NCT04183764Unknown1 期
A Phase Ⅰ Study for Safety, Tolerance, Pharmacokinetic Characteristic of MAX-40279-01 in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Phase II dose (RP2D)
研究概览
简要总结
This is a multi-center, non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-40279-01 in patients with advanced solid tumor.
详细描述
This is a two-part study comprised of a dose escalation part and a dose expansion part.
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
- •Males and/or females over age
- •Histologically or cytologically confirmed advanced or metastatic solid tumor for which no established standard therapy is available.
- •At least one measurable lesion by CT or MRI according to RECIST1.1, which is not in irradiated area (only for expansion phase).
- •Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (in case of alopecia, Grade 2 is acceptable).
- •Life expectancy of at least 3 months.
- •Female participants of child bearing potential agree not to be pregnant or lactating during the study and for three months following the last dose of study drug. Both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for three months following the last dose of study drug. A highly effective method of contraception is defined as one that results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly.
排除标准
- •Any anti-tumor treatment with radiation therapy, surgery, or immunotherapy wihtin 2 weeks (3 weeks for chemotherapy; 6 weeks for nitrosoureas or Mitomycin C) prior to trial entry.
- •Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
- •Previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 2 years at the trial entry.
- •Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery.
- •Laboratory values not within the Protocol-defined range.
- •Cardiac disease , including congestive heart failure, myocardial infarction, unstable arrhythmia, or symptomatic peripheral arterial vascular disease.
- •Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
- •Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- •Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial.
研究组 & 干预措施
MAX-40279-01
Experimental
capsule, 5mg and 25mg
干预措施: MAX-40279-01 (Drug)
结局指标
主要结局
Phase II dose (RP2D)
时间窗: 4 weeks
The number and proportion of patients experiencing at least 1 dose-limiting toxicity (DLT) will be used as the primary measure to evaluate the RP2D of MAX-40279-01.
Maximum tolerated dose (MTD）
时间窗: 4 weeks
MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of multiple dosing.
Adverse events (AEs)
时间窗: 8 weeks
Incidence of treatment-related AEs
次要结局
- Tmax(Approximately 4 weeks)
- Cmax(Approximately 4 weeks)
- Objective response rate (ORR)(12 months (anticipated))
研究者
研究点 (1)
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