NCT00309023终止1 期
A Phase I/II, Ascending Multi-Dose Study of BMS-663513, An Agonistic Anti-CD137 Monoclonal Antibody, Administered Every Three Weeks to Patients With Metastatic or Locally Advanced Solid Malignancies
Bristol-Myers Squibb7 个研究点 分布在 2 个国家目标入组 115 人开始时间: 2005年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 115
- 试验地点
- 7
- 主要终点
- Assess Safety (Number and distribution and severity adverse events) of subjects
研究概览
简要总结
This is a Phase I/II, ascending, multi-dose study of BMS-663513, an agonistic anti-CD137 monoclonal antibody, administered every three weeks to patients with metastatic or locally advanced 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
- •Eastern Cooperative Oncology Group (ECOG) score of 0-
- •Measurable disease.
- •Absolute neutrophil count (ANC) >= 1,500 cells/mm3
- •Platelet count >= 100K cells/mm3
- •Hemoglobin >= 9.0 g/dL
- •Total bilirubin <= 1.5 x IULN
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase <= 2.5 x institutional upper limit of normal (IULN)
- •Patients with advanced solid malignancies must have melanoma, renal or ovarian carcinoma
排除标准
- •History of autoimmune diseases.
- •Condition requiring the continued use of systemic or topical steroids or the use of immunosuppressive agents.
- •Active/symptomatic brain metastasis.
- •History of hepatitis B or C.
- •Concurrent malignancy.
研究组 & 干预措施
dose escalation
Experimental
干预措施: BMS-663513 (Drug)
结局指标
主要结局
Assess Safety (Number and distribution and severity adverse events) of subjects
时间窗: Active treatment of a minimum of 3 months up until disease progression or toxicity; and long-term follow-up to assess time to progression or death will conclude 2 years after the last treatment with BMS-663513.
次要结局
- Assess pharmacokinetic parameters deriving from serum concentration versus time data(Cycle 1 Day 1, Cycle 2 Day 1 and 28, Cycle 3 Day 1 and 8, and Day 1 of every cycle the subject is on study from Cycle 4 and greater; and at study discharge.)
- Efficacy by evaluation of tumor response(At week 12 and every 6 weeks thereafter. Follow-up up to 2 years after last dose of study drug)
- Assess pharmacodynamic and immune response analysis(up to 60 days after last dose of study drug)
研究者
研究点 (7)
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