This trial will look at the safety and preliminary efficacy of SRF617 in combination with etrumadenant and zimberelimab in patients with metastatic castration-resistant prostate cancer (mCRPC).
This is a phase 2, open-label, safety and preliminary efficacy trial in patients with mCRPC using the combination of SRF617, etrumadenant (AB928), and zimberelimab (AB122).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
SRF617 is a fully human antibody designed to inhibit the enzymatic activity of CD39.
Etrumadenant is an A2aR and A2bR antagonist.
Zimberelimab is a fully human anti-PD-1 monoclonal antibody.
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Number of Participants With Response
Response was defined as Prostate-Specific Antigen (PSA) decline of ≥ 50% (PSA50) and/or radiographic objective response of Complete Response (CR) or Partial Response (PR) per Prostate Cancer Working Group 3 (PCWG3) Criteria. The number of participants with response shows participants with any one or combination of these response types. * CR: Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \< 10 millimeters (mm) in short axis * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum of diameters
Time frame: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)
Number of Participants With Response Per PCWG3 Criteria
The number of participants achieving CR or PR by PCWG3 criteria is reported: * CR: Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \< 10 millimeters (mm) in short axis * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum of diameters * Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions from the smallest value on trial (including Baseline, if that is the smallest). The sum of diameters must also demonstrate an absolute increase of at least 5 mm. Or, the appearance of one or more lesions * Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
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UT Southwestern
Dallas, Texas, United States
START South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
START Mountain Region, Utah Cancer Specialists
West Valley City, Utah, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
BC Cancer - The Vancouver Centre
Vancouver, British Columbia, Canada
Université de Montreal - Centre de Recherche du Centre Hospitalier de L'Université de Montreal (CRCHUM)
Montreal, Quebec, Canada
Time frame: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)
Duration of Response (DOR)
DOR was defined as the time from first documented response (PSA50 and/or CR/PR) to documented disease progression as determined by applicable disease criteria, or documented death due to any cause, whichever occured first.
Time frame: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)
Disease Control Rate (DCR)
DCR was defined as the percentage of participants with CR, PR, or SD lasting a minimum of 12 weeks by PCWG3 or PSA50 criteria.
Time frame: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)
Number of Participants With PSA50 Response
PSA50 response is defined as a confirmed PSA decrease from Baseline of 50% or more based on 2 consecutive assessments measured 3 to 4 weeks apart.
Time frame: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)
Number of Participants With PSA Decline of ≥ 30% (PSA30) Response
PSA30 response is defined as a confirmed PSA decrease from Baseline of 30% or more based on 2 consecutive assessments measured 3 to 4 weeks apart.
Time frame: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)
Time to PSA Progression
Time frame: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)
Radiographic Progression Free Survival (PFS)
Time frame: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)
Landmark PFS Rate
Landmark PFS was defined as the percentage of participants who have not developed PFS events of death or documented disease progression as determined by applicable disease criteria.
Time frame: Months 6 and 12
Maximum Observed Serum Concentration of SRF617 (Cmax)
Time frame: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)
Minimum Observed Serum Concentration of SRF617 Prior to Administration of Subsequent Dose (Cmin)
Time frame: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)
Number of Participants With Antidrug Antibodies (ADAs)
Time frame: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)
Number of Participants With Symptomatic Skeletal Events (SSEs)
Number of participants with SSEs per PCWG3 criteria, defined as symptomatic fracture, radiation or surgery to bone, or spinal cord compression, is reported.
Time frame: From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)