NCT04660812

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

A Phase 1b/2, Open-Label, Randomized Platform Study Evaluating The Efficacy and Safety of AB928 Based Treatment Combinations in Patients With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: Arcus Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	AB680	AB680 is a cluster of differentiated CD73 Inhibitor
DRUG	Etrumadenant	Etrumadenant is a dual adenosine receptor (A2aR and A2bR) antagonist
DRUG	Zimberelimab	Zimberelimab is a fully human anti-PD-1 monoclonal antibody
DRUG	Bevacizumab	Bevacizumab is administered as part of standard chemotherapy regimen
DRUG	m-FOLFOX-6 regimen	mFOLFOX-6 regimen is administered as part of standard chemotherapy regimen
DRUG	Regorafenib	Regorafenib is administered as part of standard chemotherapy regimen

Timeline

• Start date: 2021-05-10
• Primary completion: 2025-09-05
• Completion: 2025-09-05
• First posted: 2020-12-09
• Last updated: 2025-10-20

Locations

44 sites across 6 countries: United States, France, Italy, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study