A Phase I Study With Single/Multiple Dose Administered to Explore the Safety/Tolerability and Pharmacokinetics of GFH018 in the Treatment of Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of Dose-limiting Toxicity (DLT) Events
研究概览
简要总结
This is the first- in human study of GFH018 comprised of a dose escalation part and a dose expansion part in subjects with advanced solid tumors after single/multiple administration. The study is designed to explore the safety/tolerability, pharmacokinetics, and MTD of GFH018 and to define a RP2D of GFH018.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Eligible subjects must meet all the inclusion criteria listed below:
- •Voluntarily participate in this clinical trial and are willing to sign informed consent forms.
- •Male or female aged from 18-75 years old (inclusive).
- •Diagnosed with histologically or cytologically confirmed advanced solid tumors.
- •Evaluable lesions defined by RECIST v1.
- •Eastern Cooperative Oncology Group performance status of 0 to
- •Subjects or their legal representatives are able to communicate well with Investigators and are willing to comply with the protocol and complete the study.
排除标准
- •Eligible subjects should not meet any of the exclusion criteria listed below:
- •With clinically significant cardiac diseases.
- •With clinically significant digestive disorders.
- •Other severe disease.
- •Pregnant or lactating women.
- •Other unfavorable situations for subjects to participate in the study judged by Investigators.
研究组 & 干预措施
Dose escalation Cohort 1
5 mg BID, 14d-on/14d-off
干预措施: GFH018 (Drug)
Dose escalation Cohort 2
10 mg BID, 14d-on/14d-off
干预措施: GFH018 (Drug)
Dose escalation Cohort 3
20 mg BID, 14d-on/14d-off
干预措施: GFH018 (Drug)
Dose escalation Cohort 4
30 mg BID, 14d-on/14d-off
干预措施: GFH018 (Drug)
Dose escalation Cohort 5
40 mg BID, 14d-on/14d-off
干预措施: GFH018 (Drug)
Dose escalation Cohort 6
50 mg BID, 14d-on/14d-off
干预措施: GFH018 (Drug)
Dose escalation Cohort 7
65 mg BID, 14d-on/14d-off
干预措施: GFH018 (Drug)
Dose escalation Cohort 8
85 mg BID, 14d-on/14d-off
干预措施: GFH018 (Drug)
Dose escalation Cohort 9
85 mg BID, 7d-on/7d-off
干预措施: GFH018 (Drug)
Dose expansion Cohort 10
85 mg BID, 14d-on/14d-off
干预措施: GFH018 (Drug)
结局指标
主要结局
Incidence of Dose-limiting Toxicity (DLT) Events
时间窗: 31 days after the first dose
次要结局
未报告次要终点