- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05177770
Study of SRF617 With AB928 (Etrumadenent) and AB122 (Zimberelimab) in Patients With Metastatic Castration Resistant Prostate Cancer
A Phase 2 Trial of SRF617 in Combination With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration-Resistant Prostate Cancer
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Florida
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Miami, Florida, United States, 33136
- University of Miami - Sylvester Comprehensive Cancer Center
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Health System
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Nevada
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Las Vegas, Nevada, United States, 84119
- Comprehensive Cancer Centers of Nevada
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Texas
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Dallas, Texas, United States, 75390
- UT Southwestern
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San Antonio, Texas, United States, 78229
- START South Texas Accelerated Research Therapeutics, LLC
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Utah
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West Valley City, Utah, United States, 84119
- START Mountain Region, Utah Cancer Specialists
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Washington
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Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥ 18 years of age.
- Metastatic CRPC with castrate levels of testosterone (≤ 50 ng/dL or ≤ 1.7 nmol/L).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Progressed (by PSA or radiologic criteria) during or following treatment with a novel androgen receptor signaling inhibitor (ARSI, eg, abiraterone, enzalutamide, apalutamide, darolutamide), which may have been given for either hormone-sensitive prostate cancer or CRPC.
- Received 1 to 2 prior lines of taxane chemotherapy, unless the physician and patient believe the patient is medically ineligible or the patient refuses (ineligibility or refusal must be documented in the source documents).
- Progressed by PSA or radiologic criteria on or during last therapy for prostate cancer.
Measurable or non-measurable disease as per radiographic evaluation. Lesions situated in a previously irradiated area are considered evaluable if progression has been demonstrated in such lesions since radiation.
• Note: If disease is considered non-measurable, a minimum PSA of 1 ng/dL is required with at least 1 confirmed rise at a minimum of a 1-week interval.
- Adequate hematologic function, defined as absolute neutrophil count ≥ 1.5 × 109/L, hemoglobin ≥ 9.0 g/dL, and platelet count ≥ 100 × 109/L. Transfusions are permitted to meet hemoglobin and platelet criteria. However, the patient must have a stable hemoglobin level and platelet count for ≥ 2 weeks prior to dosing without transfusion.
- Adequate renal function, defined as serum creatinine clearance ≥ 30 mL/min per Cockcroft-Gault formula.
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (≤ 3 × ULN if elevated because of Gilbert's syndrome, and ≤ 2 × ULN for patients with known liver metastases).
- Aspartate aminotransferase and alanine aminotransferase < 2.5 × ULN (< 5 × ULN if liver metastases present).
- Prothrombin time (PT) or international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless the patient is receiving anticoagulant therapy, in which case PT/INR or aPTT must be within therapeutic range of intended use of anticoagulants.
Exclusion Criteria:
- Currently participating in or has participated in a trial of an investigational device or has used an investigational device within 21 days before the first dose of study drug.
- Any component of small cell or neuroendocrine histology.
- Previously received an anti-CD39 antibody, anti-CD39 targeted therapy, or other agent targeting the adenosine pathway.
- Prior treatment with programmed death-ligand 1 (PD-L1)/programmed death receptor-1 (PD-1) inhibitors.
- Prior treatment with ≥ 3 lines of taxane chemotherapy administered as a single agent or as part of a combination regimen.
- Symptomatic or untreated brain metastases (including leptomeningeal metastases). Patients previously treated for brain metastases must be at least 4 weeks from completion of radiation treatment with follow-up imaging showing no progression.
- Current pneumonitis with or without steroid requirement or history of pneumonitis requiring steroids.
- Another malignancy other than prostate within 2 years of trial entry, except for those with a low risk of spreading or negligible risk of death such as non-melanoma skin cancer or Ta superficial bladder cancer.
- Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
Medical conditions requiring chronic steroid (ie, > 10 mg/day of prednisone or its equivalent).
• Note: Replacement therapy (eg, levothyroxine, insulin, or physiologic corticosteroid replacement therapy for thyroid, adrenal, or pituitary insufficiency) is allowed.
Administration of a live attenuated vaccine within 6 weeks before the first dose of study drug.
• Exception: Health Authority approved COVID-19 vaccines are permitted.
- Any gastrointestinal condition that would preclude the use of oral medications (eg, difficulty swallowing, nausea, vomiting, or malabsorption).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SRF617 in combination with etrumadenant and zimberelimab
All patients will receive SRF617 administered in combination with etrumadenant (AB928) and zimberelimab (AB122).
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Etrumadenant is an A2aR and A2bR antagonist.
Other Names:
SRF617 is a fully human antibody designed to inhibit the enzymatic activity of CD39.
Zimberelimab is a fully human anti-PD-1 monoclonal antibody.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of patients with an objective PSA (prostate-specific antigen) or radiologic response per PCWG3 criteria
Time Frame: Up to 24 months
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The proportion of patients with a response, defined as PSA50 response (≥50% decline) and/or radiographic objective response of CR or PR per PCWG3 criteria
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Up to 24 months
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Incidence and severity of adverse events (AEs) based on treatment-emergent AEs (TEAEs)
Time Frame: Up to 24 months
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Incidence and severity of adverse events (AEs) based on treatment-emergent AEs (TEAEs).
A TEAE is an AE that emerges or worsens in the period from the first dose of study drug to 30 days after the last dose of SRF617, 30 days after the last dose of etrumadenant, or 90 days after the last dose of zimberelimab (30 days after the last dose of zimberelimab if the patient starts another anticancer therapy), whichever is later
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Up to 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR)
Time Frame: Up to 24 months
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Assessed radiographically by PCWG3 criteria and RECIST v1.1
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Up to 24 months
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Duration of response (DOR)
Time Frame: Up to 24 months
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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 occurs first
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Up to 24 months
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Disease control rate (DCR)
Time Frame: Up to 24 months
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Percentage of patients with complete response (PR), partial response (PR), or stable disease lasting a minimum of 12 weeks
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Up to 24 months
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PSA50 response
Time Frame: Up to 24 months
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Confirmed PSA decrease from Baseline of 50% or more
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Up to 24 months
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PSA decline
Time Frame: Up to 24 months
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Changes in PSA across the trial period
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Up to 24 months
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Time to PSA progression
Time Frame: Up to 24 months
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Changes in PSA across the trial period
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Up to 24 months
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Radiographic progression free survival (PFS)
Time Frame: Up to 24 months
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PFS is defined as the time from the first treatment on trial with study drug to documented disease progression as determined by applicable disease criteria or death
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Up to 24 months
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Landmark PFS
Time Frame: Up to 24 months
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Landmark PFS, defined as the percentage of patients who have not developed PFS events (ie, death or documented disease progression as determined by applicable disease criteria) at 6 months, 12 months, 18 months, and 24 months
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Up to 24 months
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Maximum observed serum concentration of SRF617 (Cmax)
Time Frame: Up to 24 months
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Serum samples will be collected and analyzed to assess the Cmax of SRF617
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Up to 24 months
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Minimum observed serum concentration of SRF617 prior to administration of subsequent dose (Cmin)
Time Frame: Up to 24 months
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Serum samples will be collected and analyzed to assess the Cmin of SRF617
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Up to 24 months
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Antidrug Antibodies (ADAs)
Time Frame: Up to 24 months
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Percentage of patients with ADAs to SRF617
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Up to 24 months
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Symptomatic Skeletal Events (SSEs)
Time Frame: Up to 24 months
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Incidence of SSEs per PCWG3 criteria
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Up to 24 months
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRF617-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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