An Open-label, Multicenter Phase 1/2 Study to Evaluate the Safety and Efficacy of AB-3028 in Patients With Castration Resistant Prostate Cancer (CRPC)
Condition: Metastatic Castration Resistant Prostate Cancer (mCRPC)
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT07285694
Sponsor: Arsenal Biosciences, Inc.
Phase: Phase 1/Phase 2
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: Male
Key Inclusion Criteria:
- 1. At least 18 years of age at time of signing informed consent form. 2. Histologically confirmed adenocarcinoma of the prostate, meeting all of the following criteria: • Documented progressive metastatic castration-resistant prostate cancer (mCRPC) based on PCWG3 criteria. 3. Prior prostate cancer treatment with at least 1 novel androgen receptor pathway inhibitor (ARPI) therapy. • PSMA+ by PSMA PET.
- Measurable disease by RECIST 1.1 criteria, or evaluable disease via measurable PSA (≥ 1 ng/mL) per PCWG3 criteria. 4. Adequate organ functions.
Key Exclusion Criteria:
- Any prior systemic therapy for CRPC within 14 days prior to scheduled protocol required leukapheresis.
- Central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression.
- Unwillingness to participate in an extended safety monitoring period.
View trial on ClinicalTrials.gov