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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

October 29, 2020

Primary Completion Date

March 17, 2026

Study Completion Date

July 14, 2026

Conditions
Advanced Solid TumorAdvanced Malignant NeoplasmMetastatic CancerMetastatic Solid TumorLung CancerOvarian CancerEndometrial CancerProstate CancerColorectal CancerBreast CancerOther CancerLocally AdvancedHead and Neck CancerGall Bladder CancerSmall Cell Lung CancerSmall Cell Lung Cancer ( SCLC )Small Cell Lung CarcinomaNSCLCNSCLC (Non-small Cell Lung Cancer)SCLCNon-Small Cell Lung CarcinomaTriple Negative Breast CancerTNBCHER2+ Breast CancerNon-Small Cell Lung CancerER/PR Positive Breast CancerHER2- Breast CancerHER2-positive Breast CancerHER2-negative Breast CancerER/PR(+), Her2(-) Breast Cancer
Interventions
DRUG

rezatapopt

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

DRUG

pembrolizumab

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

Trial Locations (82)

10016

WITHDRAWN

New York University Perlmutter Cancer Center, New York

10065

RECRUITING

Memorial Sloan Kettering, New York

11501

WITHDRAWN

New York University - Long Island Hospital, Mineola

15213

NOT_YET_RECRUITING

University of Pittsburgh Medical Center, Pittsburgh

17403

NOT_YET_RECRUITING

WellSpan York Cancer Center, York

19104

RECRUITING

Abramson Cancer Center of the University of Pennsylvania, Philadelphia

19713

RECRUITING

Medical Oncology Hematology Consultants, Newark

22031

RECRUITING

Virginia Cancer Specialists, Fairfax

27705

RECRUITING

Duke University, Durham

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

29425

RECRUITING

Medical University of South Carolina, Charleston

30900

RECRUITING

CHU de Nîmes, Nîmes

32803

NOT_YET_RECRUITING

Advent Health, Orlando

33136

RECRUITING

University of Miami - Sylvester Comprehensive Cancer Center, Miami

33980

RECRUITING

Florida Cancer Specialists South, Port Charlotte

37203

RECRUITING

Sarah Cannon Research Institute, Nashville

37232

WITHDRAWN

Vanderbilt University Medical Center - Ingram Cancer Center, Nashville

44195

RECRUITING

The Cleveland Clinic Taussig Cancer Center, Cleveland

46240

WITHDRAWN

Indiana University, Indianapolis

48201

RECRUITING

Karmanos Cancer Institute, Detroit

53705

RECRUITING

University of Wisconsin Carbone Cancer Center, Madison

54519

RECRUITING

Institute Cancer De Lorraine, Vandœuvre-lès-Nancy

60611

NOT_YET_RECRUITING

Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago

73104

RECRUITING

University of Oklahoma, Oklahoma City

75235

NOT_YET_RECRUITING

UTSW - Moody Outpatient Center - Parkland Health, Dallas

75390

NOT_YET_RECRUITING

UT Southwest Simmons Cancer Center, Dallas

77030

RECRUITING

The University of Texas MD Anderson Cancer Center, Houston

78229

RECRUITING

New Experimental Therapeutics of San Antonio - NEXT Oncology, San Antonio

78705

RECRUITING

New Experimental Therapeutics - NEXT Oncology, Austin

80131

RECRUITING

IRCCS - lstituto Nazionale Tumori - Fondazione G. Pascale, Napoli

80218

RECRUITING

Rocky Mountain Cancer Center, Denver

90024

RECRUITING

UCLA Jonsson Comprehensive Cancer Center, Los Angeles

90033

RECRUITING

USC Norris Comprehensive Cancer Center, Los Angeles

92618

WITHDRAWN

Hoag Cancer Center, Irvine

92868

NOT_YET_RECRUITING

University of California Irvine Chao Family Comprehensive Cancer Center, Irvine

94143

WITHDRAWN

University of San Francisco, San Francisco

97210

RECRUITING

Oregon Health & Science University (OHSU), Portland

98109

RECRUITING

University of Washington, Fred Hutchinson Cancer Center, Seattle

168582

RECRUITING

National Cancer Center of Singapore, Singapore

06519

RECRUITING

Yale Cancer Center, New Haven

02114

RECRUITING

Massachusetts General Hospital, Boston

02215

RECRUITING

Dana Farber Cancer Institute, Boston

98122-

NOT_YET_RECRUITING

Swedish Medical Center, Seattle

Unknown

RECRUITING

Chris O'Brien Lifehouse Hospital, Camperdown

RECRUITING

Mater Cancer Care Centre, South Brisbane

RECRUITING

Flinders Medical Center, Bedford Park

RECRUITING

Monash Medical Centre, Clayton

RECRUITING

Linear Clinical Research, Nedlands

RECRUITING

ICANS - Institut de cancérologie Strasbourg Europe, Strasbourg

RECRUITING

Institut Bergonie, Bordeaux

RECRUITING

Institut Claudius Regaud, Toulouse

RECRUITING

EDOG Institut de Cancerologie de l'Ouest, Saint-Herblain

RECRUITING

Centre Jean Perrin, Clermont-Ferrand

RECRUITING

Institut Gustave Roussy, Villejuif

RECRUITING

Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer, Lyon

RECRUITING

Nationale Centrum für Tumorerkrankungen (NCT) Heidelberg, Heidelberg

RECRUITING

Universitätsklinikum Augsburg, Augsburg

RECRUITING

Asklepios Klinik Altona, Hamburg

RECRUITING

Universitätsklinikum Frankfurt, Frankfurt am Main

RECRUITING

Universitätsklinikum Essen, Essen

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

RECRUITING

Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori Regina Elena, Rome

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda, Milan

RECRUITING

Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan

RECRUITING

Istituto Europeo Di Oncologia, Milan

RECRUITING

Istituto Clinico Humanitas, Rozzano

RECRUITING

Fondazione del Piemonte per l'Oncologia (IRCCS), Candiolo

NOT_YET_RECRUITING

Humanitas San Pio X, Milan

RECRUITING

National University Hospital, Kent Ridge

RECRUITING

Asan Medical Center, Seoul

NOT_YET_RECRUITING

National Cancer Center, Seoul

RECRUITING

Samsung Medical Center, Seoul

RECRUITING

Seoul University Hospital, Seoul

RECRUITING

Severance Hospital Yonsei University, Seoul

RECRUITING

START MADRID_Hospital Universitario Fundacion Jimenez Diaz, Madrid

RECRUITING

START MADRID_Hospital Universitario HM Sanchinarro - CIOCC, Madrid

RECRUITING

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

RECRUITING

NEXT Oncology-Hospital Quironsalud Barcelona, Barcelona

NOT_YET_RECRUITING

START Rioja, Rioja

RECRUITING

Hospital Clinico Universitario de Valencia, Valencia

RECRUITING

Sarah Cannon Research Institute UK, London

RECRUITING

Freeman Hospital, Newcastle upon Tyne

Sponsors
All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

PMV Pharmaceuticals, Inc

INDUSTRY