NCT05010694进行中（未招募）1 期
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of GH35 Tablets in Patients Harboring With G12C Mutation in Advanced Solid Tumors
Suzhou Genhouse Bio Co., Ltd.2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年9月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Dose-limiting toxicities (DLT)
研究概览
简要总结
Evaluate the safety and tolerability of GH35 in patients with KRAS mutant advanced solid tumors.
Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in patients with KRAS mutant 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects greater than or equal to 18 years old.
- •Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor with KRAS mutation identified.
- •Expected survival time ≥12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Must have at least one measureable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.
- •Have documented disease progression or intolerance after first-line treatment.
排除标准
- •Gastrointestinal (GI) tract disease causing the inability to take oral medication.
- •Previous accept with KRAS G12C inhibitor.
- •Uncontrollable general infection.
- •Serious cardiovascular disease.
- •Left ventricular ejection fraction (LVEF) <50 %.
- •Known history of hypersensitivity to any of the excipients of GH35 tablets
- •Pregnant or nursing (lactating) women.
研究组 & 干预措施
Monotherapy Dose Escalation.
Experimental
Treatment with GH35 alone, conducted until disease progression, intolerance or end of study.
干预措施: GH35 Tablet (Drug)
结局指标
主要结局
Dose-limiting toxicities (DLT)
时间窗: 24 Days
Number of participants with dose limiting toxicities (DLTs)
次要结局
- Objective response rate (ORR) as defined by RECIST 1.1 criteria(30 Months)
- Duration of response (DOR) as defined by RECIST 1.1 criteria(30 Months)
- Progression-free survival (PFS) as defined by RECIST 1.1 criteria(30 Months)
- Characterize the safety of GH35 in subjects(30 Months)
- Pharmacokinetics of GH35(1 Month)
- Disease control rate (DCR) as defined by RECIST 1.1 criteria(30 Months)
研究者
研究点 (2)
Loading locations...
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