NCT00674947已完成1 期
A Phase I Study of BIIB015, a Humanized, IgG1, DM4-Conjugated, Anti-Cripto, Monoclonal Antibody, for the Treatment of Subjects With Relapsed or Refractory Solid Tumors
适应症
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
- 55
- 试验地点
- 3
- 主要终点
- To evaluate safety
研究概览
简要总结
Phase 1, open-labeled, 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.
- •Solid tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists.
- •ECOG Performance Status </= 2.
排除标准
- •History of keratoconjunctivitis, open or closed angle glaucoma, or "dry eye" disease.
- •New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- •History of myocardial infarction within 6 months prior to Day
- •Presence of >/= Grade 2 peripheral neuropathy.
- •Known presence of central nervous system or brain metastases.
- •Prior therapy with a conjugated or unconjugated maytansine derivative.
结局指标
主要结局
To evaluate safety
时间窗: ongoing
To determine the maximum-tolerated dose (MTD)
时间窗: ongoing
次要结局
- To evaluate clinical activity(ongoing)
- To evaluate pharmacokinetics (PK)(ongoing)
研究者
研究点 (3)
Loading locations...
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