Clinical Trials | A Phase 2 Dose Optimization Trial Evaluating a CD46-Targeted Antibody-Drug Conjugate (FG-3246) in Patients with Metastatic Castration-Resistant Prostate Cancer

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with Metastatic Castration-Resistant Prostate Cancer (mCRPC) which has progressed after treatment with one prior second-generation androgen receptor signaling inhibitor (ARSI) drug, a type of drug that blocks androgens, the hormone that drives growth of the prostate cancer, and are in need of additional treatment. The purpose of this study is to find the best dose for study drug FG-3246, an antibody drug conjugate, based on safety and ability of the study drug to shrink your tumor and delay progression of disease, in men with metastatic castration-resistant prostate cancer. In this study, you will be randomized to 1 of 3 study arms (each arm receives the same study drug but at different doses) in the study. All arms involve you receiving intra-venous (IV, directly into a vein) infusions of Study Drug every 3 weeks. Your study doctor will inform you which dose you will receive. You may continue receiving the Study Drug as long as you and your study doctor see potential benefit and you are tolerating the study drug. You may or may not benefit as a result of your participation in this study. However, this study may also help doctors learn things that can help other people in the future. You are expected to be in the study for a minimum of 65 weeks, which includes 6 weeks of screening, one cycle of study drug FG-3246 (3 weeks), 4 weeks for an End of Study Treatment visit, and 52 weeks of long-term follow-up. The amount of time you are in the study will depend on how many cycles of study drug FG-3246 you are given. Additional information found here: [clinical trials link-TBD] For questions, contact: [email protected]