The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
← catalyst calendarSponsored by PMV Pharmaceuticals, Inc (industry) · PMVP — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
300estimated
Sites
77
Countries
Australia, France, Germany +6
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-10-29 | actual | When the study began enrolling |
| Primary completion | 2026-08-15 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2020-10-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
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 — also filed as PC14586
- Drug: pembrolizumab — also filed as KEYTRUDA®, MK-3475, KEYNOTE-D79, MK-3475-D79
Primary outcomes
what the primary-completion date above is the date OFPhase 1 Monotherapy (Dose Escalation): Determine the number and type of adverse events to characterize the safety of rezatapopt
measured 40 months
Phase 1 Monotherapy (Dose Escalation): Establish the Recommended Phase 2 Dose (RP2D)
measured 30 months
Phase 1 Monotherapy (Dose Escalation): Establish the maximum tolerated dose (MTD) (Phase 1)
measured 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
measured 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
measured 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
measured 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
measured 12 months for treatment arm
Phase 2 Monotherapy (Dose Expansion): Response rate assessment to evaluate the clinical activity / efficacy of rezatapopt
measured 34 months
Phase 2 Monotherapy (Dose Expansion): Response rate assessment to evaluate the clinical activity / efficacy of rezatapopt in ovarian cancer patients
measured 34 months
Publications
- PMID 41740031 — linked by the registry
- PMID 40932470 — linked by the registry
- PMID 40543428 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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