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

COMPLETEDPHASE1/PHASE2

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

NCT04660812•Arcus Biosciences, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•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

•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
+13 more criteria

Locations (44)

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

Key Dates

Start Date

May 10, 2021

Primary Completion Date

September 5, 2025

Completion Date

September 5, 2025

Last Updated

October 20, 2025

Enrollment

227

ACTUAL participants

Conditions

Metastatic Colorectal Cancer

Interventions

AB680

DRUG

Etrumadenant

DRUG

Zimberelimab

DRUG

Bevacizumab

DRUG

m-FOLFOX-6 regimen

DRUG

Regorafenib

DRUG

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NCT04657068

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RECRUITINGPHASE1

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Solid Tumor, AdultMetastatic Breast Cancer+9 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

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