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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: PMV Pharmaceuticals, Inc • ClinicalTrials.gov ID: NCT04585750

Registry updated: 2026-10-02
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Description

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.

Interventions

  • rezatapopt (Drug)
    First-in-class, oral, small molecule p53 reactivator selective for the TP53 Y220C mutation.
  • pembrolizumab (Drug)
    Participants receive pembrolizumab 200 mg by intravenous (IV) infusion over 30 minutes.

Eligibility criteria

Inclusion Criteria: * At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval. * Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation * Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 * Previously treated with one or more lines of anticancer therapy and progressive disease * Adequate organ function * Measurable disease per RECIST v1.1 (Phase 2) Additional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination) * Anti-PD-1/PD-L1 naive or must have progressed on treatment * Measurable disease Exclusion Criteria: * Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug * Radiotherapy within 14 days of receiving the study drug * Primary CNS tumor * History of leptomeningeal disease or spinal cord compression * Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms * Stroke or transient ischemic attack within 6 months prior to screening * Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities * Strong CYP3A4 inducers and strong CYP2C9 inhibitors/inducers within 14 days of first dose of rezatapopt * History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication * History of prior organ transplant * Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer * Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection Additional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy) * Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2). Exception: Ovarian cancer patients with a known KRAS SNV are permitted. Additional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination) * Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE) * Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention * Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug * Hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients * Active autoimmune disease that has required systemic treatment in past 2 years * History of radiation pneumonitis * History of (non-infectious) or active pneumonitis / interstitial lung disease that required steroids * Active infection requiring systemic therapy * Known history of HIV infection * Has previously received rezatapopt

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

Locations

  • 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 Medical Center — 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
  • Texas Oncology — Bedford, 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record