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rezatapopt / Advanced Malignant Neoplasm / Advanced Solid Tumor · Phase 1/2 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a prospective, multi-arm Phase 1/2 trial evaluating rezatapopt (PC14586) as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors bearing TP53 Y220C mutations. The trial is currently recruiting and has not yet reported efficacy or safety results; no conclusions about clinical benefit can be drawn from this registry entry alone.
Phase 1/2, Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer, Metastatic Solid Tumor, Lung Cancer, Ovarian Cancer, Endometrial Cancer, Prostate Cancer,…; age from 12 Years. Intervention: Phase 1 Monotherapy Dose Escalation; Phase 1b Combination Therapy Dose Escalation, Part 1; Phase 1b Combination Therapy Dose Expansion, PD(L)-1 naive…; Phase 1b Combination Therapy Dose Expansion, PD(L)-1 relaps…; Phase 2 Monotherapy Dose…. n = 300. 77 sites across 9 countries.
This is a prospective, multi-arm Phase 1/2 trial evaluating rezatapopt (PC14586) as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors bearing TP53 Y220C mutations. The trial is currently recruiting and has not yet reported efficacy or safety results; no conclusions about clinical benefit can be drawn from this registry entry alone.
Primary endpoints are safety and dose-finding; efficacy data (response rate) are secondary Phase 2 readouts not yet reported. Timeline shows variable follow-up durations (12–40 months) across arms; mature efficacy and safety data are not yet available.
This trial is in active recruitment phase and designed to establish the safety profile and recommended dose of rezatapopt, a TP53 Y220C–selective reactivator, in a molecularly defined patient population. Clinicians should await Phase 2 efficacy results before considering this agent in clinical practice.
This is an active clinical trial registry record with no reported results; Phase 1/2 design studying an investigational drug in a molecularly defined population with safety and dose-finding as primary objectives.
As stated by the source record.
Quoted from the source exactly as published.
This trial is in active recruitment phase and designed to establish the safety profile and recommended dose of rezatapopt, a TP53 Y220C–selective reactivator, in a molecularly defined patient population. Clinicians should await Phase 2 efficacy results before considering this agent in clinical practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04585750). This is a study registration, not published results. Lead sponsor: PMV Pharmaceuticals, Inc. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer, Metastatic Solid Tumor, Lung Cancer, Ovarian Cancer, Endometrial Cancer, Prostate Cancer, Colorectal Cancer, Breast Cancer, Other Cancer, Locally Advanced, Head and Neck Cancer, Gall Bladder Cancer, Small Cell Lung Cancer, Small Cell Lung Cancer ( SCLC ), Small Cell Lung Carcinoma, NSCLC, NSCLC (Non-small Cell Lung Cancer), SCLC, Non-Small Cell Lung Carcinoma, Triple Negative Breast Cancer, TNBC, HER2+ Breast Cancer, Non-Small Cell Lung Cancer, ER/PR Positive Breast Cancer, HER2- Breast Cancer, HER2-positive Breast Cancer, HER2-negative Breast Cancer, ER/PR(+), Her2(-) Breast Cancer. Interventions: DRUG: rezatapopt; DRUG: pembrolizumab. Primary outcome measures: Phase 1 Monotherapy (Dose Escalation): Determine the number and type of adverse events to characterize the safety of rezatapopt , 40 months; Phase 1 Monotherapy (Dose Escalation): Establish the Recommended Phase 2 Dose (RP2D) , 30 months; Phase 1 Monotherapy (Dose Escalation): Establish the maximum tolerated dose (MTD) (Phase 1) , The first 28 days of treatment (Cycle 1) per patient; Phase 1b Combination Therapy (Part 1: Dose Escalation): Determine the number and type of adverse events to characterize the safety of rezatapopt when administered in combination with pembrolizumab , 18 months for treatment arm; Phase 1b Combination Therapy (Part 1: Dose Escalation): Establish the maximum tolerated dose (MTD) of rezatapopt when administered in combination with pembrolizumab , The first 28 days of combination treatment arm (starting on Day -7) per patient; Phase 1b Combination Therapy (Part 1: Dose Escalation): Establish the Recommended Phase 2 Dose (RP2D) of rezatapopt when administered in combination with pembrolizumab , 18 months; Phase 1b Combination Therapy (Part 2: Dose Expansion): Determine the number and type of adverse events to characterize the safety of rezatapopt when administered in combination with pembrolizumab , 12 months for treatment arm; Phase 2 Monotherapy (Dose Expansion): Response rate assessment to evaluate the clinical activity / efficacy of rezatapopt , 34 months; Phase 2 Monotherapy (Dose Expansion): Response rate assessment to evaluate the clinical activity / efficacy of rezatapopt in ovarian cancer patients , 34 months. Brief summary: The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.