An Open Label Study Evaluating the Efficacy and Safety of Etrumadenant (AB928) Based Treatment Combinations in Participants With Metastatic Colorectal Cancer.
NCT ID: NCT04660812
Last Updated: 2025-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
227 participants
INTERVENTIONAL
2021-05-10
2025-09-05
Brief Summary
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Detailed Description
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Approximately 250 participants will be enrolled to 1 of 3 cohorts:
Cohort A) etrumadenant + zimberelimab +mFOLFOX-6 +/-bevacizumab vs mFOLFOX-6 +/-bevacizumab
Cohort B) etrumadenant + zimberelimab +mFOLFOX-6 +/-bevacizumab vs regorafenib
Cohort C) chemotherapy-free combinations of etrumadenant + zimberelimab + other agents
The primary objective of this clinical study is to evaluate the safety of etrumadenant-based combination therapy in participants with metastatic colorectal cancer.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Etrumadenant + Zimberelimab + mFOLFOX-6 +/- Bevacizumab
Participants will receive oral etrumadenant in combination with zimberelimab +mFOLFOX-6 +/-bevacizumab by IV infusion.
Etrumadenant
Etrumadenant is a dual adenosine receptor (A2aR and A2bR) antagonist
Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Bevacizumab
Bevacizumab is administered as part of standard chemotherapy regimen
m-FOLFOX-6 regimen
mFOLFOX-6 regimen is administered as part of standard chemotherapy regimen
mFOLFOX-6 +/- Bevacizumab
Participants will receive mFOLFOX-6 +/- bevacizumab by IV infusion.
Bevacizumab
Bevacizumab is administered as part of standard chemotherapy regimen
m-FOLFOX-6 regimen
mFOLFOX-6 regimen is administered as part of standard chemotherapy regimen
Regorafenib
Participants will receive oral regorafenib
Regorafenib
Regorafenib is administered as part of standard chemotherapy regimen
AB680 + Etrumadenant + Zimberelimab
Participants will receive oral etrumadenant in combination with AB680 + zimberelimab by IV infusion.
AB680
AB680 is a cluster of differentiated CD73 Inhibitor
Etrumadenant
Etrumadenant is a dual adenosine receptor (A2aR and A2bR) antagonist
Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Interventions
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AB680
AB680 is a cluster of differentiated CD73 Inhibitor
Etrumadenant
Etrumadenant is a dual adenosine receptor (A2aR and A2bR) antagonist
Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Bevacizumab
Bevacizumab is administered as part of standard chemotherapy regimen
m-FOLFOX-6 regimen
mFOLFOX-6 regimen is administered as part of standard chemotherapy regimen
Regorafenib
Regorafenib is administered as part of standard chemotherapy regimen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed metastatic colorectal adenocarcinoma
* Must have at least 1 measurable lesion per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy at least 3 months
* Adequate hematologic and end-organ function
* Negative HIV, Hep B and Hep C antibody testing
* Agreement to remain abstinent or use contraceptive measures with female partners of reproductive potential, and agreement to refrain from donating sperm, for 30 days after the last dose of etrumadenant, 90 days after the last dose of zim, 180 days after mFOLFOX-6 and 180 days after bev, whichever is longer.
* Disease progression following not more than one prior line of treatment for mCRC that consisted of oxaliplatin or irinotecan containing chemotherapy in combination with a biologic agent
* Disease progression during or following not more than two separate lines of treatment for mCRC that consisted of oxaliplatin, and irinotecan containing chemotherapy in combination with a biologic agent
Exclusion Criteria
* Prior allogeneic stem cell or solid organ transplant
* Treatment with systemic immunostimulatory agents within 4 weeks prior to initiation of study treatment
* Use of any live vaccines against infectious diseases within 28 days of first dose.
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Current treatment with anti-viral therapy for HBV
* Structurally unstable bone lesions suggesting impending fracture
* History or leptomeningeal disease
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
* History of malignancy other than colorectal cancer within 2 years prior to screening, except for malignancies such as non-melanoma skin carcinoma or ductal carcinoma in situ
* Active tuberculosis
* Treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiating study treatment
* Severe infection within 4 weeks (28 days) prior to initiation of study treatment
* Significant cardiovascular disease, unstable or new onset of angina within 3 months prior to initiation of treatment, or myocardial infarction within 6 months prior to study treatment or unstable arrhythmia
* Major surgical procedures, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for major surgical procedure during the study
* Known allergy or hypersensitivity to any of the study drugs or their excipients
* Inability to swallow medications
* Malabsorption condition that would alter the absorption of orally administered medications
* Evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation)
* Prior treatment with an agent targeting the adenosine pathway
* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain Barré syndrome, or multiple sclerosis
* Prior treatment with immune checkpoint blockade therapies including anti-cytotoxic T lymphocyte-associated protein-4, anti PD-1, and anti-PD-L1 therapeutic antibodies
* Mutation in the BRAF oncogene. Patients with unknown BRAF status will be required to undergo testing at a local laboratory and provide results at screening
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Arcus Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Arcus Biosciences
Locations
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Arizona Clinical Research Center Inc
Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
UCLA Hematology Oncology
Santa Monica, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States
Ochsner Medical Center (OMC)
New Orleans, Louisiana, United States
American Oncology Partners of Maryland PA
Bethesda, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
Comprehensive Cancer Centers Of Nevada
Las Vegas, Nevada, United States
NYU Langone Medical Center - NYU Medical Oncology Associates
New York, New York, United States
New York-Presbyterian Hospital-Columbia University Medical Center
New York, New York, United States
Prisma Health-Upstate
Greenville, South Carolina, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin School of Medicine
Madison, Wisconsin, United States
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, , France
Centre Georges Francois Leclerc
Dijon, , France
Hopital Hotel Dieu
Nantes, , France
Hopital Saint Antoine
Paris, , France
Groupe Hospitalier Pitie-Salpetriere-Centre De Recherche et de Medecine de l'Obesite
Paris, , France
CHU la Miletrie
Poitiers, , France
IRCCS - Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Castellana Grotte, , Italy
Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica
Florence, , Italy
Azienda Ospedaliera Niguarda Ca' Granda
Milan, , Italy
Instituto Europeo di Oncologia
Milan, , Italy
Istituto Clinico Humanitas IRCCS
Rozzano, , Italy
Universita di Siena - Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
Siena, , Italy
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Seoul National University Bundang Hospital
Seoul, , South Korea
Seoul National University Hospital (SNUH)
Seoul, , South Korea
Severance Hospital | Yonsei University Health System
Seoul, , South Korea
Asan Medical Center | University of Ulsan College of Medicine
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Kyungpook National University Chilgok Hospital
Seoul, , South Korea
Hospital Universitario La Paz
Madrid, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Complejo Hospitalario de Orense
Ourense, , Spain
Clinica Universidad Navarra-Sede Madrid
Pamplona, , Spain
Corporacio Sanitaria Parc Tauli
Sabadell, , Spain
Belfast City Hospital
Belfast, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Countries
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Related Links
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ARC-9 - Public website
Other Identifiers
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2020-005386-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ARC-9
Identifier Type: -
Identifier Source: org_study_id
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