A Phase 1/2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-361175 in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 入组人数
- 90
- 试验地点
- 8
- 主要终点
- Phase II: the objective response rate (ORR)
研究概览
简要总结
This is a phase I/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of BPI-361175 tablets in patients with advanced solid tumors including advanced Non-small cell Lung cancer (NSCLC).This is a three-stage study, consisting of Phase Ia dose escalation, Phase Ib dose expansion and pivotal Phase II Study. The pivotal Phase II study will be designed based on data generated from the Phase I studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Male or female ≥ 18 years old;
- •Patients with histologically or cytologically confirmed diagnosis of inoperable locally advanced or recurrent/metastatic non-small cell lung cancer (NSCLC) with EGFR sensitive mutations. Patients must have progressed from or be intolerant to or be unfit for standard treatment, or the standard treatment does not exist;
- •For dose expansion and Phase II, patients must be willing to provide tumor tissues (archived tumor tissue samples within 2 years or fresh tumor tissues) and/or blood samples for central lab testing;
- •Measurable or evaluable disease;
- •Adequate bone marrow, liver, and renal function.
排除标准
- •Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases which are not suitable for enrollment, as judged by investigators;
- •Pregnancy or lactation;
- •Other protocol specified criteria.
研究组 & 干预措施
Phase I
Patients will receive a single dose on Day 1, then after an 7-day wash-out period, repeated dosing, once daily will be initiated(Ia).
Patients receive BPI-361175 PO. Cycles repeat every 28 days(Ib).
干预措施: BPI-361175 (Drug)
Phase II
Patients receive BPI-361175 based on RP2D.
干预措施: BPI-361175 (Drug)
结局指标
主要结局
Phase II: the objective response rate (ORR)
时间窗: Through the Phase II, approximately 24 months
The proportion of patients with complete response (CR) and partial response (PR) in all patients.
Phase I: The adverse events (AEs)
时间窗: Through the Phase I, approximately 24 months
Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs).
Phase I: Determine the recommended Phase II dose (RP2D)
时间窗: Through the Phase I, approximately 24 months
Number of subjects with dose limiting toxicity
次要结局
- Phase II: Progression free survival (PFS)(Through the Phase II, approximately 24 months)
- Phase II: Duration of response (DOR)(Through the Phase II, approximately 24 months)
- Phase I: Evaluate the pharmacokinetics of BPI-361175(Through the Phase I, approximately 24 months)
- Phase II: Overall survival (OS)(Through the Phase II, approximately 24 months)
- Phase I: the objective response rate (ORR)(Through the Phase I, approximately 24 months)
- Phase II: Disease control rate (DCR)(Through the Phase II, approximately 24 months)
- Phase II: The adverse events (AEs)(Through the Phase II, approximately 24 months)
- Phase I: Disease control rate (DCR)(Through the Phase I, approximately 24 months)
- Phase I: Progression free survival (PFS)(Through the Phase I, approximately 24 months)
- Phase I: Overall survival (OS)(Through the Phase I, approximately 24 months)