Eligibility
Caution: ClinicalTrials.gov appears to have newer eligibility criteria than the version saved here. Review the current criteria in ClinicalTrials.gov.
Show 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 28 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, 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
* 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)
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
Sites (76)
Sort by distance to:
Chris O'Brien Lifehouse Hospital
Camperdown, New South Wales, Australia
No email / No phone
Status: Recruiting
Mater Cancer Care Centre
South Brisbane, Queensland, Australia
No email / No phone
Status: Recruiting
Flinders Medical Center
Bedford Park, South Australia, Australia
No email / No phone
Status: Recruiting
Monash Medical Centre
Clayton, Victoria, Australia
No email / No phone
Status: Recruiting
Linear Clinical Research
Nedlands, Western Australia, Australia
No email / No phone
Status: Recruiting
CHU de Nîmes
Nîmes, 30900, France
No email / No phone
Status: Recruiting
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer
Lyon, France
No email / No phone
Status: Recruiting
Institute Cancer De Lorraine
Vandœuvre-lès-Nancy, 54519, France
No email / No phone
Status: Recruiting
ICANS - Institut de cancérologie Strasbourg Europe
Strasbourg, Bas-Rhin, France
No email / No phone
Status: Recruiting
Institut Bergonie
Bordeaux, Gironde, France
No email / No phone
Status: Recruiting
Institut Claudius Regaud
Toulouse, Haute-Garonne, France
No email / No phone
Status: Recruiting
EDOG Institut de Cancerologie de l'Ouest
Saint-Herblain, Loire-Atlantique, France
No email / No phone
Status: Recruiting
Centre Jean Perrin
Clermont-Ferrand, Puy-de-Dôme, France
No email / No phone
Status: Recruiting
Institut Gustave Roussy
Villejuif, Val-de-Marne, France
No email / No phone
Status: Recruiting
Nationale Centrum für Tumorerkrankungen (NCT) Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
No email / No phone
Status: Recruiting
Universitätsklinikum Augsburg
Augsburg, Bavaria, Germany
No email / No phone
Status: Recruiting
Asklepios Klinik Altona
Hamburg, Free and Hanseatic City of Hamburg, Germany
No email / No phone
Status: Recruiting
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
No email / No phone
Status: Recruiting
Humanitas San Pio X
Milan, Italy
No email / No phone
Status: Recruiting
IRCCS - lstituto Nazionale Tumori - Fondazione G. Pascale
Naples, 80131, Italy
No email / No phone
Status: Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
No email / No phone
Status: Recruiting
Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori Regina Elena
Rome, Lazio, Italy
No email / No phone
Status: Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy
No email / No phone
Status: Recruiting
Fondazione IRCCS Istituto Nazionale Dei Tumori
Milan, Lombardy, Italy
No email / No phone
Status: Recruiting
Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
No email / No phone
Status: Recruiting
Istituto Europeo Di Oncologia
Milan, Lombardy, Italy
No email / No phone
Status: Recruiting
Fondazione del Piemonte per l'Oncologia (IRCCS)
Candiolo, Torino, Italy
No email / No phone
Status: Recruiting
National Cancer Center of Singapore
Singapore, 168582, Singapore
No email / No phone
Status: Recruiting
National University Hospital
Kent Ridge, Singapore
No email / No phone
Status: Recruiting
Asan Medical Center
Seoul, South Korea
No email / No phone
Status: Recruiting
National Cancer Center
Seoul, South Korea
No email / No phone
Status: Recruiting
Samsung Medical Center
Seoul, South Korea
No email / No phone
Status: Recruiting
Seoul University Hospital
Seoul, South Korea
No email / No phone
Status: Recruiting
Severance Hospital Yonsei University
Seoul, South Korea
No email / No phone
Status: Recruiting
Hospital Clinico Universitario de Valencia
Valencia, Spain
No email / No phone
Status: Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
No email / No phone
Status: Recruiting
Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON
Barcelona, Spain
No email / No phone
Status: Recruiting
NEXT Oncology-Hospital Quironsalud Barcelona
Barcelona, Spain
No email / No phone
Status: Recruiting
START Rioja
Rioja, Spain
No email / No phone
Status: Recruiting
START MADRID_Hospital Universitario Fundacion Jimenez Diaz
Madrid, Madrid, Spain
No email / No phone
Status: Recruiting
START MADRID_Hospital Universitario HM Sanchinarro - CIOCC
Madrid, Madrid, Spain
No email / No phone
Status: Recruiting
Sarah Cannon Research Institute UK
London, Middlesex, United Kingdom
No email / No phone
Status: Recruiting
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, United Kingdom
No email / No phone
Status: Recruiting
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, 90024, United States
No email / No phone
Status: Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
No email / No phone
Status: Recruiting
University of California Irvine Chao Family Comprehensive Cancer Center
Irvine, California, 92868, United States
No email / No phone
Status: Recruiting
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
No email / No phone
Status: Recruiting
Yale Cancer Center
New Haven, Connecticut, 06519, United States
No email / No phone
Status: Recruiting
Medical Oncology Hematology Consultants
Newark, Delaware, 19713, United States
No email / No phone
Status: Recruiting
Florida Cancer Specialists South
Port Charlotte, Florida, 33980, United States
No email / No phone
Status: Recruiting
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
No email / No phone
Status: Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
No email / No phone
Status: Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
No email / No phone
Status: Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
No email / No phone
Status: Recruiting
Memorial Sloan Kettering
New York, New York, 10065, United States
No email / No phone
Status: Recruiting
Duke University
Durham, North Carolina, 27705, United States
No email / No phone
Status: Recruiting
The Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
No email / No phone
Status: Recruiting
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
No email / No phone
Status: Recruiting
Oregon Health & Science University (OHSU)
Portland, Oregon, 97210, United States
No email / No phone
Status: Recruiting
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
No email / No phone
Status: Recruiting
WellSpan York Cancer Center
York, Pennsylvania, 17403, United States
No email / No phone
Status: Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
No email / No phone
Status: Recruiting
New Experimental Therapeutics - NEXT Oncology
Austin, Texas, 78705, United States
No email / No phone
Status: Recruiting
New Experimental Therapeutics of San Antonio - NEXT Oncology
San Antonio, Texas, 78229, United States
No email / No phone
Status: Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
No email / No phone
Status: Recruiting
UT Southwest Simmons Cancer Center
Dallas, Texas, 75390, United States
No email / No phone
Status: Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
No email / No phone
Status: Recruiting
University of Washington, Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
No email / No phone
Status: Recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705, United States
No email / No phone
Status: Recruiting
University of San Diego Moores Cancer Center
La Jolla, California, 92093, United States
No email / No phone
Status: Not yet recruiting
Advent Health
Orlando, Florida, 32803, United States
No email / No phone
Status: Not yet recruiting
Columbia University
New York, New York, 10032, United States
No email / No phone
Status: Not yet recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
No email / No phone
Status: Not yet recruiting
UTSW - Moody Outpatient Center - Parkland Health
Dallas, Texas, 75235, United States
No email / No phone
Status: Not yet recruiting
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
No email / No phone
Status: Withdrawn
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
No email / No phone
Status: TERMINATED
