What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as androgen receptor inhibitors (e.g., enzalutamide, abiraterone), chemotherapy agents (e.g., docetaxel, cabazitaxel), and radioligand therapies (e.g., Lu-177-PSMA), are associated with a range of side effects. Androgen receptor inhibitors often cause fatigue, hypertension, and gastrointestinal issues like nausea and anorexia. Chemotherapy agents can lead to myelosuppression, anemia, fatigue, and gastrointestinal disturbances. Radioligand therapies frequently result in myelosuppression, nephrotoxicity, and salivary gland toxicity, including dry mouth and pain. These side effects are important considerations when evaluating treatment options with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, particularly for metastatic castration-resistant prostate cancer (mCRPC). Notable approvals include androgen receptor inhibitors like enzalutamide and apalutamide, and androgen synthesis inhibitors such as abiraterone acetate. Additionally, lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy, has been approved for PSMA-positive mCRPC. These treatments focus on inhibiting androgen receptor signaling or targeting specific molecular markers, similar to the mechanism of action being explored with Etrumadenant (AB928), which targets adenosine A2a and A2b receptors.

What other types of research exist?

Promising novel alternatives to Etrumadenant (AB928) for prostate cancer patients include: 1) Lutetium Lu 177 vipivotide tetraxetan, which has shown significant PSA decline and improved quality of life in metastatic castration-resistant prostate cancer (mCRPC) patients. 2) Darolutamide (ODM-201), a new-generation androgen receptor antagonist, which has demonstrated safety and efficacy in early-phase trials. 3) Bipolar Androgen Therapy (BAT), which has shown potential in restoring sensitivity to androgen receptor-targeted therapies in castration-resistant prostate cancer (CRPC).

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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years)

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

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

~5620

2017

N/A

~370

Etrumadenant

2018

Completed Phase 1

~130

Zimberelimab

2018

Completed Phase 1

~50

Enzalutamide

2014

Completed Phase 4

~2970

0 / 15Eligibility criteria met

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.