RecruitingPhase I/IIEN original

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek co najmniej 18 lat (lub 12-17 lat po zgodzie komisji bezpieczeństwa)
  • Zaawansowany lub rozszczepiony nowotwór litego z mutacją TP53 Y220C
  • Ogólny stan zdrowia ECOG 0 lub 1
  • Wcześniejsze leczenie przeciwnowotworowe z progresją choroby
  • Prawidłowe funkcjonowanie organów wewnętrznych
  • Mierzalne ogniska nowotworu (faza 2)
  • Brak wcześniejszego leczenia lekami anty-PD-1/PD-L1 lub progresja po takim leczeniu (faza 1b)
  • Mierzalne ogniska choroby (faza 1b)

✗ Disqualifies

  • Chemioterapia w ciągu 21 dni przed badaniem
  • Radioterapia w ciągu 14 dni przed badaniem
  • Pierwotny nowotwór mózgu
  • Historia zapalenia opon mózgowych lub ucisku rdzenia kręgowego
  • Przerzuty do mózgu, jeśli pacjent wymaga sterydów do ich leczenia
  • Udar lub przemijający zawał mózgu w ciągu 6 miesięcy
  • Choroby serca: niestabilna dławica piersiowa, niekontrolowane nadciśnienie, zawał w ciągu 6 miesięcy, niewydolność serca, arytmie
  • Aktywne zapalenie wątroby typu B lub C lub zakażenie HIV

Simplified criteria — AI translation

Trial details

Minimum age
12 Years
Last updated (source)
June 26, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (77)

University of California Irvine Chao Family Comprehensive Cancer Center

Irvine, United States

University of San Diego Moores Cancer Center

La Jolla, United States

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, United States

USC Norris Comprehensive Cancer Center

Los Angeles, United States

Rocky Mountain Cancer Center

Denver, United States

Yale Cancer Center

New Haven, United States

Medical Oncology Hematology Consultants

Newark, United States

University of Miami - Sylvester Comprehensive Cancer Center

Miami, United States

Advent Health

Orlando, United States

Florida Cancer Specialists South

Port Charlotte, United States

Massachusetts General Hospital

Boston, United States

Dana Farber Cancer Institute

Boston, United States

Karmanos Cancer Institute

Detroit, United States

University of Nebraska Medical Center Buffet Cancer Center

Omaha, United States

Memorial Sloan Kettering

New York, United States

Duke University

Durham, United States

The Cleveland Clinic Taussig Cancer Center

Cleveland, United States

University of Oklahoma

Oklahoma City, United States

Oregon Health & Science University (OHSU)

Portland, United States

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, United States

University of Pittsburgh Medical Center

Pittsburgh, United States

WellSpan York Cancer Center

York, United States

Medical University of South Carolina

Charleston, United States

Sarah Cannon Research Institute

Nashville, United States

New Experimental Therapeutics - NEXT Oncology

Austin, United States

Texas Oncology

Bedford, United States

UTSW - Moody Outpatient Center - Parkland Health

Dallas, United States

UT Southwest Simmons Cancer Center

Dallas, United States

The University of Texas MD Anderson Cancer Center

Houston, United States

New Experimental Therapeutics of San Antonio - NEXT Oncology

San Antonio, United States

Virginia Cancer Specialists

Fairfax, United States

University of Washington, Fred Hutchinson Cancer Center

Seattle, United States

University of Wisconsin Carbone Cancer Center

Madison, United States

Chris O'Brien Lifehouse Hospital

Camperdown, Australia

Mater Cancer Care Centre

South Brisbane, Australia

Flinders Medical Center

Bedford Park, Australia

Monash Medical Centre

Clayton, Australia

Linear Clinical Research

Nedlands, Australia

ICANS - Institut de cancérologie Strasbourg Europe

Strasbourg, France

Institut Bergonie

Bordeaux, France

Institut Claudius Regaud

Toulouse, France

EDOG Institut de Cancerologie de l'Ouest

Saint-Herblain, France

Centre Jean Perrin

Clermont-Ferrand, France

Institut Gustave Roussy

Villejuif, 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, Germany

Universitätsklinikum Augsburg

Augsburg, Germany

Asklepios Klinik Altona

Hamburg, Germany

Universitätsklinikum Frankfurt

Frankfurt am Main, Germany

Universitätsklinikum Essen

Essen, Germany

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori Regina Elena

Rome, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Fondazione IRCCS Istituto Nazionale Dei Tumori

Milan, Italy

Istituto Europeo Di Oncologia

Milan, Italy

Istituto Clinico Humanitas

Rozzano, Italy

Fondazione del Piemonte per l'Oncologia (IRCCS)

Candiolo, 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, Spain

START MADRID_Hospital Universitario HM Sanchinarro - CIOCC

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, United Kingdom

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Trial contact

PMV Pharma Clinical Study Information Center

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.