Clinical Trials | A Phase 1b, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Intravenous Administration of a B7-H3 Radiopharmaceutical ([225Ac]Ac-AKY-2519) in Metastatic Castration-Resistant Prostate Cancer

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with a Metastatic Castration Resistant Prostate Cancer (mCRPC) for a research study. The purpose of the study is to evaluate the safety and effects of the study drugs [225Ac]Ac-AKY-2519 and [64Cu]Cu-AKY-2519 in people with cancer. The study will also use imaging to see if the drugs reach the tumors, how the body handles them, and whether they can help control cancer growth. The study team is also looking at what happens to your tumors when a targeted radiopharmaceutical [225Ac]Ac AKY 2519 is given before or after prior study treatment with 177Lu PSMA-617 (PLUVICTO™; a different targeted radiopharmaceutical drug). In this research study, all participants will receive [64Cu]Cu AKY 2519 and [225Ac]Ac AKY 2519. This Phase 1b study consists of a dose escalation portion and a backfill portion. The dose escalation portion will investigate ascending doses of [225Ac]Ac-AKY-2519 across two cohorts enrolling in parallel: • Cohort A: participants with metastatic castration-resistant prostate cancer (mCRPC) with NO prior exposure to 177Lu-PSMA-617 (PLUVICTO™) and • Cohort B: participants with metastatic castration-resistant prostate cancer (mCRPC) with prior exposure to 177Lu-PSMA-617 (PLUVICTO™) There will be about 26 to 30 visits over 5 years which includes 12 to 16 visits in the first 6 months, 4 visits a year for the next 2 years and 2 visits a year for the next 3 years afterwards. During the study, you will take part in different tests and procedures. Additional information found here: https://clinicaltrials.gov/study/ NCT07581184 For questions, contact: https://clinicaltrials.gov/study/NCT07581184