NCT01677390终止1 期
A Phase 1b, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Combination With Everolimus in Patients With CD70-positive Metastatic Renal Cell Carcinoma
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
- Seagen Inc.
- 入组人数
- 4
- 试验地点
- 8
- 主要终点
- Incidence of adverse events and laboratory abnormalities
研究概览
简要总结
This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of SGN-75 in combination with everolimus in patients with CD70-positive metastatic renal cell carcinoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of metastatic renal cell carcinoma with confirmed CD70 expression
- •Previously treated with at least 1 tyrosine kinase inhibitor (TKI)
- •Measurable disease
- •Eastern Cooperative Oncology Group performance status 0 or 1
- •Adequate lung and renal function
排除标准
- •Prior treatment with anti-CD70-directed therapy
- •Received more than one prior treatment with an mTOR inhibitor
研究组 & 干预措施
Arm 1
Experimental
SGN-75, everolimus
干预措施: SGN-75 (Drug)
Arm 1
Experimental
SGN-75, everolimus
干预措施: everolimus (Drug)
结局指标
主要结局
Incidence of adverse events and laboratory abnormalities
时间窗: Through 1 month post last dose
次要结局
- Best clinical response according to RECIST Version 1.1(Through 1 month post last dose)
- Overall survival(Until death or study closure, an expected average of 1 year)
- Blood concentrations of SGN-75 and metabolites(Cycle 1: pre-dose, 30 minutes, and 2, 4, 8, 24, 168, and 336 hours post dose start; pre-dose in subsequent cycles, and 1 month post last dose)
- Incidence of antitherapeutic antibodies(Pre-dose in most cycles and 1 month post last dose)
- Progression-free survival(Until disease progression or start of new anticancer treatment, an expected average of 6 months)
研究者
研究点 (8)
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