A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS02 in Participants With EGFR Mutation-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 294
- 试验地点
- 5
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
This is a first-in-human (FIH) Phase I/II, multi-center, open-label, study of ANS02, in patients with advanced NSCLC. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS02 as monotherapy.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- •Life expectancy ≥ 12 weeks
- •Measurable disease per RECIST v1.1
- •Adequate organ and marrow function as defined in the protocol
- •With documentation of EGFR alteration
排除标准
- •Active infection including tuberculosis and HBV, HCV or HIV
- •Known active or untreated CNS metastases
- •Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression
- •Participants with serious cardiovascular or cerebrovascular diseases
研究组 & 干预措施
ANS02
ANS02 capsules, oral administration
干预措施: ANS02 (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: From the time of first dose to 28 days post last dose of ANS02
Number of patients with adverse events by system organ class and preferred term
Incidence of Serious Adverse Events (SAEs)
时间窗: From time of first dose to 28 days post last dose of ANS02
Number of patients with serious adverse events by system organ class and preferred term
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
时间窗: From time of first dose of ANS02 to end of DLT period (approximately 28 days)
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Incidence of baseline laboratory finding, ECG and vital signs changes
时间窗: From time of first dose to 28 days post last dose of ANS02
Measured by laboratory and vital sign variables over time including change from baseline
次要结局
- Pharmacokinetics of ANS02: Plasma PK concentrations(From date of first dose of ANS02 up until 7 days post last dose)
- Pharmacokinetics of ANS02: Area under the concentration time curve (AUC)(From date of first dose of ANS2 up until 7 days post last dose)
- Pharmacokinetics of ANS02: Maximum plasma concentration of the study drug (C-max)(From date of first dose up until 7 days post last dose)
- Pharmacokinetics of ANS02: Time to maximum plasma concentration of the study drug (T-max)(From date of first dose up until 7 days post last dose)
- Pharmacokinetics of ANS02: Clearance(From date of first dose up until 7 days post last dose)
- Pharmacokinetics of ANS02: Half-life(From date of first dose up until 7 days post last dose)
- Proportion of patients with radiological response (ORR)(From date of first dose of ANS02 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years))
- Duration of Response (DoR)(From date of first dose of ANS02 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years))
- Disease Control Rate (DCR)(From date of first dose of ANS02 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years))
- Progression free Survival (PFS)(From date of first dose of ANS02 up until date of progression or death due to any cause (approximately 2 years)])
- Overall Survival (OS)(From date of first dose of ANS02 up until the date of death due to any cause (approximately 2 years))