A Phase I, Open-label, Dose-escalation Study to Determine the Maximum Tolerance Dose (MTD) and to Evaluate the Safety of 188Re-BMEDA-liposome in Patient With Primary Solid Tumor in Advanced or Metastatic Stage.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Determine the MTD
研究概览
简要总结
This is a study to determine the maximum tolerance dose (MTD) and to evaluate the safety of 188Re-BMEDA-liposome in patient with primary solid tumor in advanced or metastatic stage.
详细描述
Rhenium-188 is an ideal radionuclide for therapeutic use due to its maximum beta emission of 2.12MeV, short physical half-life of 16.9 hours, and its 155-keV gamma emission for imaging purposes. 188Re-BMEDA-liposome consists of 2 separate components (Rhenium-188 and liposome) and BMEDA as a linker. This study aims to find the MTD, evaluate the safety, efficacy profiles and investigate the biodistribution, radioactivity and radiation dosimetry of 188Re-BMEDA-liposome on primary solid tumor in metastatic stage patient by a single intravenous injection course.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with histologically confirmed diagnosis of primary solid tumor, and with pathologically or radiologically documented metastases
- •Disease that is measurable or evaluable by RECIST 1.1 criteria (for Solid Tumors)
- •Patient with metastatic cancer that are refractory to current standard/available therapies
排除标准
- •brain metastases
- •serious concurrent infection or nonmalignant illness that is uncontrolled
- •uncontrolled intercurrent illness
- •Immunocompromised
- •significant traumatic injury within 3 weeks before Day 0
- •History of hypersensitivity to any component of study drug
结局指标
主要结局
Determine the MTD
时间窗: up to 30 days per cohort
The design will use cohort of 3 patients. If none of the first 3 patients experience DLT, then dose escalation will proceed for the next dose level of patients unless the present dose level is level 6 (1.47±0.15 mCi/kg).
次要结局
- Serious Adverse event(s)(from day 0 to up t0 60 days per cohort)
- change in vital signs and pysical examination(from day 0 to up t0 60 days per cohort)
- Change in EKG(in 24hrs)
- change in lab data(from day 0 to up t0 60 days per cohort)
- Adverse event(s)(from day 0 to up t0 60 days per cohort)