A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Recombinant Human Interleukin-21 (rIL-21) in Subjects With Metastatic Melanoma or Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- ZymoGenetics
- 入组人数
- 43
- 试验地点
- 4
- 主要终点
- To determine the maximum tolerated dose (MTD) of rIL-21
研究概览
简要总结
This study is being done to see if an experimental drug called recombinant interleukin-21 (rIL-21) when given to patients with stage 4 malignant melanoma or stage 4 kidney cancer is safe and has any effect on these types of cancers.
详细描述
This is a phase 1 safety study. Everyone enrolled and eligible will be given rIL-21. The study has 2 parts, Part A will determine how high a dose of rIl-21 can be safely given to patients with these types of cancers. Part B will determine if the drug is of any benefit to patients with these types of cancers. Part A may have up to 7 different dose groups. Beginning with the lowest dose, 3 patients will be treated and will be watched for side effects. If the side effects are not severe, the next group of 3 patients will recieve a higher dose. This cycle is repeated until the highest tolerated dose group is found.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •18 years and older with stage 4 metastatic malignant melanoma or stage 4 metastatic kidney cancer
- •ECOG status of 0 or 1
- •Patients must have adequate liver, kidney and bone marrow function
排除标准
- •Known ocular melanoma
- •Suspected or confirmed brain metastases
- •Patient cannot have had a bone marrow transplant
结局指标
主要结局
To determine the maximum tolerated dose (MTD) of rIL-21
To further characterize the safety of rIL-21 at the MTD
次要结局
- Characterize pharmacokinetics of rIL-21
- Evaluate immunogenicity of rIL-21
- Identify clinical or biological parameters that may correlate with clinical efficacy
- Characterize anti-tumor effect of IL-21