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rezatapopt

DRUG3 trials

Sponsors

PMV Pharmaceuticals, Inc, M.D. Anderson Cancer Center

Conditions

Acute Myeloid LeukemiaAdvanced Malignant NeoplasmAdvanced Solid TumorAdvanced Solid TumorsBreast CancerColorectal CancerER/PR Positive Breast CancerER/PR(+), Her2(-) Breast Cancer

Phase 1

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
RecruitingNCT04585750
PMV Pharmaceuticals, IncAdvanced Malignant Neoplasm, Advanced Solid Tumor, Breast Cancer +27
Start: 2020-10-29End: 2027-12-31Target: 300Updated: 2026-09-15
A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome)
RecruitingNCT06616636
M.D. Anderson Cancer CenterAcute Myeloid Leukemia, Myelodysplastic Syndrome
Start: 2025-01-30End: 2029-08-27Target: 24Updated: 2026-09-11
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.
RecruitingNCT07372625
PMV Pharmaceuticals, IncAdvanced Solid Tumors, TP53 Y220C Mutation
Start: 2026-02-04End: 2028-01-01Target: 14Updated: 2026-08-12

Related Papers

Pivotal PYNNACLE phase 2 trial of rezatapopt in heavily pre-treated, advanced solid tumors with a <i>TP53</i> Y220C mutation: Initial ovarian cancer analysis.
Journal of Clinical Oncology2026-06-23
Restoring p53 wild-type conformation in TP53-Y220C-mutant acute myeloid leukemia.
2025-11-011 citations
PYNNACLE phase II clinical trial protocol: rezatapopt (PC14586) monotherapy in advanced or metastatic solid tumors with a <i>TP53</i> Y220C mutation
Future Oncology2025-09-11
Rezatapopt: A promising small-molecule "refolder" specific for TP53&lt;sup&gt;Y220C&lt;/sup&gt; mutant tumors.
2025-06-20
Abstract P3-12-27: Phase 1 Analysis from the PYNNACLE Phase 1/2 Study of Rezatapopt in the Subgroup of Patients with Advanced Breast Cancer Harboring a TP53 Y220C Mutation
Clinical Cancer Research2025-06-131 citations
PYNNACLE phase 2 clinical trial of rezatapopt in patients with advanced solid tumors harboring a <i>TP53</i> Y220C mutation.
Journal of Clinical Oncology2025-05-28
TP53 Y220C mutations in advanced urothelial bladder cancer (UBC): A genomic landscape study.
Journal of Clinical Oncology2025-02-10
<i>TP53</i> Y220C mutations in pancreatic ductal adenocarcinoma (PDAC): A genomic landscape study.
Journal of Clinical Oncology2025-01-27
Abstract LB_A25: Updated Phase 1 results from the PYNNACLE Phase 1/2 study of PC14586, a selective p53 reactivator, in patients with advanced solid tumors harboring a <i>TP53</i> <i>Y220C</i> mutation
Molecular Cancer Therapeutics2023-12-0110 citations
Selective Targeting of TP53-Y220C Mutant AML By PC14586 Results in TP53 Wild-Type Conformation and Synergistical Apoptosis Induction By Concomitant Inhibition of Xpo-1, MDM2, or Bcl-2
Blood2023-11-0211 citations
First-in-human study of PC14586, a small molecule structural corrector of Y220C mutant p53, in patients with advanced solid tumors harboring a <i>TP53</i> Y220C mutation.
Journal of Clinical Oncology2022-06-0176 citations
Abstract LB006: PC14586: The first orally bioavailable small molecule reactivator of Y220C mutant p53 in clinical development
Cancer Research2021-07-0131 citations