an investigational, first-in-class, oral, selective p53 reactivator that specifically binds to Y220C-mutated p53, which stabilizes p53 in its wild-type...” PMID 41740031 ↗ Feb 2026 |
| Modality | Small molecule | “First-in-class, oral, small molecule p53 reactivator selective for the TP53 Y220C mutation.” NCT04585750 ↗ |
| Route | Oral | “Multiple dose levels of daily oral rezatapopt will be evaluated” NCT04585750 ↗ |
| Target | TP53 | “First-in-class, oral, small molecule p53 reactivator selective for the TP53 Y220C mutation.” NCT04585750 ↗ |