The Safety, Dosimetry and Efficacy of 177Lu-FC516 in Patients With Prostate Cancer

This study is a prospective, single-arm, open-label, dose-escalation study. A total of 5 dose groups were pre-defined in this study. The drug was administered once every 6 weeks.The drug would be administered for 1 to 4 cycles. After each dose group completed the enrollment and DLT observation, based on the participant's safety tolerance, radiation dosimetry, and preliminary efficacy evaluation results, it was decided whether to adjust the dose of the subsequent dose groups or to suspend the dose escalation.

NCT Number	NCT07542379
Lead Sponsor	FindCure Biosciences (ZhongShan) Co., Ltd. Collaborators: Affiliated Hospital of Jiangnan University
Conditions	Prostate Cancer
Enrollment	13 participants
Start Date	2026-04
Primary Completion	2027-05 (estimated)
Study Completion	2027-10 (estimated)
Updated on ClinicalTrials.gov	2026-04-21