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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
173
Etrumadenant is an A2aR and A2bR antagonist
Zimberelimab is an anti-PD-1 antibody
Quemliclustat is a Cluster of Differentiation (CD)73 Inhibitor.
The Oncology Institute of Hope & Innovation
Cerritos, California, United States
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
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)
Incidence and Severity of AEs and Serious Adverse Events (SAEs) in Stage 1
Time frame: From first dose date to 90 days after the last dose (approximately 1.5 years)
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
Time frame: 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
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
Time frame: 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
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).
Time frame: From study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Enzalutamide is an androgen receptor inhibitor
Docetaxel is type of chemotherapy
Sacituzumab govitecan is an antibody-drug conjugate
The University of California, Los Angeles
Encino, California, United States
The University of California, Irvine Medical Center
Orange, California, United States
Florida Cancer Specialists South
Sarasota, Florida, United States
Florida Cancer Specialists North
St. Petersburg, Florida, United States
Florida Cancer Specialists Panhandle
Tallahassee, Florida, United States
Florida Cancer Specialists East
West Palm Beach, Florida, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Affinity Health Hope & Healing Cancer Services
Hinsdale, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
...and 9 more locations
Serum/Plasma Concentration for etrumadenant, zimberelimab, and enzalutamide when administered as part of a combination regimen in Stage 1 and 2.
Time frame: 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
Time frame: 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 in Stage 1 and 2
Time frame: 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, zimberelimab, and AB680 when administered as part of a combination regimen in Stage 1 and 2
Time frame: 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 AB680 when administered as part of a combination regimen in Stage 1 and 2.
Time frame: 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)
Percentage of participants with anti-drug antibodies to zimberelimab in Stage 1 and 2
Time frame: 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)
Incidence and severity of AEs and serious adverse events (SAEs) in Stage 2
Time frame: From first dose date to 90 days after the last dose (approximately 3-5 years)