NCT07026916撤回2 期
A Single-Arm, Multicenter, Open-Label, Phase II Clinical Study to Evaluate the Efficacy, Safety/Tolerability, and Pharmacokinetic Characteristics of GFH375 Monotherapy in Patients With Previously Treated KRAS G12D Mutant Metastatic Pancreatic Cancer
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 83
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This is a multicenter, open-label, phase II study to explore the efficacy, safety/tolerability and pharmacokinetics (PK) of GFH375 in in Patients with Previously Treated KRAS G12D Mutant Metastatic Pancreatic Cancer.
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.
- •With histologically or cytologically confirmed metastatic pancreatic cancer harboring KRAS G12D mutation
- •Be able to provide tumor tissue samples that meet the requirements
- •Have at least one measurable lesion according to RECIST1.1
- •ECOG performance status of 0-
- •With a life expectancy of ≥12 weeks.
- •Adequate laboratory parameters during the screening period.
排除标准
- •Active brain metastases.
- •Prior treatment with a KRAS G12D inhibitor or a pan-RAS/KRAS inhibitor.
- •With 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
Overall response rate (ORR)
时间窗: 24 months
ORR assessed by Blinded Independent Central Review
次要结局
- DCR(24 months)
- DoR(24 months)
- TTR(24 months)
- PFS(24 months)
- The incidence and severity of AEs and SAEs(24 months)
- Plasma concentrations of GFH375(6 months)
- ORR(24 months)
研究者
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