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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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