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:

  1. Any prior systemic therapy for CRPC within 14 days prior to scheduled protocol required leukapheresis.
  2. Central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression.
  3. Unwillingness to participate in an extended safety monitoring period.

View trial on ClinicalTrials.gov