NCT02216890已完成1 期
A Phase 1 Trial of SGN-CD70A in Patients With CD70-Positive Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 38
- 试验地点
- 17
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This study will examine the safety profile of SGN-CD70A. The study will test increasing doses of SGN-CD70A given every 3 weeks (or an alternate dosing schedule up to every 6 weeks) to small groups of patients. The goal is to find the highest dose of SGN-CD70A that can be given to patients without causing unacceptable side effects. The pharmacokinetics and antitumor activity of SGN-CD70A will also be evaluated.
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
- •Metastatic renal cell carcinoma, mantle cell lymphoma, or diffuse large B-cell lymphoma including Grade 3b follicular lymphoma
- •Relapsed, refractory, or progressive disease following at least 2 prior systemic therapies
- •Confirmed positive CD70 expression on tumor tissue
- •Eastern Cooperative Oncology Group performance status 0 or 1
- •Adequate baseline hematologic, pulmonary, renal, and hepatic function
- •Measurable disease
排除标准
- •Prior treatment with anti-CD70 directed therapy unless CD70 expression is confirmed on tumor tissue obtained after the treatment
- •Patients <100 days since prior allogeneic stem cell transplant
- •Less than 4 weeks since prior treatment; or 2 weeks if patient experienced disease progression on the prior treatment
研究组 & 干预措施
SGN-CD70A
Experimental
干预措施: SGN-CD70A (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Through 1 month following last dose
Incidence of laboratory abnormalities
时间窗: Through 1 month following last dose
次要结局
- Blood concentrations of SGN-CD70A and metabolites(Through 3 to 6 weeks after dosing)
- Incidence of antitherapeutic antibodies(Through 1 month following last dose)
- Objective response rate(Through 1 month following last dose)
- Progression-free survival(Approximately 3 years)
- Duration of response(Approximately 3 years)
研究者
研究点 (17)
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