A Phase 1/2 interventional study of AB680 and Etrumadenant in Metastatic Colorectal Cancer, sponsored by Arcus Biosciences, Inc.. Completed at 44 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-20.
Sponsored by Arcus Biosciences, Inc. · Phase 1/2, Interventional, and Treatment
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.
This is a multicenter, open-label Phase 1b/2 study in participants with metastatic colorectal cancer that will assess the antitumour activity and safety of etrumadenant.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 227 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Arcus Biosciences, Inc. is the lead sponsor of 32 studies on the registry; 4 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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
Exclusion Criteria:
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
Participants will receive oral etrumadenant in combination with zimberelimab +mFOLFOX-6 +/-bevacizumab by IV infusion.
Drug: Etrumadenant · Drug: Zimberelimab · Drug: Bevacizumab · Drug: m-FOLFOX-6 regimen
Participants will receive mFOLFOX-6 +/- bevacizumab by IV infusion.
Drug: Bevacizumab · Drug: m-FOLFOX-6 regimen
Participants will receive oral regorafenib
Drug: Regorafenib
Participants will receive oral etrumadenant in combination with AB680 + zimberelimab by IV infusion.
Drug: AB680 · Drug: Etrumadenant · Drug: Zimberelimab
AB680 is a cluster of differentiated CD73 Inhibitor
Etrumadenant is a dual adenosine receptor (A2aR and A2bR) antagonist
Also known as: AB928
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Also known as: AB122
Bevacizumab is administered as part of standard chemotherapy regimen
mFOLFOX-6 regimen is administered as part of standard chemotherapy regimen
Regorafenib is administered as part of standard chemotherapy regimen
Cohort A and B - Progression-free Survival (PFS)
PFS according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by the Investigator
Time frame: From randomization until death from any cause (up to approximately 3-7 years)
Cohort C - Objective Response Rate (ORR)
ORR according to RECIST v1.1, as assessed by the Investigator
Time frame: From randomization until death from any cause (up to approximately 3-7 years)
Number of Participants With Treatment-emergent Adverse Events
Time frame: Up to approximately 10 Months
Cohorts A and B - Objective Response Rate (ORR)
ORR according to RECIST v1.1 as assessed by the Investigator
Time frame: From randomization until death from any cause (up to approximately 3-7 years)
Cohorts A, B, and C- Duration of Disease Response (DoR)
DoR according to RECIST v1.1, as assessed by the Investigator
Time frame: From randomization until death from any cause (up to approximately 3-7 years)
Cohorts A, B, and C- Disease Control Rate (DCR)
DCR according to RECIST v1.1, as assessed by the Investigator
Time frame: From randomization until death from any cause (up to approximately 3-7 years)
Cohorts A and B - Overall Survival (OS)
OS according to RECIST v1.1, as assessed by the Investigator
Time frame: From randomization until death from any cause (up to approximately 3-7 years)
Observed Maximum Concentration (Cmax) of Etrumadenant and its Metabolites
Cycle 1 Day 1 and Cycle 2 Day 1
Time frame: From randomization until death from any cause (up to approximately 10 months)
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours [AUC(0-24)] of Etrumadenant and its Metabolites
Time frame: Up to 24 hours following Day 1 Cycle 1 and Cycle 2 (each cycle is 28 days)
Trough Concentrations of Etrumadenant and its Metabolites
Time frame: Multiple timepoints up to approximately 16 months
Cmax End of Infusion (EOI) of AB680
Time frame: At the end of infusion on Day 1 Cycle 1 and Cycle 2 (each cycle is 28 days)
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 336 Hours [AUC(0-336)] of AB680
Time frame: Up to 336 hours following Day 1 Cycle and Cycle 2 (each cycle is 28 days)]
Trough Concentrations of AB680
Time frame: Multiple timepoints up to approximately 16 months
Cmax EOI of Zimberelimab
Time frame: Multiple timepoints up to approximately 16 months
AUV(0-336) of Zimberelimab
Time frame: Cycle 1 Day 1 up to 336 hours
Trough Concentrations of Zimberelimab
Time frame: Multiple timepoints up to approximately 16 months
Number of Participants With Anti-Drug Antibodies to the Biologic Component(s) of Combination Therapy
Time frame: Up to approximately 10 months
Plan to share: Yes — Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Arcus Biosciences, Inc.