Prostatic Neoplasms, Castration-Resistant Clinical Trial
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
Verified date | May 2024 |
Source | Arcus Biosciences, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 173 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Juravinski Cancer Center | Hamilton | Ontario |
Canada | Centre hospitalier de l'Université de Montréal (CHUM) Centre de Recherche | Montréal | Quebec |
United States | Johns Hopkins University | Baltimore | Maryland |
United States | The Oncology Institute of Hope & Innovation | Cerritos | California |
United States | Tennessee Oncology - Chattanooga | Chattanooga | Tennessee |
United States | Northwestern University Feinberg School of Medicine | Chicago | Illinois |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | The University of California, Los Angeles | Encino | California |
United States | Affinity Health Hope & Healing Cancer Services | Hinsdale | Illinois |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin |
United States | Tennessee Oncology - Nashville | Nashville | Tennessee |
United States | New York University, Langone Health | New York | New York |
United States | The University of California, Irvine Medical Center | Orange | California |
United States | Wilmot Cancer Institute Oncology, University of Rochester | Rochester | New York |
United States | Florida Cancer Specialists North | Saint Petersburg | Florida |
United States | The University of California, San Francisco | San Francisco | California |
United States | Florida Cancer Specialists South | Sarasota | Florida |
United States | Medical Oncology Associates, PS (dba Summit Cancer Centers) | Spokane | Washington |
United States | Florida Cancer Specialists Panhandle | Tallahassee | Florida |
United States | Florida Cancer Specialists East | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Arcus Biosciences, Inc. | Gilead Sciences |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | 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 | From study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years) | |
Secondary | 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 | From study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years) | |
Secondary | 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). | From study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years) | |
Secondary | 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) | ||
Secondary | 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) | ||
Secondary | Serum/Plasma Concentration for etrumadenant and zimberelimab 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) | ||
Secondary | Serum/Plasma Concentration for etrumadenant, zimberelimab, and AB680 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) | ||
Secondary | Serum/Plasma Concentration for etrumadenant and AB680 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) | ||
Secondary | Percentage of participants with anti-drug antibodies to zimberelimab in Stage 1 and 2 | 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) | ||
Secondary | Incidence and severity of AEs and serious adverse events (SAEs) in Stage 2 | From first dose date to 90 days after the last dose (approximately 3-5 years) |
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