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NCT04585750 · ClinicalTrials.gov registry record · Phase 1
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
A Phase 1 study of Breast Cancer and Prostate Cancer, sponsored by PMV Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT04585750: Recruiting Phase 1 study of Breast Cancer and Prostate Cancer, sponsored by PMV Pharmaceuticals.
NCT04585750 is a Phase 1 study of Breast Cancer and Prostate Cancer that is actively recruiting participants, run by PMV Pharmaceuticals. The registered enrollment target is 300 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04585750, a Phase 1 study of Breast Cancer and Prostate Cancer, is actively recruiting participants, sponsored by PMV Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Number of participants with treatment related adverse events
Conditions Studied
Interventions
- DRUG pembrolizumab
- DRUG rezatapopt
Study Locations (20)
California
- University of California Irvine Chao Family Comprehensive Cancer Center - Irvine
- University of San Diego Moores Cancer Center - La Jolla
- UCLA Jonsson Comprehensive Cancer Center - Los Angeles
- USC Norris Comprehensive Cancer Center - Los Angeles
Florida
- University of Miami - Sylvester Comprehensive Cancer Center - Miami
- Advent Health - Orlando
- Florida Cancer Specialists South - Port Charlotte
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
New York
- Columbia University - New York
- Memorial Sloan Kettering - New York
Colorado
- Rocky Mountain Cancer Center - Denver
Connecticut
- Yale Cancer Center - New Haven
Delaware
- Medical Oncology Hematology Consultants - Newark
Michigan
- Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2020-10-29 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT04585750 shows while recruiting
NCT04585750 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower).
The record links to 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which pembrolizumab is the first listed.
NCT04585750 names 20 study sites across 13 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04585750 about?
NCT04585750 is a clinical study titled "The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)". 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, tolera...
What is the current status of trial NCT04585750?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 300 participants. The study started on 2020-10-29. Estimated completion is 2027-12-31.
What conditions does trial NCT04585750 study?
This clinical trial studies the following conditions: Breast Cancer, Prostate Cancer, Lung Cancer, Colorectal Cancer, Ovarian Cancer.
What interventions are being tested in trial NCT04585750?
The interventions under investigation include: pembrolizumab (DRUG), rezatapopt (DRUG).
Who is sponsoring clinical trial NCT04585750?
This trial is sponsored by PMV Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04585750 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04585750's enrollment target sits among peer trials
300 277th of 1224 higher than 938 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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