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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Arcus Biosciences, Inc.
Study ID
NCT04660812
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

First listed
Dec 9, 2020
Start date
May 10, 2021
Status verified
May 2025
Primary completion
Sep 5, 2025
Completion
Sep 5, 2025

Study Design

Enrollment
227 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Etrumadenant + Zimberelimab + mFOLFOX-6 +/- Bevacizumab
    Participants will receive oral etrumadenant in combination with zimberelimab +mFOLFOX-6 +/-bevacizumab by IV infusion.
  • Active Comparator: mFOLFOX-6 +/- Bevacizumab
    Participants will receive mFOLFOX-6 +/- bevacizumab by IV infusion.
  • Active Comparator: Regorafenib
    Participants will receive oral regorafenib
  • Experimental: AB680 + Etrumadenant + Zimberelimab
    Participants will receive oral etrumadenant in combination with AB680 + zimberelimab by IV infusion.

Primary Outcome Measure

Cohort A and B - Progression-free Survival (PFS) [ Time Frame: From randomization until death from any cause (up to approximately 3-7 years) ]

Locations (17)

FacilityCityStateZIPSite coordinators
Arizona Clinical Research Center IncTucsonArizona85715-
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
UCLA Hematology OncologySanta MonicaCalifornia90404-
Yale Cancer CenterNew HavenConnecticut06510-
Sibley Memorial HospitalWashington D.C.District of Columbia20016-2633-
Winship Cancer Institute at Emory UniversityAtlantaGeorgia30322-
Ochsner Medical Center (OMC)New OrleansLouisiana70121-
American Oncology Partners of Maryland PABethesdaMaryland20817-
Washington University School of MedicineSt LouisMissouri63110-
Comprehensive Cancer Centers Of NevadaLas VegasNevada89169-
New York-Presbyterian Hospital-Columbia University Medical CenterNew YorkNew York10032-
NYU Langone Medical Center - NYU Medical Oncology AssociatesNew YorkNew York10016-
Prisma Health-UpstateGreenvilleSouth Carolina29605-
Sarah Cannon Research InstituteNashvilleTennessee37232-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37203-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
University of Wisconsin School of MedicineMadisonWisconsin53792-

Find similar trials in Tucson, AZ

By research site
Arizona Clinical Research Center Inc· Tucson, AZCity of Hope Comprehensive Cancer Center· Duarte, CAUCLA Hematology Oncology· Santa Monica, CAYale Cancer Center· New Haven, CTSibley Memorial Hospital· Washington D.C., DCWinship Cancer Institute at Emory University· Atlanta, GA

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