NCT05756153已完成1 期
A Phase Ib/II, Multi-Center, Open-Label Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 20
- 主要终点
- Phase Ib: adverse events
研究概览
简要总结
This is a Phase Ib/II study. The objectives are to evaluate the safety/tolerability and efficacy of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC, to characterize pharmacokinetics (PK) of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC
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
- •Patient has provided informed consent form (ICF).
- •Males or females aged ≥ 18 years.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~
- •Life expectancy > 3 months judged by the investigator.
- •Have histologically or cytologically confirmed advanced KRAS G12C-mutated NSCLC.
- •Have at least one measurable lesion per RECIST 1.
- •Have sufficient organ functions.
- •With toxicities left from prior anti-tumor therapy resolved to baseline or CTCAE Grade 1 (neurotoxicity or alopecia ≤ Grade 2).
- •Women of childbearing potential (WOCBP) and male patients with WOCBP partners must agree to use effective contraception method during the study specified period.
排除标准
- •With clinically significant cardiovascular diseases.
- •With active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •With clinically significant gastrointestinal diseases.
- •With active infections.
- •With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.
- •With uncontrolled systemic diseases, such as hypertension or diabetes.
- •Prior treatment with an inhibitor specific to KRAS G12C.
- •Major surgery within 4 weeks prior to initiation of study treatment.
- •With known allergies to the study drugs or components.
- •Pregnant or lactating females, or female patients intend to become pregnant during participation.
研究组 & 干预措施
GFH925+Cetuximab
Experimental
干预措施: GFH925 (Drug)
GFH925+Cetuximab
Experimental
干预措施: Cetuximab (Drug)
结局指标
主要结局
Phase Ib: adverse events
时间窗: 28 days
defined as number of patients with treatment emergent AEs
Phase II: objective response rate
时间窗: up to 1 year after last patient in
defined as the percent of patients documented a PR/CR
次要结局
未报告次要终点
研究者
研究点 (20)
Loading locations...
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