The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
Public ClinicalTrials.gov record NCT04585750. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04585750
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 300 participants
Conditions and interventions
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
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 28, 2020
- Primary completion
- Aug 14, 2026
- Completion
- Dec 30, 2027
- Last update posted
- Aug 9, 2026
2020 – 2027
United States locations
- U.S. sites
- 33
- U.S. states
- 20
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California Irvine Chao Family Comprehensive Cancer Center | Irvine | California | 92868 | Withdrawn |
| University of San Diego Moores Cancer Center | La Jolla | California | 92093 | Recruiting |
| UCLA Jonsson Comprehensive Cancer Center | Los Angeles | California | 90024 | Recruiting |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Recruiting |
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | Recruiting |
| Yale Cancer Center | New Haven | Connecticut | 06519 | Recruiting |
| Medical Oncology Hematology Consultants | Newark | Delaware | 19713 | Recruiting |
| University of Miami - Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | Recruiting |
| Advent Health | Orlando | Florida | 32803 | Recruiting |
| Florida Cancer Specialists South | Port Charlotte | Florida | 33980 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | Recruiting |
| University of Nebraska Medical Center Buffet Cancer Center | Omaha | Nebraska | 68105 | Not yet recruiting |
| Columbia University Medical Center | New York | New York | 10032 | Not yet recruiting |
| Memorial Sloan Kettering | New York | New York | 10065 | Recruiting |
| Duke University | Durham | North Carolina | 27705 | Recruiting |
| The Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | Recruiting |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Oregon Health & Science University (OHSU) | Portland | Oregon | 97210 | Recruiting |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Recruiting |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | Recruiting |
| WellSpan York Cancer Center | York | Pennsylvania | 17403 | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Terminated |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | Recruiting |
| New Experimental Therapeutics - NEXT Oncology | Austin | Texas | 78705 | Recruiting |
| Texas Oncology | Bedford | Texas | 76022 | Recruiting |
| UT Southwest Simmons Cancer Center | Dallas | Texas | 75390 | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| New Experimental Therapeutics of San Antonio - NEXT Oncology | San Antonio | Texas | 78229 | Recruiting |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | Recruiting |
| University of Washington, Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | Recruiting |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53705 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 44 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04585750, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 9, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04585750 live on ClinicalTrials.gov.