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The Safety, Dosimetry and Efficacy of 177Lu-FC516 in Patients With Prostate Cancer
Sponsor: FindCure Biosciences (ZhongShan) Co., Ltd.
Summary
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.
Official title: Evaluation of the Safety, Dosimetry and Efficacy of 177Lu-FC516 Injection in Patients With Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
13
Start Date
2026-08-31
Completion Date
2027-10
Last Updated
2026-09-04
Healthy Volunteers
No
Conditions
Interventions
177Lu-FC516
The drug was administered once every 6 weeks. It was expected that the drug would be administered for 1 to 4 cycles.
Locations (1)
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China