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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05177770
Recruitment Status : Active, not recruiting
First Posted : January 5, 2022
Last Update Posted : November 30, 2022
Sponsor:
Collaborator:
Arcus Biosciences, Inc.
Information provided by (Responsible Party):
Surface Oncology

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).

Condition or disease Intervention/treatment Phase
Metastatic Castration-resistant Prostate Cancer Prostate Cancer Drug: SRF617 Drug: etrumadenant Drug: zimberelimab Phase 2

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial of SRF617 in Combination With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration-Resistant Prostate Cancer
Actual Study Start Date : January 17, 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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

Drug: etrumadenant
Etrumadenant is an A2aR and A2bR antagonist.
Other Name: AB928

Drug: zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody.
Other Name: AB122




Primary Outcome Measures :
  1. The proportion of patients with an objective PSA (prostate-specific antigen) or radiologic response per PCWG3 criteria [ Time Frame: Up to 24 months ]
    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

  2. Incidence and severity of adverse events (AEs) based on treatment-emergent AEs (TEAEs) [ Time Frame: Up to 24 months ]
    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


Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Up to 24 months ]
    Assessed radiographically by PCWG3 criteria and RECIST v1.1

  2. Duration of response (DOR) [ Time Frame: Up to 24 months ]
    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

  3. Disease control rate (DCR) [ Time Frame: Up to 24 months ]
    Percentage of patients with complete response (PR), partial response (PR), or stable disease lasting a minimum of 12 weeks

  4. PSA50 response [ Time Frame: Up to 24 months ]
    Confirmed PSA decrease from Baseline of 50% or more

  5. PSA decline [ Time Frame: Up to 24 months ]
    Changes in PSA across the trial period

  6. Time to PSA progression [ Time Frame: Up to 24 months ]
    Changes in PSA across the trial period

  7. Radiographic progression free survival (PFS) [ Time Frame: Up to 24 months ]
    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

  8. Landmark PFS [ Time Frame: Up to 24 months ]
    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

  9. Maximum observed serum concentration of SRF617 (Cmax) [ Time Frame: Up to 24 months ]
    Serum samples will be collected and analyzed to assess the Cmax of SRF617

  10. Minimum observed serum concentration of SRF617 prior to administration of subsequent dose (Cmin) [ Time Frame: Up to 24 months ]
    Serum samples will be collected and analyzed to assess the Cmin of SRF617

  11. Antidrug Antibodies (ADAs) [ Time Frame: Up to 24 months ]
    Percentage of patients with ADAs to SRF617

  12. Symptomatic Skeletal Events (SSEs) [ Time Frame: Up to 24 months ]
    Incidence of SSEs per PCWG3 criteria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05177770


Locations
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United States, Florida
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 84119
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
START South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
United States, Utah
START Mountain Region, Utah Cancer Specialists
West Valley City, Utah, United States, 84119
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Surface Oncology
Arcus Biosciences, Inc.
Investigators
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Study Chair: Lauren Harshman, MD Surface Oncology
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Responsible Party: Surface Oncology
ClinicalTrials.gov Identifier: NCT05177770    
Other Study ID Numbers: SRF617-201
First Posted: January 5, 2022    Key Record Dates
Last Update Posted: November 30, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Surface Oncology:
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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases