Education and Training
Study of SRF617 With AB928 (Etrumadenent) 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).
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: SRF617
- drug: etrumadenant
- drug: zimberelimab
Eligibility
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).
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
Male
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Laith Fakhoury
+1 650-736-1252
Not Recruiting