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)
Arsenal Biosciences, Inc.
Summary
This is a multi-center, open-label Phase 1/2 trial evaluating the safety and efficacy of AB-3028 in subjects with metastatic castration resistant prostate cancer (mCRPC).
Description
This study is intended for subjects diagnosed with metastatic castration-resistant prostate cancer (mCRPC) and whose disease progressed after treatment with an androgen receptor pathway inhibitor (ARPI). The purpose of this study is to test the safety and efficacy of AB-3028 cells in subjects with metastatic castration-resistant prostate cancer. This treatment has not been approved by the Food and Drug Administration. The goal of the Phase I portion of this study is to evaluate safety profile of AB-3028 and to determine the maximum tolerated dose or recommended phase 2 dose of AB-3028. The Ph…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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 Exclusio…
Interventions
- BiologicalAB-3028
autologous T cell therapy
Locations (6)
- City of HopeDuarte, California
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- University of California, San FranciscoSan Francisco, California
- University of Iowa and Holden Comprehensive Cancer CenterIowa City, Iowa
- University of MinnesotaMinneapolis, Minnesota
- Perlmutter Cancer Center - NYU Langone HealthNew York, New York