NCT00555724已完成1 期
A Phase 1, Open Label, Dose Escalation Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Subjects With Relapsed or Refractory 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
- 发起方
- Biogen
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of BIIB022
研究概览
简要总结
Phase 1, open-labeled, dose escalation safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.
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
- •Age 18 years or older at the time of informed consent
- •Relapsed or refractory solid tumors following standard therapy.
- •ECOG Performance Status 0 or 1.
排除标准
- •History of insulin-dependent diabetes, type 2 diabetes, or hemoglobin A1c >6% at screening.
- •History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.
- •Known central nervous system or brain metastases.
- •Prior anti-IGF-1R therapy of any kind.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
BIIB022
Experimental
干预措施: BIIB022 (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of BIIB022
时间窗: ongoing
次要结局
- To evaluate pharmacokinetics(ongoing)
研究者
研究点 (1)
Loading locations...
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