A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- DLT
研究概览
简要总结
Evaluate the safety and tolerability of BPI-572270 in adult patients with specific RAS mutant advanced solid tumors.
详细描述
This is a Phase 1/2, multicenter open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of BPI-572270 in adult patients with advanced solid tumors harboring specific RAS mutations, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose [RP2D] within investigated patient population groups, and to further expand the enrollment of more patients to evaluate the efficacy endpoints (ORR/DCR/DOR/TTR).
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
- •Histologically confirmed advanced solid tumor with RAS mutations identified through deoxyribonucleic acid (DNA) sequencing.
- •Have received prior standard therapy appropriate for tumor type and stage.
- •Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate organ function.
排除标准
- •Primary central nervous system (CNS) tumors active and untreated brain metastases.
- •Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication.
- •History of any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy
研究组 & 干预措施
Study BPI-572270 in adults with specific RAS mutant advanced solid tumors
Capsules; Administer once a day on an empty stomach.
干预措施: BPI-572270 (Drug)
结局指标
主要结局
DLT
时间窗: up to 2 tears
Number of Participants with Dose-Limiting Toxicity (DLT)AEs, including incidence and severity of findings in laboratory values and vital signs
RP2D
时间窗: up to 2 tears
Determination of RP2D in the expansion phase
ORR
时间窗: up to 3 tears
Further expand the inclusion to clarify the efficacy endpoint ORR
次要结局
- Cmax(up to 15 weeks)
- AUC(up to 15 weeks)
- Disease Control Rate (DCR)(up to 3 years)