A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Phase Ia:The incidence and severity of AEs and SAEs
研究概览
简要总结
This study is an investigation to evaluate the safety/tolerability, pharmacokinetics (PK), and efficacy of GFH276 as a single agent in patients with advanced solid tumors harboring RAS mutations.
The primary objectives of the Phase I study are to assess the safety/tolerability, PK, and preliminary efficacy of GFH276 in patients with advanced solid tumors harboring RAS mutations, and to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of GFH276.
The primary objective of the Phase II study is to evaluate the efficacy of GFH276 in patients with RAS-mutant advanced pancreatic ductal adenocarcinoma (PDAC), advanced non-small cell lung cancer (NSCLC), advanced colorectal cancer (CRC), and other advanced solid tumors.
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
- •Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
- •Male or female ≥ 18 years old and ≤75 years old.
- •ECOG performance status of 0-
- •With a life expectancy of ≥3 moths
- •Have at least one measurable lesion according to RECIST1.1, and the phase Ia allows no measurable lesion.
- •Adequate laboratory parameters during the screening period.
排除标准
- •Active brain metastases.
- •Prior treatment with a PAN-RAS inhibitor.
- •Palliative radiotherapy was completed within 14 days before the first dose.
- •Have poorly controlled or severe cardiovascular disease.
- •Subjects with active hepatitis B or active hepatitis C.
- •Known allergy to the study drug or its components.
- •Pregnant or lactating women.
研究组 & 干预措施
GFH276
GFH276 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
干预措施: GFH276 (Drug)
结局指标
主要结局
Phase Ia:The incidence and severity of AEs and SAEs
时间窗: 48 months
The incidence and severity of AEs and SAEs
Phase Ia:The incidence of DLT events
时间窗: 21 days
The incidence of DLT events
Phase Ib:The incidence and severity of AEs and SAEs
时间窗: 48 months
The incidence and severity of AEs and SAEs
Phase II:Overall response rate (ORR)
时间窗: about 48 months
Aassessed by investigators according to RECIST 1.1
Efficacy endpoints
时间窗: about 48 months
Duration of response (DoR)
次要结局
- Peak Plasma Concentration(Cmax)(about 48 months)
- DCR(about 48 months)