New pill targets rare cancer mutation in early trial

NCT ID NCT04585750

First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 4 times

Summary

This study tests a new drug called rezatapopt (PC14586) in people with advanced solid tumors that have a specific TP53 Y220C mutation. The drug is designed to reactivate the p53 protein, which normally helps stop cancer growth. The trial will also test rezatapopt combined with the immunotherapy pembrolizumab. About 300 participants will be enrolled to check safety, dosing, and whether the drug shrinks tumors.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
rezatapopt (PC14586) and pembrolizumab
What this could lead to
If successful, this could lead to a new targeted treatment option for people with advanced cancers that have a specific TP53 Y220C mutation, potentially shrinking tumors or slowing disease progression.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not work as hoped or could cause unexpected side effects. The mutation is rare, so results may not apply to most cancer patients.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, Lombardy, Italy

  • Abramson Cancer Center of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Advent Health

    RECRUITING

    Orlando, Florida, 32803, United States

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • Asklepios Klinik Altona

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, Germany

  • CHU de Nîmes

    RECRUITING

    Nîmes, 30900, France

  • Centre Jean Perrin

    RECRUITING

    Clermont-Ferrand, Puy-de-Dôme, France

  • Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer

    RECRUITING

    Lyon, France

  • Chris O'Brien Lifehouse Hospital

    RECRUITING

    Camperdown, New South Wales, Australia

  • Columbia University Medical Center

    NOT_YET_RECRUITING

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27705, United States

  • EDOG Institut de Cancerologie de l'Ouest

    RECRUITING

    Saint-Herblain, Loire-Atlantique, France

  • Flinders Medical Center

    RECRUITING

    Bedford Park, South Australia, Australia

  • Florida Cancer Specialists South

    RECRUITING

    Port Charlotte, Florida, 33980, United States

  • Fondazione IRCCS Istituto Nazionale Dei Tumori

    RECRUITING

    Milan, Lombardy, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Rome, Lazio, Italy

  • Fondazione del Piemonte per l'Oncologia (IRCCS)

    RECRUITING

    Candiolo, Torino, Italy

  • Freeman Hospital

    RECRUITING

    Newcastle upon Tyne, Tyne and Wear, United Kingdom

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Humanitas San Pio X

    RECRUITING

    Milan, Italy

  • ICANS - Institut de cancérologie Strasbourg Europe

    RECRUITING

    Strasbourg, Bas-Rhin, France

  • IRCCS - lstituto Nazionale Tumori - Fondazione G. Pascale

    RECRUITING

    Naples, 80131, Italy

  • Institut Bergonie

    RECRUITING

    Bordeaux, Gironde, France

  • Institut Claudius Regaud

    RECRUITING

    Toulouse, Haute-Garonne, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, Val-de-Marne, France

  • Institute Cancer De Lorraine

    RECRUITING

    Vandœuvre-lès-Nancy, 54519, France

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

    RECRUITING

    Barcelona, Spain

  • Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori Regina Elena

    RECRUITING

    Rome, Lazio, Italy

  • Istituto Clinico Humanitas

    RECRUITING

    Rozzano, Lombardy, Italy

  • Istituto Europeo Di Oncologia

    RECRUITING

    Milan, Lombardy, Italy

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Linear Clinical Research

    RECRUITING

    Nedlands, Western Australia, Australia

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mater Cancer Care Centre

    RECRUITING

    South Brisbane, Queensland, Australia

  • Medical Oncology Hematology Consultants

    RECRUITING

    Newark, Delaware, 19713, United States

  • Medical University of South Carolina

    TERMINATED

    Charleston, South Carolina, 29425, United States

  • Memorial Sloan Kettering

    RECRUITING

    New York, New York, 10065, United States

  • Monash Medical Centre

    RECRUITING

    Clayton, Victoria, Australia

  • NEXT Oncology-Hospital Quironsalud Barcelona

    RECRUITING

    Barcelona, Spain

  • National Cancer Center

    RECRUITING

    Seoul, South Korea

  • National Cancer Center of Singapore

    RECRUITING

    Singapore, 168582, Singapore

  • National University Hospital

    RECRUITING

    Kent Ridge, Singapore

  • Nationale Centrum für Tumorerkrankungen (NCT) Heidelberg

    RECRUITING

    Heidelberg, Baden-Wurttemberg, Germany

  • New Experimental Therapeutics - NEXT Oncology

    RECRUITING

    Austin, Texas, 78705, United States

  • New Experimental Therapeutics of San Antonio - NEXT Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Oregon Health & Science University (OHSU)

    RECRUITING

    Portland, Oregon, 97210, United States

  • Rocky Mountain Cancer Center

    RECRUITING

    Denver, Colorado, 80218, United States

  • START MADRID_Hospital Universitario Fundacion Jimenez Diaz

    RECRUITING

    Madrid, Madrid, Spain

  • START MADRID_Hospital Universitario HM Sanchinarro - CIOCC

    RECRUITING

    Madrid, Madrid, Spain

  • START Rioja

    RECRUITING

    Rioja, Spain

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute UK

    RECRUITING

    London, Middlesex, United Kingdom

  • Seoul University Hospital

    RECRUITING

    Seoul, South Korea

  • Severance Hospital Yonsei University

    RECRUITING

    Seoul, South Korea

  • Texas Oncology

    RECRUITING

    Bedford, Texas, 76022, United States

  • The Cleveland Clinic Taussig Cancer Center

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • UCLA Jonsson Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90024, United States

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • UT Southwest Simmons Cancer Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of California Irvine Chao Family Comprehensive Cancer Center

    WITHDRAWN

    Irvine, California, 92868, United States

  • University of Miami - Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Nebraska Medical Center Buffet Cancer Center

    NOT_YET_RECRUITING

    Omaha, Nebraska, 68105, United States

  • University of Oklahoma

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093, United States

  • University of Washington, Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • University of Wisconsin Carbone Cancer Center

    RECRUITING

    Madison, Wisconsin, 53705, United States

  • Universitätsklinikum Augsburg

    RECRUITING

    Augsburg, Bavaria, Germany

  • Universitätsklinikum Essen

    RECRUITING

    Essen, North Rhine-Westphalia, Germany

  • Universitätsklinikum Frankfurt

    WITHDRAWN

    Frankfurt am Main, Hesse, Germany

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • WellSpan York Cancer Center

    RECRUITING

    York, Pennsylvania, 17403, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06519, United States

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