NCT00105170终止1 期
A Phase I, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of hCBE-11, a Humanized Monoclonal Antibody, in Subjects With Advanced Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors
研究概览
简要总结
This is a Phase I, open-label, dose-escalation study on subjects with advanced solid tumors. This is the first study of hCBE-11 in humans and is designed to determine the safety and how well patients tolerate this investigational drug. The study duration is two years with treatment visits occurring weekly for either 4 or 8 weeks, follow-up for 8 weeks and long-term follow-up contact every 3 months thereafter.
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
- •Relapsed or refractory solid tumors not curable with standard therapy.
- •At least one measurable lesion
- •ECOG Performance Status less than or equal to 2
- •Acceptable hematologic status
- •Albumin greater than or equal to 2.5 g/dL
- •Normal calculated glomerular filtration rate (GFR)
- •Acceptable liver function
排除标准
- •Uncontrolled cardiac disease, angina, congestive heart failure, or myocardial infarction within 6 months prior to Study Day
- •Known history of hepatitis B or C, or HIV infection
- •Clinically significant effusions, including pericardial, pleural, and ascites
- •Serious non-malignant disease
- •Central nervous system (CNS) metastatic involvement except where the disease has been successfully treated
- •Investigational therapies within 4 weeks of Study Day 1
- •Radiation therapy of tumors to be followed for this study
- •Chemotherapy, biologic therapy, or major surgery other than diagnostic within 4 weeks prior to Study Day 1
- •Current Grade 3 or 4 neurological toxicity
- •Concurrent anti-neoplastic therapy and/or steroids
结局指标
主要结局
To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors
时间窗: up to 2 years
次要结局
- To define the recommended Phase II dose of hCBE-11(up to 2 years)
研究者
研究点 (4)
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