NCT03736850已完成1 期
A Phase I, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of the MEK Inhibitor CS3006 in Subjects With Locally Advanced or Metastatic Solid Tumors
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
- 17
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
This is a multicenter, open label, sequential-cohort, dose escalation & expansion phase I study to evaluate the clinical safety, tolerability, PK, and preliminary efficacy of CS3006 and to establish the Maximum Tolerated Dose (MTD）, if any, Recommended Phase II Doses (RP2Ds) and regimen of CS3006. The study is composed of two parts: Part 1 for dose escalation and Part 2 for dose expansion.
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
- •Willing and able to provide written informed consent for the trial.
- •Subjects must have a histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy ≥ 12 weeks.
- •Able to swallow and retain oral medication.
- •Subject must have adequate organ function.
- •Use of effective contraception.
排除标准
- •Subjects receiving cancer therapy at the time of enrollment.
- •Has had prior chemotherapy, targeted therapy, immunotherapy or any other agents used as systemic treatment for cancer, within 14 days of the first dose of investigational product administration or who has not recovered from adverse events due to a previously administered agent.
- •Previous treatment with a MEK inhibitor.
- •Use of any investigational anti-cancer drug within 28 days before the first investigational product administration.
- •Current use of a prohibited medication.
- •Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
- •Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
- •Primary malignancy of the central nervous system.
- •Evidence of severe or uncontrolled systemic diseases.
- •Subjects with clinically significant cardiovascular disease.
- •Human Immunodeficiency Virus (HIV) infection.
- •Subjects with active Hepatitis B or C infection.
- •Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product or excipients.
- •Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.
- •Unwillingness or inability to follow the procedures outlined in the protocol.
- •For more information regarding trial participation, please contact at cstonera@cstonepharma.com
研究组 & 干预措施
CS3006
Experimental
干预措施: CS3006 (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: From the day of first dose to 30 days after last dose of CS3006
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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