NCT00231166已完成1 期
A Phase I, Dose-finding Trial of HCD122, an Anti-CD40 Monoclonal Antibody, in Patients With Multiple Myeloma That is Relapsed or Has Not Responded to Prior Therapy (CHIR1212-C12101)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- Safety, pharmacokinetics and pharmacodynamics at multiple doses
研究概览
简要总结
The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with Multiple Myeloma who are relapsed after receiving prior treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Diagnosis of MM requiring treatment
- •Refractory or Relapsed Disease
- •At least one prior treatment regimen
- •Male or Female
- •>18 years of age
排除标准
- •Prior Allogeneic bone marrow transplant (prior autologous transplant allowed)
- •Intracranial disease or epidural disease
- •Clinically significant cardiac dysfunction or other significant organ dysfunction
研究组 & 干预措施
HCD122
Experimental
干预措施: HCD122 (Drug)
结局指标
主要结局
Safety, pharmacokinetics and pharmacodynamics at multiple doses
时间窗: At the completion of each dose escalation cohort
次要结局
- Clinical response after various doses(Once a month)
研究者
研究点 (6)
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