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Small Molecule

Etrumadenant-Based Combinations for Colorectal Cancer (ARC-9 Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Arcus Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically confirmed metastatic colorectal adenocarcinoma
Must not have
Active tuberculosis
Evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until death from any cause (up to approximately 3-7 years)
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of a new drug, etrumadenant, on participants with metastatic colorectal cancer.

Who is the study for?
Adults with metastatic colorectal cancer who've had no more than two prior treatments can join this trial. They must have a measurable tumor, be HIV and hepatitis negative, have good organ function and performance status (able to carry out daily activities), and agree to contraception. Exclusions include certain heart conditions, active infections, recent vaccines or surgeries, other cancers within 2 years (except some skin cancers), CNS metastases, autoimmune diseases, or previous treatment with similar drugs.
What is being tested?
The study is testing combinations of Etrumadenant with other cancer drugs like Zimberelimab and Bevacizumab in patients whose disease has progressed after treatment. It's an open-label trial where everyone knows what treatment they're getting; it aims to see how well these drug combos work against advanced colorectal cancer.
What are the potential side effects?
Possible side effects may include allergic reactions to the medication components, increased risk of infection due to immune system effects from Zimberelimab or Etrumadenant, bleeding risks associated with Bevacizumab use on top of general chemotherapy side effects such as fatigue, digestive issues and blood cell count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is a type of colorectal cancer that has spread.
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My colorectal cancer worsened after one treatment including oxaliplatin or irinotecan with a biologic.
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My colorectal cancer worsened after up to two treatments including oxaliplatin, irinotecan, and a biologic.
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My colorectal cancer worsened after one treatment including oxaliplatin or irinotecan and a biologic.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have active tuberculosis.
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I have a bleeding disorder that increases my risk of bleeding.
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I have never received immune checkpoint inhibitors for my condition.
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I have a history of lung scarring or inflammation not caused by infections.
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I have had cancer spread to the lining of my brain or spinal cord.
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I have had a stem cell or organ transplant in the past.
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I have not had any cancer other than colorectal cancer in the last 2 years, except for non-dangerous skin cancer or a specific breast cancer.
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I have weak bones at risk of breaking.
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I have been treated with drugs targeting the adenosine pathway before.
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I haven't had major surgery in the last 4 weeks and don't expect to need any during the study.
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I am currently on medication for hepatitis B.
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I cannot swallow pills.
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I have brain metastases that are untreated or getting worse.
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I have a condition that affects how my body absorbs pills.
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I have or had an autoimmune disease or immune deficiency.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until death from any cause (up to approximately 3-7 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until death from any cause (up to approximately 3-7 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cohort A and B - Progression-free Survival (PFS)
Cohort C - Objective Response Rate (ORR)
Secondary study objectives
Cohorts A and B - Objective Response Rate (ORR)
Cohorts A and B - Overall Survival (OS)
Cohorts A, B, and C- Disease Control Rate (DCR)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Etrumadenant + Zimberelimab + mFOLFOX-6 +/- BevacizumabExperimental Treatment4 Interventions
Participants will receive oral etrumadenant in combination with zimberelimab +mFOLFOX-6 +/-bevacizumab by IV infusion.
Group II: AB680 + Etrumadent+ ZimberelimabExperimental Treatment3 Interventions
Participants will receive oral etrmadenant in combination with AB680 + zimberelimab by IV infusion.
Group III: mFOLFOX-6 +/- BevacizumabActive Control2 Interventions
Participants will receive mFOLFOX-6 +/- bevacizumab by IV infusion.
Group IV: RegorafenibActive Control1 Intervention
Participants will receive oral regorafenib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etrumadenant
2018
Completed Phase 2
~300
Bevacizumab
2013
Completed Phase 4
~5540
Zimberelimab
2020
Completed Phase 2
~230
AB680
2018
Completed Phase 1
~100

Find a Location

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor
1,135 Previous Clinical Trials
867,809 Total Patients Enrolled
Arcus Biosciences, Inc.Lead Sponsor
42 Previous Clinical Trials
6,865 Total Patients Enrolled
Medical DirectorStudy DirectorArcus Biosciences
2,900 Previous Clinical Trials
8,090,207 Total Patients Enrolled

Media Library

AB680 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04660812 — Phase 1 & 2
Colorectal Cancer Research Study Groups: mFOLFOX-6 +/- Bevacizumab, Regorafenib, AB680 + Etrumadent+ Zimberelimab, Etrumadenant + Zimberelimab + mFOLFOX-6 +/- Bevacizumab
Colorectal Cancer Clinical Trial 2023: AB680 Highlights & Side Effects. Trial Name: NCT04660812 — Phase 1 & 2
AB680 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04660812 — Phase 1 & 2
~28 spots leftby Jul 2025
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