We are doing this study to find the most effective, safe dose of an experimental drug called FG-3246 (the study drug) that is being developed for people with metastatic castration-resistant prostate cancer. We want to know if it is able to shrink the size of tumors and delay the progression of the disease.

Metastatic Castration-Resistant Prostate Cancer

Adults ages 18+ who:

• Are diagnosed with prostate adenocarcinoma
• Have serum testosterone levels 50 ng/dL
• Have had their disease progress on one previous treatment with a second-generation ARSI (abiraterone acetate, enzalutamide, apalutamide, or darolutamide)
• Have never had previous treatment with a therapeutic targeting CD46

For more information, contact the study team at julia.hurrelbrink@duke.edu.

If you choose to join this study, you will get a random assignment (by chance) to 1 of 3 different groups. Depending on your assignment, you will either:

• Get a lower dose of the study drug; OR
• Get a medium dose of the study drug; OR
• Get a higher dose of the study drug

The study drug is given as an intravenous (IV) infusion into a vein in your arm. You will get your assigned dose of the study drug once every 21 days. The number of doses of the study drug that you get will depend on how your body responds to the drug (i.e., until the study doctor decides that you are no longer receiving a positive benefit or it is no longer necessary to take the drug).