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Adenosine Receptor Antagonist

Adenosine Receptor Antagonist Combination Therapy for Prostate Cancer (ARC-6 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
Metastatic castrate-resistant prostate cancer while on anti-androgen treatment with castrate levels of testosterone (≤1.7 nanomoles per liter [nmol/L] or 50 nanograms per deciliter [ng/dL])
Male participants; age ≥ 18 years
Must not have
All other Participants: Prior treatment with docetaxel, cabazitaxel, topoisomerase 1 inhibitors, or other taxane chemotherapy, Active or history of autoimmune disease or immune deficiency, History of severe allergic reactions to antibody therapy, Concomitant use of a medication prohibited by the protocol (including certain transporter substrates as well as known strong CYP3A4 inducers and CYP3A4 inhibitors) within 4 weeks prior to and throughout study treatment
Prior treatment with immune checkpoint blockade therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years)
Awards & highlights
No Placebo-Only Group

Summary

This study is evaluating whether a drug may help treat prostate cancer.

Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread, who haven't had certain recent treatments or infections, can join. They need a life expectancy of at least 3 months, no severe heart issues or lung conditions like fibrosis, and must not have brain metastases or another cancer within the last two years.
What is being tested?
The trial is testing combinations of drugs including Docetaxel, SG (an unspecified agent), Etrumadenant, Zimberelimab, Quemliclustat, and Enzalutamide for their effectiveness in treating advanced prostate cancer. It's an early-phase trial to see how well these drugs work together.
What are the potential side effects?
Possible side effects may include reactions related to the immune system such as fatigue and flu-like symptoms; digestive issues; skin reactions; potential impact on liver function; blood-related problems like anemia; and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer has spread and does not respond to hormone therapy.
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I am a man aged 18 or older.
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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 progressed after treatment with abiraterone.
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My cancer progressed after treatment to lower male hormones.
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My cancer progressed after hormone therapy and I've had up to 2 taxane chemotherapies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with immune checkpoint inhibitors before.
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I cannot swallow pills.
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I have been treated with medication targeting the adenosine pathway before.
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I haven't had cancer treatment, including trials or radiation, in the last 2-4 weeks.
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My heart is healthy without major issues.
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I have had lung fibrosis, pneumonia, or pneumonitis before.
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My cancer has spread to my brain or into the fluid around my brain and spinal cord.
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I have had a previous transplant of stem cells or an organ.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study enrollment until disease progression or loss of clinical benefit (approximately 3-5 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
Objective Response Rate (ORR) in Stage 1 and 2
Secondary study objectives
Percentage of Participants with Disease Control Rate in Stage 1 and 2
Percentage of participants with Radiographic Response in Stage 1 and 2
Percentage of participants with a PSA response in Stage 1 and 2

Awards & Highlights

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

Trial Design

10Treatment groups
Experimental Treatment
Active Control
Group I: Stage 2: Etrumadenant + zimberelimab + quemliclustatExperimental Treatment3 Interventions
Participants will receive oral etrumadenant in combination with IV zimberelimab and IV quemliclustat
Group II: Stage 2: Etrumadenant + quemliclustatExperimental Treatment2 Interventions
Participants will receive oral etrumadenant in combination with IV quemliclustat
Group III: Stage 1: Etrumadenant + zimberelimab PK Sub-StudyExperimental Treatment2 Interventions
Participants will receive oral etrumadenant in combination with IV zimberelimab
Group IV: Stage 1 and 2: Etrumadenant + zimberelimab + enzalutamideExperimental Treatment3 Interventions
Participants will receive oral etrumadenant in combination with intravenous (IV) zimberelimab and standard oral enzalutamide
Group V: Stage 1 and 2: Etrumadenant + zimberelimab + docetaxelExperimental Treatment3 Interventions
Participants will receive oral etrumadenant in combination with IV zimberelimab and standard IV docetaxel
Group VI: Stage 1 and 2: Etrumadenant + zimberelimabExperimental Treatment2 Interventions
Oral etrumadenant in combination IV zimberelimab
Group VII: Stage 1 and 2: Etrumadenant + Zimberelimab + SGExperimental Treatment3 Interventions
Participants will receive oral etrumadenant in combination with IV zimberelimab and SG.
Group VIII: Stage 1 and 2: Etrumadenant + SGExperimental Treatment2 Interventions
Participants will receive oral etrumadenant in combination with IV SG.
Group IX: Stage 2: docetaxelActive Control1 Intervention
Participants will receive standard dose of IV docetaxel
Group X: Stage 2: enzalutamideActive Control1 Intervention
Participants will receive standard oral enzalutamide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~6550
SG
2017
Completed Phase 2
~540
Etrumadenant
2018
Completed Phase 2
~300
Zimberelimab
2020
Completed Phase 2
~230
Quemliclustat
2020
Completed Phase 2
~180
Enzalutamide
2014
Completed Phase 4
~3820

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for prostate cancer include androgen deprivation therapy (ADT), androgen receptor inhibitors, chemotherapy, and novel agents like adenosine receptor antagonists. ADT reduces androgen levels to slow cancer growth, while androgen receptor inhibitors block the cancer cells' ability to use androgens. Chemotherapy, such as docetaxel, targets rapidly dividing cancer cells. Etrumadenant (AB928) is an adenosine A2a and A2b receptor antagonist that disrupts the tumor microenvironment by inhibiting adenosine signaling, which can suppress immune responses against the tumor. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the cancer's characteristics and progression.
A Feasibility Study of the Therapeutic Response and Durability of Short-term Androgen-targeted Therapy in Early Prostate Cancer Managed with Surveillance: The Therapeutics in Active Prostate Surveillance (TAPS01) Study.Treating Prostate Cancer by Antibody-Drug Conjugates.A phase II trial of docetaxel and erlotinib as first-line therapy for elderly patients with androgen-independent prostate cancer.

Find a Location

Who is running the clinical trial?

Arcus Biosciences, Inc.Lead Sponsor
42 Previous Clinical Trials
6,913 Total Patients Enrolled
1 Trials studying Prostate Cancer
16 Patients Enrolled for Prostate Cancer
Gilead SciencesIndustry Sponsor
1,129 Previous Clinical Trials
867,339 Total Patients Enrolled
3 Trials studying Prostate Cancer
856 Patients Enrolled for Prostate Cancer
Medical DirectorStudy DirectorArcus Biosciences
2,868 Previous Clinical Trials
8,082,457 Total Patients Enrolled
14 Trials studying Prostate Cancer
3,648 Patients Enrolled for Prostate Cancer

Media Library

Etrumadenant (Adenosine Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04381832 — Phase 1 & 2
Prostate Cancer Research Study Groups: Stage 1 and 2: Etrumadenant + zimberelimab + enzalutamide, Stage 1 and 2: Etrumadenant + zimberelimab, Stage 1: Etrumadenant + zimberelimab PK Sub-Study, Stage 1 and 2: Etrumadenant + SG, Stage 2: Etrumadenant + quemliclustat, Stage 1 and 2: Etrumadenant + zimberelimab + docetaxel, Stage 2: docetaxel, Stage 2: enzalutamide, Stage 2: Etrumadenant + zimberelimab + quemliclustat, Stage 1 and 2: Etrumadenant + Zimberelimab + SG
Prostate Cancer Clinical Trial 2023: Etrumadenant Highlights & Side Effects. Trial Name: NCT04381832 — Phase 1 & 2
Etrumadenant (Adenosine Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04381832 — Phase 1 & 2
~33 spots leftby Oct 2025