Clinical Trials | AMG20230239: A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator’s Choice in Participants with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over in people with prostate cancer that has spread to other parts of the body but has not yet been treated with chemotherapy (also known as chemotherapy naïve Metastatic Castration Resistant Prostate Cancer [mCRPC]) for a research study. The purpose of the study is to learn more about how tolerable and effective the investigational drug xaluritamig is when given in combination with abiraterone acetate compared to standard care Study involves 2 arms and the arm you are assigned to will be determined randomly by computer software, an important part of the study design that helps to reduce bias. You have an equal chance of being in one of the study groups. Investigational Arm - xaluritamig in combination with abiraterone acetate: If you are in this group, you will receive xaluritamig by intravenous (IV) infusion (through a tube placed into a vein usually in arm) once a week for the first month. Each infusion takes about an hour. The dose increases gradually over 4 weeks to reach the 1.5 mg target dose. After that, you will receive 1.5 mg of xaluritamig every 2 weeks. In addition to xaluritamig, you will also receive abiraterone acetate 1000 mg by mouth, once daily, starting from cycle 1 day 1. Control Arm - abiraterone, docetaxel or cabazitaxel: If you are in this group, you will decide with your study doctor whether to receive abiraterone acetate (1000 mg) by mouth, once daily, IV docetaxel (75 mg/m2) every 3 weeks, or IV cabazitaxel (20 or 25 mg/m2) every 3 weeks. The total study duration is expected to be approximately 82 months from the first participant randomized with an enrollment duration of approximately 22 months and 60 months treatment and follow-up. This study will consist of a 28-day screening period, a treatment period, a SFU period, and a LTFU period. For questions, contact: [email protected]