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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 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.

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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.

Conditions Studied

Breast Cancer Prostate Cancer Lung Cancer Colorectal Cancer Ovarian Cancer Advanced Solid Tumor Endometrial Cancer Metastatic Cancer Metastatic Solid Tumor Advanced Malignant Neoplasm

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

FieldValue
Enrollment Target 300 participants
Start Date 2020-10-29
Est. Completion 2027-12-31
Phase Phase 1

Sponsor

PMV Pharmaceuticals

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04585750

The ClinicalTrials.gov registry entry for NCT04585750 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower). The listed sponsor is PMV Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.