NCT03516123已完成1 期
A Phase I, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, PK 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
- 18
- 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, dose escalation & expansion phase I study to evaluate the clinical safety, tolerability, PK, and preliminary efficacy of CS3006.
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
- •Subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
- •ECOG performance status of 0 or
- •Life expectancy ≥12 weeks.
- •Able to swallow and retain oral medication.
- •Subjects must have adequate organ function.
- •Use of effective contraception.
排除标准
- •Subjects receiving anti-cancer therapy at the time of enrollment.
- •Subjects who had prior chemotherapy, targeted therapy, immunotherapy or any other systemic anti-cancer treatment, within 14 days prior to the first dose of CS3006 or who has not recovered from adverse events due to a prior therapy.
- •Receipt of any prior therapy with a MEK inhibitor.
- •Use of any investigational anti-cancer drug within 28 days before the first dose of CS
- •Current use of a prohibited medication or use during treatment of CS
- •Current use of warfarin.
- •Any condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
- •History of retinal vein occlusion (RVO) or central serous retinopathy (CSR).
- •Visible retinal pathology as assessed by ophthalmologic exam.
- •Intraocular pressure > 21mm Hg as measured by tomography.
- •Glaucoma diagnosed within one month prior to the first dose of CS
- •Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
- •Primary malignancy of CNS.
- •Evidence of severe or uncontrolled systemic diseases.
- •Subjects with clinically significant cardiovascular disease.
- •QTc interval >= 450 msecs for male or >= 470 msecs for female
- •Known history of HIV.
- •Subjects with active Hepatitis B or C infection
- •History of immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to CS
- •For more information regarding trial participation, please contact at cstonera@cstonepharma.com
研究组 & 干预措施
CS3006
Experimental
Participants will receive CS3006 orally at specified dose on specified days
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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