Testing 177Lu-FC516, a radioactive drug, in people with prostate cancer
Tests 177Lu-FC516 for safety and effect in adults with prostate cancer.
Plain-language title generated from the registry record
Registry title: The Safety, Dosimetry and Efficacy of 177Lu-FC516 in Patients With Prostate Cancer
Key facts
- Where
- Wuxi, ChinaSee the site
- Phase
- Early phase 1
Where in China
- Affiliated Hospital of Jiangnan UniversityWuxi, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- FindCure Biosciences (ZhongShan) Co., Ltd.
- Trial code
- NCT07542379
- Record updated
- 4 September 2026
- Original description
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.Read full original descriptionShow less
Evaluation of the Safety, Dosimetry and Efficacy of 177Lu-FC516 Injection 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.
Inclusion: 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; Laboratory examination should meet: ① Blood routine: hemoglobin (HGB) ≥90g/L, neutrophil count (ANC) ≥1.5×10\^9/L, platelet count ( PLT) ≥100×10\^9/L; ②Blood biochemistry: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0×ULN, serum creatinine ( Cr)≤1.5×ULN or calculate the creatinine clearance ≥50 mL/min according to the Cockcroft-Gault formula method.
Exclusion: 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); Central nervous system metastases with clinical symptoms; With any situations that the researcher considers inappropriate to participate in this research.