Spots Global Cancer Trial Database for A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
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Trial Identification
Brief Title: A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Official Title: A Randomized, Open-Label, Phase 2 Study of Botensilimab (AGEN1181) as Monotherapy and in Combination With Balstilimab (AGEN2034) or Investigator's Choice Standard of Care (Regorafenib or Trifluridine and Tipiracil) for the Treatment of Refractory Metastatic Colorectal Cancer
Study ID: NCT05608044
Conditions
Study Description
Brief Summary: This is an open-label, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab or standard-of-care treatments in participants with refractory metastatic colorectal cancer.
Detailed Description: This study will enroll adult participants with a confirmed diagnosis of unresectable metastatic colorectal adenocarcinoma (CRC) who have had prior chemotherapy for metastatic or recurrent CRC. This study will consist of 5 cohorts. In the first and second cohorts, participants will receive 1 of 2 different doses of botensilimab intravenously (IV) and balstilimab IV. In the third and fourth cohorts, participants will receive 1 of 2 different doses of botensilimab. In the fifth cohort, participants will receive standard of care consisting of the investigator's choice of regorafenib or trifluridine and tipiracil.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
HonorHealth Research Institute, Scottsdale, Arizona, United States
City of Hope National Medical Center, Duarte, California, United States
Keck School of Medicine of the University of Southern California, Los Angeles, California, United States
Rocky Mountain Cancer Center - Aurora, Aurora, Colorado, United States
University of Colorado, Denver, Colorado, United States
Medical Oncology Hematology Consultants, Newark, Delaware, United States
Florida Cancer Specialists and Research Institute - Lake Mary, Lake Mary, Florida, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Atlantic Health System - Morristown Medical Center, Morristown, New Jersey, United States
Weill Cornell Medical College, New York, New York, United States
Mount Sinai Hospital - New York, New York, New York, United States
Memorial Sloan Kettering, New York, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
Earle A. Chiles Research Institute - Robert W. Franz Cancer Center - Providence Cancer Institute, Portland, Oregon, United States
Oregon Health & Science University (OHSU), Portland, Oregon, United States
Lifespan Clinical Research Center/Cancer Institute (Providence Rhode Island), East Providence, Rhode Island, United States
Tennessee Oncology Nashville (Sarah Cannon), Nashville, Tennessee, United States
Vanderbilt University School of Medicine, Nashville, Tennessee, United States
Texas Oncology - Austin Midtown, Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
MDACC, Houston, Texas, United States
Virginia Cancer Specialists/NEXT Virginia, Fairfax, Virginia, United States
Swedish Cancer Institute, Seattle, Washington, United States
Northwest Cancer Center Specialists - Vancouver Cancer Center - Compass Oncology Vancouver, Vancouver, Washington, United States
Antwerp University Hospital (UZA), Edegem, , Belgium
Universitair Ziekenhuis Leuven, Leuven, , Belgium
Centro de Pesquisas Clinicas da Fundação Doutor Amaral Carvalho, Jaú, São Paulo, Brazil
Hospital Sirio Libanes Brasilia, Brasília, , Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia, Ijuí, , Brazil
Catarina Pesquisa Clinica, Itajaí, , Brazil
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa, Porto Alegre, , Brazil
Instituto Sul Mineiro de Oncologia - ONCOMINAS, Pouso Alegre, , Brazil
Instituto Americas, Rio de Janeiro, , Brazil
Hospital A.C. Camargo Cancer Center, São Paulo, , Brazil
Centro Paulista de Oncologia, São Paulo, , Brazil
Service d'Oncologie Medicale - CHRU Besancon, Besançon, , France
Centre Georges Francois Leclerc, Dijon, , France
Centre Leon Berard, Lyon, , France
Institut Paoli-Calmettes, Marseille, , France
Hôpital Saint Antoine/AP-HP Hopital Saint Antoine (Pierre and Marie Curie University), Paris, , France
CHU Poitiers - Pole Regional de Cancerologie de Poitiers (PRC), Poitiers, , France
Unversite Paris-Saclay Gustave Roussy Cancer Center Campus Paris, Villejuif, , France
IRCCS Azienda Ospedaliera Universitaria San Martino IST, Genova, , Italy
Fondazione IRCCS Instituto Nazionale dei Tumori, Milano, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Istituto Oncologico Veneto, Padova, , Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento di Santa Chiara, Pisa, , Italy
RSBIHC "Altai Region Oncology Dispansery", Barnaul, , Russian Federation
Limited Liability Company "EVIMED", Chelyabinsk, , Russian Federation
SBHI "Clinical Oncological Dispensary #1", Krasnodar, , Russian Federation
"Kursk Oncological Research and Clinical Center named after G. E. Ostroverkhova", Kursk, , Russian Federation
SBIH of the City of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Department of Health of the City of Moscow", Moscow, , Russian Federation
FSBI N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation, Moscow, , Russian Federation
FSAEI of HE I.M. Sechenov First Moscow State Medical University of the MoH of the RF, Moscow, , Russian Federation
Branch office of " Hadassah Medical Ltd", Moscow, , Russian Federation
Closed Joint Stock Company Medical Center "AVICENNA", Novosibirsk, , Russian Federation
BHI of the Omsk region "Clinical oncological dispensary", Omsk, , Russian Federation
SAHI "Orenburg Regional Clinical Oncological Dispensary", Orenburg, , Russian Federation
"Clinical Hospital "RZD-Medicine" of Saint Petersburg", Saint Petersburg, , Russian Federation
Federal State Budgetary Institution "National Medical Research Center of Oncology named after N.N. Petrov" оf the Ministry of Health of the Russian Federation, Saint Petersburg, , Russian Federation
State Budgetary Healthcare Institution "Saint-Petersburg clinical scientific and practical center for specialised types of medical care (oncological)", Saint Petersburg, , Russian Federation
Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology), Saint Petersburg, , Russian Federation
Siberian State Medical University, Tomsk, , Russian Federation
Vall d'Hebron Institute of Oncology (VHIO), Barcelona, , Spain
Clínica Universidad de Navarra - Sede Madrid, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Clínica Universidad de Navarra - Sede Pamplona, Pamplona, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Contact Details
Name: Medical Director
Affiliation: Agenus Inc.
Role: STUDY_DIRECTOR
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