A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-21668 in Advanced Solid Tumor Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Determine the Maximum Tolerated Dose (MTD)
研究概览
简要总结
This study is an open-label, single arm, dose escalation and dose expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BPI-21668 in solid tumor patients. In dose escalation phase, biomarker status is not required, but in dose expansion phase patients are required to harbor PIK3CA mutation.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤70 years, male and female patients;
- •Life expectancy ≥ 12 weeks;
- •ECOG performance score 0-1;
- •Locally advanced or relapsed/metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy or for whom no standard therapy exists, PIK3CA mutation status is required for dose expansion phase;
- •Evaluable lesion required for dose escalation phase and measurable lesion as per RECIST 1.1 required for dose expansion phase;
- •Adequate organ function;
- •Signed informed consent.
排除标准
- •Prior use of PI3K、mTOR or AKT inhibitor;
- •Prior other malignant tumor;
- •Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases ;
- •Type I or type II diabetes;
- •Inadequate wash-out of prior anti-cancer therapies;
- •Cardiac disorders;
- •Instable systemic diseases;
- •Acute or chronic pancreatitis;
- •Pregnancy or lactation;
- •Other protocol specified criteria.
研究组 & 干预措施
Dose Escalation
Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 28 days in duration with BPI-21668 administered, once daily (QD).
干预措施: BPI-21668 (Drug)
Dose Expansion
Oral tablets administered at MTD/RP2D. Each treatment cycle will be 28 days in duration with BPI-21668 administered, once daily (QD).
干预措施: BPI-21668 (Drug)
结局指标
主要结局
Determine the Maximum Tolerated Dose (MTD)
时间窗: Through the Phase I, approximately 24 months
The MTD will be based on DLT.
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).
Determine the recommended Phase II dose (RP2D)
时间窗: Through the Phase I, approximately 24 months
The RP2D will be based on DLT.
次要结局
- Determination of anti-tumor activity of BPI-21668(Through the Phase I, approximately 24 months)
- Evaluate the pharmacokinetics of BPI-21668(Through the Phase I, approximately 24 months)