An Open Label Study Evaluating the Efficacy and Safety of Etrumadenant (AB928) Based Treatment Combinations in Participants With Metastatic Colorectal Cancer.

Completed · Phase 1/Phase 2

Conditions studied: Metastatic Colorectal Cancer

In brief

This randomized phase 1b/2 open-label study will evaluate the antitumour activity and safety of etrumadenant (AB928) treatment combinations in participants with metastatic colorectal cancer.

Key facts

Study ID

NCT04660812

Run by

Arcus Biosciences, Inc.

People needed

227

Starts

2021-05-10

Expected to finish

2025-09-05

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female participants ≥ 18 years of age
• 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.
• Inclusion Criteria for Cohort A:
• 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
• Inclusion Criteria for Cohort B:
• 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

You may not qualify if…

• Previous anticancer treatment within 4 weeks prior to initiation of study treatment
• 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
• Exclusion Criteria for Cohorts A and B:
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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