Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer
A Phase 1b/2, Open-Label, Randomized Platform Study Evaluating the Efficacy and Safety of AB928-Based Treatment Combinations in Patients With Metastatic Castrate Resistant Prostate Cancer
1 other identifier
interventional
173
2 countries
19
Brief Summary
This is a Phase 1b/2, open-label, multicenter platform trial to evaluate the antitumor activity and safety of etrumadenant (AB928)-based combination therapy in participants with metastatic castrate resistant prostate cancer (mCRPC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2020
Longer than P75 for phase_1
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2020
CompletedFirst Posted
Study publicly available on registry
May 11, 2020
CompletedStudy Start
First participant enrolled
July 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedJuly 22, 2025
September 1, 2024
4.2 years
May 6, 2020
July 18, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Objective Response Rate (ORR) in Stage 1 and 2
ORR defined as the composite proportion of participants with a Prostate Specific Antigen (PSA) and/or radiographic complete response (CR) and partial response (PR) determined by the investigator according to the Prostate Cancer Working Group 3 (PCWG3) criteria
From study enrolment until participant discontinuation, or first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 3-5 years)
Incidence and Severity of AEs and Serious Adverse Events (SAEs) in Stage 1
From first dose date to 90 days after the last dose (approximately 1.5 years)
Secondary Outcomes (10)
Percentage of participants with a PSA response in Stage 1 and 2
From study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years)
Percentage of participants with Radiographic Response in Stage 1 and 2
From study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years)
Percentage of Participants with Disease Control Rate in Stage 1 and 2
From study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years)
Serum/Plasma Concentration for etrumadenant, zimberelimab, and enzalutamide when administered as part of a combination regimen in Stage 1 and 2.
Recorded at baseline (enrollment), during the first 5 months of treatment and 3 additional timepoints in the first year of treatment. (approximately 1.5 years)
Serum/Plasma Concentration for etrumadenant and zimberelimab when administered as part of a combination regimen with docetaxel in Stage 1 and 2
Recorded at baseline (enrollment), during the first 5 months of treatment and 3 additional timepoints in the first year of treatment. (approximately 1.5 years)
- +5 more secondary outcomes
Study Arms (10)
Stage 1 and 2: Etrumadenant + zimberelimab + enzalutamide
EXPERIMENTALParticipants will receive oral etrumadenant in combination with intravenous (IV) zimberelimab and standard oral enzalutamide
Stage 2: enzalutamide
ACTIVE COMPARATORParticipants will receive standard oral enzalutamide
Stage 1 and 2: Etrumadenant + zimberelimab + docetaxel
EXPERIMENTALParticipants will receive oral etrumadenant in combination with IV zimberelimab and standard IV docetaxel
Stage 2: docetaxel
ACTIVE COMPARATORParticipants will receive standard dose of IV docetaxel
Stage 1 and 2: Etrumadenant + zimberelimab
EXPERIMENTALOral etrumadenant in combination IV zimberelimab
Stage 2: Etrumadenant + zimberelimab + quemliclustat
EXPERIMENTALParticipants will receive oral etrumadenant in combination with IV zimberelimab and IV quemliclustat
Stage 2: Etrumadenant + quemliclustat
EXPERIMENTALParticipants will receive oral etrumadenant in combination with IV quemliclustat
Stage 1: Etrumadenant + zimberelimab PK Sub-Study
EXPERIMENTALParticipants will receive oral etrumadenant in combination with IV zimberelimab
Stage 1 and 2: Etrumadenant + SG
EXPERIMENTALParticipants will receive oral etrumadenant in combination with IV SG.
Stage 1 and 2: Etrumadenant + Zimberelimab + SG
EXPERIMENTALParticipants will receive oral etrumadenant in combination with IV zimberelimab and SG.
Interventions
Etrumadenant is an A2aR and A2bR antagonist
Zimberelimab is an anti-PD-1 antibody
Quemliclustat is a Cluster of Differentiation (CD)73 Inhibitor.
Enzalutamide is an androgen receptor inhibitor
Docetaxel is type of chemotherapy
Sacituzumab govitecan is an antibody-drug conjugate
Eligibility Criteria
You may qualify if:
- Male participants; age ≥ 18 years
- 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 \[ng/dL\])
- Measurable or non-measurable disease as per radiographic evaluation
- Participants with measurable disease may require a fresh tumor biopsy at study entry
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate hematologic and end-organ function
- Human immunodeficiency virus (HIV), Hepatitis B, and C test results negative prior to first study treatment
- Disease progression after prior treatment with abiraterone
- Disease progression after prior androgen synthesis inhibitor therapy
- Disease progression after prior androgen synthesis inhibitor treatment and up to 2 prior lines of taxane chemotherapy
You may not qualify if:
- Prior treatment with immune checkpoint blockade therapy
- Prior anticancer treatment including approved agents, systemic radiotherapy, or investigational therapy, within 2-4 weeks prior first study treatment
- Corrected QT interval (QTc) ≥480 msec using Fredericia's QT correction formula (based on an average of triplicate recordings)
- Prior allogeneic stem cell or solid organ transplantation
- Prior treatment with drugs that stimulate the immune system within 4 weeks prior to first study treatment
- Prior treatment with drugs that suppress the immune system within 2 weeks prior to first study treatment
- Received a live, attenuated vaccine within 4 weeks prior to first study treatment, or may need to receive a vaccine during study treatment
- Presence of metastases in the brain or cancer spreading into the cerebrospinal fluid - CSF (leptomeningeal disease)
- Prior pulmonary fibrosis, pneumonia, or pneumonitis
- Cancer other than prostate within 2 years prior to study entry, except for some cancers with a low risk of spreading like non-melanoma skin
- Prior treatment with an agent targeting the adenosine pathway
- No oral or IV antibiotics within 2 weeks prior to first study treatment
- No severe infection within 4 weeks prior to first study treatment
- No clinically significant cardiac disease
- Inability to swallow medications
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arcus Biosciences, Inc.lead
- Gilead Sciencescollaborator
Study Sites (19)
The Oncology Institute of Hope & Innovation
Cerritos, California, 90703, United States
The University of California, Los Angeles
Encino, California, 91436, United States
The University of California, Irvine Medical Center
Orange, California, 92868, United States
Florida Cancer Specialists South
Sarasota, Florida, 34232, United States
Florida Cancer Specialists North
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists Panhandle
Tallahassee, Florida, 32308, United States
Florida Cancer Specialists East
West Palm Beach, Florida, 33401, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Affinity Health Hope & Healing Cancer Services
Hinsdale, Illinois, 60521, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
New York University, Langone Health
New York, New York, 01006, United States
Wilmot Cancer Institute Oncology, University of Rochester
Rochester, New York, 14642, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Tennessee Oncology - Chattanooga
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology - Nashville
Nashville, Tennessee, 37203, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane, Washington, 99208, United States
Juravinski Cancer Center
Hamilton, Ontario, L8V5C2, Canada
Centre hospitalier de l'Université de Montréal (CHUM) Centre de Recherche
Montreal, Quebec, H2X 3E4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Arcus Biosciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2020
First Posted
May 11, 2020
Study Start
July 7, 2020
Primary Completion
August 30, 2024
Study Completion
August 30, 2024
Last Updated
July 22, 2025
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.