Study of SRF617 With AB928 (Etrumadenent) and AB122 (Zimberelimab) in Patients With Metastatic Castration Resistant Prostate Cancer
SRF617-201 (primary)
NCI-2022-02287
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).
Objectives
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).
Eligibility
- = 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.
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.