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NCT05177770

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

Terminated Phase 2 Results posted Last updated 8 May 2025
What this trial tests

Phase 2 trial testing SRF617 in Metastatic Castration-resistant Prostate Cancer in 16 participants. Terminated before completion.

Timeline
17 January 2022
Primary endpoint
5 April 2023
5 April 2023

Quick facts

Lead sponsorCoherus Oncology, Inc.
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment16
Start date17 January 2022
Primary completion5 April 2023
Estimated completion5 April 2023
Sites9 locations across Canada, United States

Drugs / interventions tested

Conditions studied

Sponsor

Coherus Oncology, Inc. — full company profile →

Who can join

18 and older, male only, with Metastatic Castration-resistant Prostate Cancer or Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Response Primary · From the date of first dose administration to the end of treatment (maximum exposure: 168 days)

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 diame

GroupValue95% CI
SRF617 + Etrumadenant + Zimberelimab0
Number of Participants With Adverse Events (AEs) Primary · From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)

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

GroupValue95% CI
SRF617 + Etrumadenant + Zimberelimab15
Number of Participants With PSA50 Response Secondary · From the date of first dose administration to the end of treatment (maximum exposure: 168 days)

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.

GroupValue95% CI
SRF617 + Etrumadenant + Zimberelimab0
Number of Participants With Symptomatic Skeletal Events (SSEs) Secondary · From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days)

Number of participants with SSEs per PCWG3 criteria, defined as symptomatic fracture, radiation or surgery to bone, or spinal cord compression, is reported.

GroupValue95% CI
SRF617 + Etrumadenant + Zimberelimab4

Adverse events — posted to ClinicalTrials.gov

Time frame: From date of first dose until 90 days after the last dose of treatment (maximum treatment exposure: 168 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SRF617 + Etrumadenant + Zimberelimab
Serious: 7/16 (44%)
Deaths: 4/16

Serious adverse events (9 terms)

ReactionSystemSRF617 + Etrumadenant + Zi…
Spinal cord compressionNervous system disorders
AnaemiaBlood and lymphatic system disorders
Acute myocardial infarctionCardiac disorders
Cardiogenic shockCardiac disorders
Disease progressionGeneral disorders
Cytokine release syndromeImmune system disorders
PneumoniaInfections and infestations
Back painMusculoskeletal and connective tissue disorders
Tumor Lysis SyndromeMetabolism and nutrition disorders
Other adverse events (65 terms — click to expand)

ReactionSystemSRF617 + Etrumadenant + Zi…
FatigueGeneral disorders
Decreased appetiteMetabolism and nutrition disorders
NauseaGastrointestinal disorders
InsomniaPsychiatric disorders
HypotensionVascular disorders
AnaemiaBlood and lymphatic system disorders
DiarrhoeaGastrointestinal disorders
Alanine aminotransferase increasedInvestigations
Weight decreasedInvestigations
Back painMusculoskeletal and connective tissue disorders
Abdominal distensionGastrointestinal disorders
Oral dysaesthesiaGastrointestinal disorders
Blood alkaline phosphatase increasedInvestigations
Blood creatinine increasedInvestigations
Blood lactate dehydrogenase increasedInvestigations
Lipase increasedInvestigations
HypocalcaemiaMetabolism and nutrition disorders
ArthralgiaMusculoskeletal and connective tissue disorders
CoughRespiratory, thoracic and mediastinal disorders
Chest discomfortGeneral disorders
Chest painGeneral disorders
ChillsGeneral disorders
General physical health deteriorationGeneral disorders
MalaiseGeneral disorders
Non-cardiac chest painGeneral disorders
Oedema peripheralGeneral disorders
PyrexiaGeneral disorders
ConstipationGastrointestinal disorders
DyspepsiaGastrointestinal disorders
FlatulenceGastrointestinal disorders
Gastrointestinal disorderGastrointestinal disorders
Gastrooesophageal reflux diseaseGastrointestinal disorders
Oesophageal painGastrointestinal disorders
StomatitisGastrointestinal disorders
Amylase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
International normalised ratio increasedInvestigations
Lymphocyte count increasedInvestigations
HyperglycaemiaMetabolism and nutrition disorders
HypoalbuminaemiaMetabolism and nutrition disorders

Most-reported serious reactions: Spinal cord compression, Anaemia, Acute myocardial infarction, Cardiogenic shock, Disease progression, Cytokine release syndrome, Pneumonia, Back pain.

Data from ClinicalTrials.gov NCT05177770 adverse events section.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. CD39/CD73/A2AR pathway and cancer immunotherapy.
    Xia C, Yin S, To KKW, Fu L. · · 2023 · cited 230× · PMID 36859386 · DOI 10.1186/s12943-023-01733-x
  2. ATP and Adenosine Metabolism in Cancer: Exploitation for Therapeutic Gain.
    Yegutkin GG, Boison D. · · 2022 · cited 111× · PMID 35738682 · DOI 10.1124/pharmrev.121.000528
  3. Targeting purinergic pathway to enhance radiotherapy-induced immunogenic cancer cell death.
    Bao X, Xie L. · · 2022 · cited 54× · PMID 35836249 · DOI 10.1186/s13046-022-02430-1
  4. Small-molecule agents for cancer immunotherapy.
    Wang F, Fu K, Wang Y, Pan C, et al · · 2024 · cited 41× · PMID 38486980 · DOI 10.1016/j.apsb.2023.12.010
  5. The interplay between the DNA damage response and ectonucleotidases modulates tumor response to therapy.
    Stagg J, Golden E, Wennerberg E, Demaria S. · · 2023 · cited 39× · PMID 37418547 · DOI 10.1126/sciimmunol.abq3015
  6. Targeting tumor-infiltrating tregs for improved antitumor responses.
    Qin D, Zhang Y, Shu P, Lei Y, et al · · 2024 · cited 36× · PMID 38500876 · DOI 10.3389/fimmu.2024.1325946
  7. The Immune Regulatory Role of Adenosine in the Tumor Microenvironment.
    Xing J, Zhang J, Wang J. · · 2023 · cited 34× · PMID 37834375 · DOI 10.3390/ijms241914928
  8. Inhibitors of the CD73-adenosinergic checkpoint as promising combinatory agents for conventional and advanced cancer immunotherapy.
    Kurago Z, Guo G, Shi H, Bollag RJ, et al · · 2023 · cited 30× · PMID 37435071 · DOI 10.3389/fimmu.2023.1212209

Verify or expand the search:

Other trials of SRF617

Trials testing the same drug.

Other recruiting trials for Metastatic Castration-resistant Prostate Cancer

Currently open trials in the same condition.

Other Coherus Oncology, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05177770.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing