A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Axl Inhibitor FC084CSA in Patients With Advanced Malignant Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Determine the Maximum Tolerated Dose (MTD)
研究概览
简要总结
This is a phase I clinical study to evaluate safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of Axl inhibitor FC084CSA in patients with advanced malignant solid tumors who have failed standard anti-cancer treatment.
详细描述
FC084CSA accelerated doses at 100mg QD, and then started the conventional "3+3" design from 200mg QD.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 75 years old male and female.
- •Patients with advanced malignant solid tumors 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) ≥85 g/L, neutrophil count (ANC) ≥1.5×10^9/L, platelet count ( PLT) ≥75×10^9/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
- •Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 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, and the investigator believes that the patient's state has not recovered to the point where the study can be started.
- •Patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods.
- •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
FC084CSA
干预措施: FC084CSA tablets (Drug)
结局指标
主要结局
Determine the Maximum Tolerated Dose (MTD)
时间窗: Approximately 12 months
The highest dose is defined at which no more than 1 of 3 evaluable participants has had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria and determination by Investigator and Data and Safety Monitoring Committee.
Determine the Recommended Phase 2 Dose (RP2D)
时间窗: Approximately 12 months
The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD.
Determine dose-limiting toxicity (DLT)
时间窗: 24 days after first dose
Determine the DLT of FC084CSA
Frequency of adverse events (AEs) and SAEs
时间窗: Approximately 12 months
To investigate the safety characteristics of FC084CSA
次要结局
- Pharmacokinetic (PK) Cmax(Approximately 12 months)
- Pharmacokinetic (PK) Tmax(Approximately 12 months)
- Progression free survival (PFS)(Approximately 12 months)
- Pharmacokinetic (PK) AUC 0-t(Approximately 12 months)
- Pharmacokinetic (PK) AUC 0-∞(Approximately 12 months)
- Pharmacokinetic (PK) t1/2(Approximately 12 months)
- Objective response rate (ORR)(Approximately 12 months)
- Disease control rate (DCR)(Approximately 12 months)