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Prostatic Neoplasms, Castration-ResistantPhase 1/2NCT04381832

Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer

A Phase 1/2 study testing Etrumadenant, Zimberelimab and Quemliclustat in people with Prostatic Neoplasms, Castration-Resistant and Androgen-Resistant Prostatic Neoplasms, run by Arcus Biosciences, Inc. at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Etrumadenant, Zimberelimab and Quemliclustat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
173 participants
Where
19 sitesin 2 countries
Study dates
7 Jul 2020to 30 Aug 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Disease progression after prior androgen synthesis inhibitor treatment and up to 2 prior lines of taxane chemotherapy
  • General Exclusion Criteria:
  • 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
Show all 28Show fewer
  • 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
  • Exclusion Criteria for Participants receiving an enzalutamide-containing treatment
  • Prior treatment with docetaxel, cabazitaxel, or other taxane chemotherapy (prior docetaxel [up to 6 cycles] for hormone-sensitive prostate cancer is allowed if the last dose was at least 6 months prior to study treatment initiation)
  • Prior treatment with enzalutamide or similar therapy other than abiraterone
  • 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
  • Exclusion Criteria for Participants receiving a docetaxel-containing treatment
  • Prior treatment with docetaxel, cabazitaxel, 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

Who cannot join

  • 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

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

United States17 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • The Oncology Institute of Hope & Innovation

    Cerritos, California, 90703

  • Tennessee Oncology - Chattanooga

    Chattanooga, Tennessee, 37404

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The University of California, Los Angeles

    Encino, California, 91436

  • Affinity Health Hope & Healing Cancer Services

    Hinsdale, Illinois, 60521

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Tennessee Oncology - Nashville

    Nashville, Tennessee, 37203

  • New York University, Langone Health

    New York, New York, 01006

  • The University of California, Irvine Medical Center

    Orange, California, 92868

  • Wilmot Cancer Institute Oncology, University of Rochester

    Rochester, New York, 14642

  • Florida Cancer Specialists South

    Sarasota, Florida, 34232

  • Medical Oncology Associates, PS (dba Summit Cancer Centers)

    Spokane, Washington, 99208

  • Florida Cancer Specialists North

    St. Petersburg, Florida, 33705

  • Florida Cancer Specialists Panhandle

    Tallahassee, Florida, 32308

  • Florida Cancer Specialists East

    West Palm Beach, Florida, 33401

Other trials in United States

Canada2 sites

  • Juravinski Cancer Center

    Hamilton, Ontario, L8V5C2

  • Centre hospitalier de l'Université de Montréal (CHUM) Centre de Recherche

    Montreal, Quebec, H2X 3E4

Other trials in Canada

About this study

Official title: 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

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).

Being tested
Etrumadenant, Zimberelimab, Quemliclustat, Enzalutamide, Docetaxel
Medical subject headings
Prostatic Neoplasms, Castration-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtrumadenantDrug

    Also called AB928

    Etrumadenant is an A2aR and A2bR antagonist

  • ZimberelimabDrug

    Also called AB122

    Zimberelimab is an anti-PD-1 antibody

  • QuemliclustatDrug

    Also called AB680

    Quemliclustat is a Cluster of Differentiation (CD)73 Inhibitor.

  • EnzalutamideDrug

    Also called Xtandi

    Enzalutamide is an androgen receptor inhibitor

  • DocetaxelDrug

    Also called Taxotere

    Docetaxel is type of chemotherapy

  • SGDrug

    Also called Trodelvy

    Sacituzumab govitecan is an antibody-drug conjugate

Study groups in NCT04381832
Study groupRoleWhat they receive
Stage 1 and 2: Etrumadenant + zimberelimab + enzalutamideExperimentalParticipants will receive oral etrumadenant in combination with intravenous (IV) zimberelimab and standard oral enzalutamide
Receives: Drug: Etrumadenant; Drug: Zimberelimab; Drug: Enzalutamide
Stage 2: enzalutamideActive comparatorParticipants will receive standard oral enzalutamide
Receives: Drug: Enzalutamide
Stage 1 and 2: Etrumadenant + zimberelimab + docetaxelExperimentalParticipants will receive oral etrumadenant in combination with IV zimberelimab and standard IV docetaxel
Receives: Drug: Etrumadenant; Drug: Zimberelimab; Drug: Docetaxel
Stage 2: docetaxelActive comparatorParticipants will receive standard dose of IV docetaxel
Receives: Drug: Docetaxel
Stage 1 and 2: Etrumadenant + zimberelimabExperimentalOral etrumadenant in combination IV zimberelimab
Receives: Drug: Etrumadenant; Drug: Zimberelimab
Stage 2: Etrumadenant + zimberelimab + quemliclustatExperimentalParticipants will receive oral etrumadenant in combination with IV zimberelimab and IV quemliclustat
Receives: Drug: Etrumadenant; Drug: Zimberelimab; Drug: Quemliclustat
Stage 2: Etrumadenant + quemliclustatExperimentalParticipants will receive oral etrumadenant in combination with IV quemliclustat
Receives: Drug: Etrumadenant; Drug: Quemliclustat
Stage 1: Etrumadenant + zimberelimab PK Sub-StudyExperimentalParticipants will receive oral etrumadenant in combination with IV zimberelimab
Receives: Drug: Etrumadenant; Drug: Zimberelimab
Stage 1 and 2: Etrumadenant + SGExperimentalParticipants will receive oral etrumadenant in combination with IV SG.
Receives: Drug: Etrumadenant; Drug: SG
Stage 1 and 2: Etrumadenant + Zimberelimab + SGExperimentalParticipants will receive oral etrumadenant in combination with IV zimberelimab and SG.
Receives: Drug: Etrumadenant; Drug: Zimberelimab; Drug: SG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From study enrolment until participant discontinuation, or first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 3-5 years)

  2. Incidence and Severity of AEs and Serious Adverse Events (SAEs) in Stage 1

    Measured: From first dose date to 90 days after the last dose (approximately 1.5 years)

Secondary outcomes (10)

  1. Percentage of participants with a PSA response in Stage 1 and 2

    PSA response defined as the proportion of participants with a confirmed PSA decrease from baseline of 50% or more based on two consecutive assessments measured 3 to 4 weeks apart

    Measured: From study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years)

  2. Percentage of participants with Radiographic Response in Stage 1 and 2

    Radiographic Response is measurable disease at baseline who achieved a best overall response of CR or PR according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: From study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years)

  3. Percentage of Participants with Disease Control Rate in Stage 1 and 2

    Disease Control Rate is defined as the percentage of participants with measurable disease at baseline who achieved a best overall RECIST response of CR, PR, or Stable Disease (SD).

    Measured: From study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years)

  4. Serum/Plasma Concentration for etrumadenant, zimberelimab, and enzalutamide when administered as part of a combination regimen in Stage 1 and 2.

    Measured: 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. Serum/Plasma Concentration for etrumadenant and zimberelimab when administered as part of a combination regimen with docetaxel in Stage 1 and 2

    Measured: 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)

  6. Serum/Plasma Concentration for etrumadenant and zimberelimab when administered as part of a combination regimen in Stage 1 and 2

    Measured: 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)

  7. Serum/Plasma Concentration for etrumadenant, zimberelimab, and AB680 when administered as part of a combination regimen in Stage 1 and 2

    Measured: 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)

  8. Serum/Plasma Concentration for etrumadenant and AB680 when administered as part of a combination regimen in Stage 1 and 2.

    Measured: 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)

  9. Percentage of participants with anti-drug antibodies to zimberelimab in Stage 1 and 2

    Measured: Recorded at baseline (enrollment), during the first 4 months of treatment, 4 additional timepoints in the first year of treatment, and at end of treatment. (approximately 1.5 years)

  10. Incidence and severity of AEs and serious adverse events (SAEs) in Stage 2

    Measured: From first dose date to 90 days after the last dose (approximately 3-5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2020
  2. Study start7 Jul 2020
  3. Primary completion30 Aug 2024
  4. Study completion30 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04381832
Sponsor's protocol ID
ARC-6
Status last verified
Sep 2024
First submitted
6 May 2020
Last updated
22 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Etrumadenant, Zimberelimab and Quemliclustat in people with Prostatic Neoplasms, Castration-Resistant and Androgen-Resistant Prostatic Neoplasms, run by Arcus Biosciences, Inc. at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) in Stage 1 and 2 (time frame: From study enrolment until participant discontinuation, or first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 3-5 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04381832.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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