NCT06500676招募中1 期
An Open-Label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GFH375 in Patients With KRAS G12D Mutant Advanced Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 407
- 试验地点
- 20
- 主要终点
- Phase Ia:The incidence and severity of AEs and SAEs
研究概览
简要总结
This is a multicenter, open-label, phase I/II study to explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GFH375 in patients with advanced solid tumors harboring a KRAS G12D mutation.
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 ≥12 weeks.
- •With histologically or cytologically confirmed advanced or metastatic solid tumors harboring KRAS G12D mutation.
- •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 KRAS G12D 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
GFH375
Experimental
干预措施: GFH375 (Drug)
结局指标
主要结局
Phase Ia:The incidence and severity of AEs and SAEs
时间窗: 24 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: 24 months
The incidence and severity of AEs and SAEs
Phase II:Overall response rate (ORR)
时间窗: 24 months
For NSCLC cohort： Assessed by BICR according to RECIST 1.1；For other cohorts： Assessed by investigators according to RECIST 1.1；
次要结局
- Plasma concentrations(up to 21 days)
- Efficacy endpoints(24 months)
研究者
研究点 (20)
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