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Metastatic Castration-resistant Prostate CancerPhase 2NCT05177770

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

A Phase 2 study testing SRF617, etrumadenant and zimberelimab in people with Metastatic Castration-resistant Prostate Cancer and Prostate Cancer, run by Coherus Oncology, Inc. at 9 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
SRF617, etrumadenant and zimberelimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
9 sitesin 2 countries
Study dates
17 Jan 2022to 5 Apr 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

United States7 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • UT Southwestern

    Dallas, Texas, 75390

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 84119

  • University of Miami - Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • START South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas, 78229

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • START Mountain Region, Utah Cancer Specialists

    West Valley City, Utah, 84119

Other trials in United States

Canada2 sites

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

    Montreal, Quebec, H2X 0A9

  • BC Cancer - The Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: A Phase 2 Trial of SRF617 in Combination With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration-Resistant Prostate Cancer

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).

Read the 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).

Being tested
SRF617, etrumadenant, zimberelimab
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
Medical subject headings
Prostatic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SRF617Drug

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

  • etrumadenantDrug

    Also called AB928

    Etrumadenant is an A2aR and A2bR antagonist.

  • zimberelimabDrug

    Also called AB122

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

Study groups in NCT05177770
Study groupRoleWhat they receive
SRF617 in combination with etrumadenant and zimberelimabExperimentalAll patients will receive SRF617 administered in combination with etrumadenant (AB928) and zimberelimab (AB122).
Receives: Drug: SRF617; Drug: etrumadenant; Drug: zimberelimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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.

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

Secondary outcomes (12)

  1. 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

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. Time to PSA Progression

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

  7. Radiographic Progression Free Survival (PFS)

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

  8. 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.

    Measured: Months 6 and 12

  9. Maximum Observed Serum Concentration of SRF617 (Cmax)

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

  10. Minimum Observed Serum Concentration of SRF617 Prior to Administration of Subsequent Dose (Cmin)

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

  11. Number of Participants With Antidrug Antibodies (ADAs)

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

  12. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2022
  2. Study start17 Jan 2022
  3. Primary completion5 Apr 2023
  4. Study completion5 Apr 2023

Why it stopped: The study was terminated for strategic reasons, not due to any safety concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05177770
Sponsor's protocol ID
SRF617-201
Status last verified
Apr 2025
First submitted
5 Dec 2021
Last updated
8 May 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SRF617, etrumadenant and zimberelimab in people with Metastatic Castration-resistant Prostate Cancer and Prostate Cancer, run by Coherus Oncology, Inc. at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Response (time frame: From the date of first dose administration to the end of treatment (maximum exposure: 168 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05177770.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.

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