CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 300 target
Drug / intervention
rezatapopt +1 moredrug
Likely dose
pembrolizumab 200 mgfrom record
Key inclusion· 8
  • ✓Age 18+ (or 12-17 with SRC approval)
  • ✓Locally advanced or metastatic solid malignancy with TP53 Y220C mutation
  • ✓ECOG status 0 or 1
  • ✓Prior anticancer therapy with progressive disease
Key exclusion· 22
  • ✕Anticancer therapy within 21 days or 5 half-lives of study drug
  • ✕Radiotherapy within 14 days of study drug
  • ✕Primary CNS tumor
  • ✕Leptomeningeal disease or spinal cord compression history

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

In the news

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Matched to this trial by ClinicalIndexfrom reputable biotech & medical press.

Search/NCT04585750
NCT04585750Phase 1RecruitingHigh Momentum
Long Recruiting
CompareCT.gov

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

PMV Pharmaceuticals, Inc·interventional·Posted Oct 14, 2020·Updated Jun 26, 2026

In Brief

A Phase 1 clinical trial evaluating rezatapopt and pembrolizumab for Advanced Solid Tumor and 29 related conditions. Currently recruiting, targeting 300 participants across 77 sites in 9 countries.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced 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
CountriesAustralia, France, Germany, Italy, Singapore, South Korea, Spain, United Kingdom, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 1Recruiting
20212022202320242025202620272028
First PostedOct 14, 2020
Enrollment StartOct 29, 2020
Primary CompletionAug 15, 2026
Study CompletionDec 31, 2027
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 5.7 years agoPrimary completion in 1 month

Arms & Interventions

Phase 1 Monotherapy Dose Escalationexperimental

Multiple dose levels of daily oral rezatapopt will be evaluated in an escalating manner, to determine the maximum tolerated dose and to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of rezatapopt to recommend a Phase 2 dose (RP2D).

Drug: rezatapopt
Phase 1b Combination Therapy Dose Escalation, Part 1experimental

Multiple dose levels of daily oral rezatapopt in combination with a stable dose of pembrolizumab (200 mg IV q3 weeks) will be evaluated in an escalating manner, to determine the maximum tolerated dose and to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of PC14586 to recommend a Phase 2 dose (RP2D) of rezatapopt when administered in combination with pembrolizumab.

Drug: rezatapoptDrug: pembrolizumab
Phase 1b Combination Therapy Dose Expansion, PD(L)-1 naive patientsexperimental

Additional (expansion of) participants will enroll at the RP2D of daily oral PC14586 (INN: rezatapopt) when administered in combination with pembrolizumab (200 mg IV q3 weeks) for continued evaluation. Participants will have advanced solid tumors harboring a p53 Y220C mutation and are PD(L)-1 naive patients.

Drug: rezatapoptDrug: pembrolizumab
Phase 1b Combination Therapy Dose Expansion, PD(L)-1 relapsed/refractory patientsexperimental

Additional (expansion of) participants will enroll at the RP2D of daily oral rezatapopt when administered in combination with pembrolizumab (200 mg IV q3 weeks) for continued evaluation. Participants will have advanced solid tumors harboring a p53 Y220C mutation and are PD(L)-1 relapsed/refractory patients.

Drug: rezatapoptDrug: pembrolizumab
Phase 2 Monotherapy Dose Expansion, Ovarian Cancer Cohortexperimental

Additional (expansion of) participants will dose with 2000 mg daily oral PC14586 (INN: rezatapopt) with food for continued evaluation. Ovarian Cancer Cohort participants will have locally advanced or metastatic ovarian cancer harboring a TP53 Y220C mutation who meet all eligibility criteria and have measurable disease per RECIST 1.1.

Drug: rezatapopt
Phase 2 Monotherapy Dose Expansion, Lung Cancer Cohortexperimental

Additional (expansion of) participants will dose with 2000 mg daily oral PC14586 (INN: rezatapopt) with food for continued evaluation. Lung Cancer Cohort participants will have locally advanced or metastatic lung cancer harboring a TP53 Y220C mutation who meet all eligibility criteria and have measurable disease per RECIST 1.1.

Drug: rezatapopt
Phase 2 Monotherapy Dose Expansion, Breast Cancer Cohortexperimental

Additional (expansion of) participants will dose with 2000 mg daily oral PC14586 (INN: rezatapopt) with food for continued evaluation. Breast Cancer Cohort participants will have locally advanced or metastatic breast cancer harboring a TP53 Y220C mutation who meet all eligibility criteria and have measurable disease per RECIST 1.1.

Drug: rezatapopt
Phase 2 Monotherapy Dose Expansion, Endometrial Cancer Cohortexperimental

Additional (expansion of) participants will dose with 2000 mg daily oral PC14586 (INN: rezatapopt) with food for continued evaluation. Endometrial Cancer Cohort participants will have locally advanced or metastatic endometrial cancer harboring a TP53 Y220C mutation who meet all eligibility criteria and have measurable disease per RECIST 1.1.

Drug: rezatapopt
Phase 2 Monotherapy Dose Expansion, Other Solid Tumors Cohortexperimental

Additional (expansion of) participants will dose with 2000 mg daily oral PC14586 (INN: rezatapopt) with food for continued evaluation. Other Solid Tumors Cohort participants will have locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation who meet all eligibility criteria and have measurable disease per RECIST 1.1.

Drug: rezatapopt

Interventions

rezatapoptdrug

First-in-class, oral, small molecule p53 reactivator selective for the TP53 Y220C mutation.

pembrolizumabdrug

Participants receive pembrolizumab 200 mg by intravenous (IV) infusion over 30 minutes.