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.
Aged >=18 years old.
Patients with metastatic castration-resistant prostate cancer who have failed standard treatments.
According to RECIST 1.1, there is at least one measurable lesion.
ECOG performance status 0-1.
Received anti-tumor therapy within 4 weeks before enrollment.
Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.
Have undergone surgery within 4 weeks before enrollment.
Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1).
Single group
177Lu-FC516
DrugThe drug was administered once every 6 weeks. It was expected that the drug would be administered for 1 to 4 cycles.
Determine dose-limiting toxicity (DLT)
Determine the DLT of FC516
Frequency of adverse events (AEs) and SAEs
To investigate the safety characteristics of FC516
Determine the Maximum Tolerated Dose (MTD)
Determine the MTD of FC516
Objective response rate (ORR)
To explore the clinical effectiveness. Tumor response based on RECIST 1.1
Progression free survival (PFS)
PFS as assessed using RECIST 1.1
Disease control rate (DCR)
DCR as assessed using RECIST 1.1
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FindCure Biosciences (ZhongShan) Co., Ltd.
Lead sponsor
Affiliated Hospital of Jiangnan University
Collaborator
