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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
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
ARC-6 Trial Summary
This trial is testing a new cancer drug, etrumadenant, to see if it is safe and effective at treating metastatic castrate resistant 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.Check my eligibility
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.See study design
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.
ARC-6 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
ARC-6 Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and Severity of AEs and Serious Adverse Events (SAEs) in Stage 1
Objective Response Rate (ORR) in Stage 1 and 2
Secondary outcome measures
Incidence and severity of AEs and serious adverse events (SAEs) in Stage 2
Percentage of Participants with Disease Control Rate in Stage 1 and 2
Percentage of participants with Radiographic Response in Stage 1 and 2
+7 moreARC-6 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
SG
2017
N/A
~370
Etrumadenant
2018
Completed Phase 1
~130
Zimberelimab
2018
Completed Phase 1
~50
Enzalutamide
2014
Completed Phase 4
~2760
Find a Location
Who is running the clinical trial?
Arcus Biosciences, Inc.Lead Sponsor
41 Previous Clinical Trials
5,893 Total Patients Enrolled
1 Trials studying Prostate Cancer
15 Patients Enrolled for Prostate Cancer
Gilead SciencesIndustry Sponsor
1,082 Previous Clinical Trials
842,668 Total Patients Enrolled
2 Trials studying Prostate Cancer
255 Patients Enrolled for Prostate Cancer
Medical DirectorStudy DirectorArcus Biosciences
2,777 Previous Clinical Trials
8,063,307 Total Patients Enrolled
13 Trials studying Prostate Cancer
3,306 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer has spread and does not respond to hormone therapy.I am a man aged 18 or older.I have been treated with immune checkpoint inhibitors before.I cannot swallow pills.I am fully active or restricted in physically strenuous activity but can do light work.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I have been treated with medication targeting the adenosine pathway before.I haven't taken immune-suppressing drugs in the last 2 weeks.I haven't had cancer treatment, including trials or radiation, in the last 2-4 weeks.I haven't had a severe infection in the last 4 weeks.My heart is healthy without major issues.I have had lung fibrosis, pneumonia, or pneumonitis before.I haven't taken any antibiotics in the last 2 weeks.My cancer progressed after treatment with abiraterone.My cancer has spread to my brain or into the fluid around my brain and spinal cord.I may need a new tumor biopsy to join the study.My blood and organs are functioning well.My cancer progressed after treatment to lower male hormones.I haven't taken immune-stimulating drugs in the last 4 weeks.I have had a previous transplant of stem cells or an organ.I haven't had any cancer other than prostate or low-risk skin cancer in the last 2 years.My cancer progressed after hormone therapy and I've had up to 2 taxane chemotherapies.
Research Study Groups:
This trial has the following groups:- Group 1: Stage 1 and 2: Etrumadenant + zimberelimab + enzalutamide
- Group 2: Stage 1 and 2: Etrumadenant + zimberelimab
- Group 3: Stage 1: Etrumadenant + zimberelimab PK Sub-Study
- Group 4: Stage 1 and 2: Etrumadenant + SG
- Group 5: Stage 2: Etrumadenant + quemliclustat
- Group 6: Stage 1 and 2: Etrumadenant + zimberelimab + docetaxel
- Group 7: Stage 2: docetaxel
- Group 8: Stage 2: enzalutamide
- Group 9: Stage 2: Etrumadenant + zimberelimab + quemliclustat
- Group 10: Stage 1 and 2: Etrumadenant + Zimberelimab + SG
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the typical applications of AB680?
"AB680 is widely used to treat cancerous tumours, as well as advance directives, sarcoma and malignant esophageal neoplasms."
Answered by AI
How many venues is this medical experiment currently in progress?
"Northwestern University Feinberg School of Medicine in Chicago, Illinois, Centre hospitalier de l'Université de Montréal (CHUM) Centre de Recherche in Montréal, Quebec and the University of Wisconsin Carbone Cancer Center in Madison, Wisconsin are just a few from the 20 medical sites that have been selected to operate this trial."
Answered by AI
Has AB680 been the subject of any prior investigations?
"Presently, 403 medical trials researching AB680 are in progress with 150 of these studies at Phase 3. Though the majority of experiments for this drug take place in Germantown, Tennessee, there are 27508 research centres conducting clinical trials on AB680 globally."
Answered by AI
How many people are eligible to participate in this clinical investigation?
"Subsequently, this study necessitates the inclusion of 342 patients that fulfill certain qualifications. Potential participants can take part in either Northwestern University Feinberg School of Medicine located in Chicago or Centre hospitalier de l'Université de Montréal (CHUM) Centre de Recherche situated in Montréal."
Answered by AI
Is recruitment for this research endeavor still in progress?
"Affirmative. Clinicaltrials.gov attests to this ongoing trial's search for participants, which began on July 7th 2020 and was recently updated November 7th 2022. 342 patients are needed from 20 different medical facilities in order to adequately execute the study."
Answered by AI
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