Study of SRF617 With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration Resistant Prostate Cancer

NCT05177770 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: SRF617-201
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 9

Brief Summary

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).

Conditions

Metastatic Castration-resistant Prostate Cancer; Prostate Cancer

Keywords

mCRPC; metastatic castration-resistant prostate cancer; prostate cancer; CD-39; PD-1; A2a; A2b; SRF617; AB122; AB928; adenosine pathway; cancer; immunotherapy; phase 2; efficacy; checkpoint inhibitor; adenosine receptor antagonist

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)

Secondary Outcomes (12)

• Number of Participants With Response Per PCWG3 Criteria

  From the date of first dose administration to the end of treatment (maximum exposure: 168 days)

• Duration of Response (DOR)

  From the date of first dose administration to the end of treatment (maximum exposure: 168 days)

• Disease Control Rate (DCR)

  From the date of first dose administration to the end of treatment (maximum exposure: 168 days)

• Number of Participants With PSA50 Response

  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

  From the date of first dose administration to the end of treatment (maximum exposure: 168 days)

Study Arms (1)

SRF617 in combination with etrumadenant and zimberelimab

EXPERIMENTAL

All patients will receive SRF617 administered in combination with etrumadenant (AB928) and zimberelimab (AB122).

Drug: SRF617; Drug: etrumadenant; Drug: zimberelimab

Interventions

SRF617 DRUG

SRF617 is a fully human antibody designed to inhibit the enzymatic activity of CD39.

SRF617 in combination with etrumadenant and zimberelimab

etrumadenant DRUG

Etrumadenant is an A2aR and A2bR antagonist.

Also known as: AB928

SRF617 in combination with etrumadenant and zimberelimab

zimberelimab DRUG

Zimberelimab is a fully human anti-PD-1 monoclonal antibody.

Also known as: AB122

SRF617 in combination with etrumadenant and zimberelimab

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Coherus Oncology, Inc.: lead
• Arcus Biosciences, Inc.: collaborator
• Surface Oncology: collaborator

Study Sites (9)

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 84119, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

START South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229, United States

Location

START Mountain Region, Utah Cancer Specialists

West Valley City, Utah, 84119, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

BC Cancer - The Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Université de Montreal - Centre de Recherche du Centre Hospitalier de L'Université de Montreal (CRCHUM)

Montreal, Quebec, H2X 0A9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

zimberelimab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

This study was originally intended to be conducted in 2 stages (1 and 2); however, a strategic decision was made to terminate the study during Stage 1.

Results Point of Contact

• Title: Allison Intondi, Vice President, Clinical Operations
• Organization: Coherus BioSciences

ClinicalTrials@Coherus.com

800-794-5434

Study Officials

• Vienna Reichert, PhD

  Coherus BioSciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: January 5, 2022
• Study Start: January 17, 2022
• Primary Completion: April 5, 2023
• Study Completion: April 5, 2023
• Last Updated: May 8, 2025
• Results First Posted: May 17, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); CA (2)