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Study of SRF617 With AB928 (Etrumadenent) and AB122 (Zimberelimab) in Patients With Metastatic Castration Resistant Prostate Cancer
Trial ID: NCT05177770
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).
A Phase 2 Trial of SRF617 in Combination With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration-Resistant Prostate Cancer
- ≥ 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
- 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
- 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
- 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
- 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
- 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
- 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
• 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
• 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).
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