Prostate Cancer Clinical Trial

Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer

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).

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Full Description

This study has several treatment arms and each treatment arm has 2 stages. During Stage 1 - Etrumadenant plus zimberelimab (AB122) alone, etrumadenant plus zimberelimab with or without a standard of care treatment (enzalutamide or docetaxel), or etrumadenant plus AB680 with or without zimberelimab, or etrumadenant plus Sacituzumab govitecan (SG) alone or etrumadenant plus zimberelimab plus SG will be administered to participants with mCRPC.

During Stage 2 - Additional participants with mCRPC may receive an etrumadenant-based combination therapy evaluated in Stage 1 or, a standard of care treatment.

A pharmacokinetic (PK) Sub-Study (etrumadenant plus zimberelimab) will be conducted separately.

Treatment may continue until unacceptable toxicity or progressive disease, or other reasons specified in the protocol.

View Eligibility Criteria

Eligibility Criteria

General Inclusion Criteria:

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

Inclusion Criteria for Participants receiving an enzalutamide-containing treatment

Disease progression after prior treatment with abiraterone

Inclusion Criteria for Participants receiving a docetaxel-containing treatment

Disease progression after prior androgen synthesis inhibitor therapy

Inclusion Criteria for all other Participants

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
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

Exclusion Criteria for 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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

342

Study ID:

NCT04381832

Recruitment Status:

Recruiting

Sponsor:

Arcus Biosciences, Inc.

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There are 20 Locations for this study

See Locations Near You

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
The University of California, San Francisco
San Francisco California, 94158, United States
Florida Cancer Specialists North
Saint Petersburg Florida, 33705, United States
Florida Cancer Specialists South
Sarasota Florida, 34232, 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
Johns Hopkins University
Baltimore Maryland, 21287, United States
New York University, Langone Health
New York New York, 10016, 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
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53792, United States
Juravinski Cancer Center
Hamilton Ontario, L8V5C, Canada
Centre hospitalier de l'Université de Montréal (CHUM) Centre de Recherche
Montréal Quebec, H2X 3, Canada

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

342

Study ID:

NCT04381832

Recruitment Status:

Recruiting

Sponsor:


Arcus Biosciences, Inc.

How clear is this clinincal trial information?

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