RecruitingPhase 1Phase 2NCT04585750

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

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)


Sponsor

PMV Pharmaceuticals, Inc

Enrollment

300 participants

Start Date

Oct 29, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called rezatapopt (PC14586) in people with advanced or metastatic solid tumors that have a specific genetic change called TP53 Y220C mutation. This mutation makes a protein that normally suppresses cancer growth not work properly, and rezatapopt is designed to fix it. **You may be eligible if...** - You are 18 years old or older (or 12–17 with special committee approval) - Your cancer has been confirmed to have a TP53 Y220C mutation - You have advanced or metastatic cancer that has progressed after at least one prior treatment - You are in good general health (ECOG status 0 or 1) - Your cancer has measurable tumors on imaging **You may NOT be eligible if...** - You have had cancer treatment within 21 days of starting the study - You have a primary brain tumor, brain metastases requiring steroids, or leptomeningeal disease - You have had a heart attack, unstable angina, or congestive heart failure within 6 months - You have had a stroke within 6 months - You have a history of organ transplant - You have active hepatitis B, hepatitis C, or HIV Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGrezatapopt

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

DRUGpembrolizumab

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


Locations(76)

University of California Irvine Chao Family Comprehensive Cancer Center

Irvine, California, United States

University of San Diego Moores Cancer Center

La Jolla, California, United States

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

Medical Oncology Hematology Consultants

Newark, Delaware, United States

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Advent Health

Orlando, Florida, United States

Florida Cancer Specialists South

Port Charlotte, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Columbia University

New York, New York, United States

Memorial Sloan Kettering

New York, New York, United States

Duke University

Durham, North Carolina, United States

The Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

Oregon Health & Science University (OHSU)

Portland, Oregon, United States

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

WellSpan York Cancer Center

York, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

New Experimental Therapeutics - NEXT Oncology

Austin, Texas, United States

UTSW - Moody Outpatient Center - Parkland Health

Dallas, Texas, United States

UT Southwest Simmons Cancer Center

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

New Experimental Therapeutics of San Antonio - NEXT Oncology

San Antonio, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

University of Washington, Fred Hutchinson Cancer Center

Seattle, Washington, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Chris O'Brien Lifehouse Hospital

Camperdown, New South Wales, Australia

Mater Cancer Care Centre

South Brisbane, Queensland, Australia

Flinders Medical Center

Bedford Park, South Australia, Australia

Monash Medical Centre

Clayton, Victoria, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

ICANS - Institut de cancérologie Strasbourg Europe

Strasbourg, Bas-Rhin, France

Institut Bergonie

Bordeaux, Gironde, France

Institut Claudius Regaud

Toulouse, Haute-Garonne, France

EDOG Institut de Cancerologie de l'Ouest

Saint-Herblain, Loire-Atlantique, France

Centre Jean Perrin

Clermont-Ferrand, Puy-de-Dôme, France

Institut Gustave Roussy

Villejuif, Val-de-Marne, France

Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer

Lyon, France

CHU de Nîmes

Nîmes, France

Institute Cancer De Lorraine

Vandœuvre-lès-Nancy, France

Nationale Centrum für Tumorerkrankungen (NCT) Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Universitätsklinikum Augsburg

Augsburg, Bavaria, Germany

Asklepios Klinik Altona

Hamburg, Free and Hanseatic City of Hamburg, Germany

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, Italy

Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori Regina Elena

Rome, Lazio, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Lombardy, Italy

Fondazione IRCCS Istituto Nazionale Dei Tumori

Milan, Lombardy, Italy

Istituto Europeo Di Oncologia

Milan, Lombardy, Italy

Istituto Clinico Humanitas

Rozzano, Lombardy, Italy

Fondazione del Piemonte per l'Oncologia (IRCCS)

Candiolo, Torino, Italy

Humanitas San Pio X

Milan, Italy

IRCCS - lstituto Nazionale Tumori - Fondazione G. Pascale

Naples, Italy

National University Hospital

Kent Ridge, Singapore

National Cancer Center of Singapore

Singapore, Singapore

Asan Medical Center

Seoul, South Korea

National Cancer Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul University Hospital

Seoul, South Korea

Severance Hospital Yonsei University

Seoul, South Korea

START MADRID_Hospital Universitario Fundacion Jimenez Diaz

Madrid, Madrid, Spain

START MADRID_Hospital Universitario HM Sanchinarro - CIOCC

Madrid, Madrid, Spain

Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON

Barcelona, Spain

NEXT Oncology-Hospital Quironsalud Barcelona

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

START Rioja

Rioja, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Sarah Cannon Research Institute UK

London, Middlesex, United Kingdom

Freeman Hospital

Newcastle upon Tyne, Tyne and Wear, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04585750


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