A Phase I Study for Tolerance and Pharmacokinetic Characteristic of MAX-40279 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
This is a non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-40279-01 in patients with Relapsed or Refractory AML.
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
- •Subject has morphologically documented relapsed or refractoryprimary AML as defined by the World Health Organization (WHO) 2016 criteria for which no established standard therapy is available.
- •ECOG performance status of 0 to
- •Persistent chronic clinically significant non-hematological toxicities from prior treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, HSCT, or surgery) must be Grade ≤
- •Any anti-tumor treatment with radiation therapy, surgery, or immunotherapy wihtin 2 weeks prior to trial entry.
- •Life expectancy of at least 3 months.
- •Both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for six months following the last dose of study drug.
排除标准
- •Disease diagnosis of acute promyelocytic leukemia.
- •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 5 years at the trial entry.
- •Laboratory values not within the Protocol-defined range.
- •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
干预措施: MAX-40279-01 (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: 8 weeks
Incidence of treatment-related AEs
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.
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.
次要结局
- Tmax(Approximately 4 weeks)
- AUC(Approximately 4 weeks)
- t1/2(Approximately 4 weeks)
- Objective response rate (ORR)(1 months (anticipated))
- Cmax(Approximately 4 weeks)