About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- 177Lu-FC516
Treatment groups
Sponsors and collaborators
FindCure Biosciences (ZhongShan) Co., Ltd.
Lead sponsor
Affiliated Hospital of Jiangnan University
Collaborator