Evaluation of the Safety, Dosimetry and Efficacy of 177Lu-FC516 Injection in Patients With Prostate Cancer
概览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- FindCure Biosciences (ZhongShan) Co., Ltd.
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Determine dose-limiting toxicity (DLT)
概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
177Lu-FC516 injection
干预措施: 177Lu-FC516 (Drug)
结局指标
主要结局
Determine dose-limiting toxicity (DLT)
时间窗: 42 days after first dose
Determine the DLT of FC516
Frequency of adverse events (AEs) and SAEs
时间窗: Approximately 12 months
To investigate the safety characteristics of FC516
Determine the Maximum Tolerated Dose (MTD)
时间窗: Approximately 12 months
Determine the MTD of FC516
次要结局
- Objective response rate (ORR)(Approximately 12 months)
- Progression free survival (PFS)(Approximately 12 months)
- Disease control rate (DCR)(Approximately 12 months)