NCT01015911已完成1 期
A Phase 1, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Patients With CD70-positive Relapsed or Refractory Non-Hodgkin Lymphoma or 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
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 58
- 试验地点
- 9
- 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 patients with CD70-positive relapsed or refractory non-Hodgkin lymphoma or 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
- •Pathologically-confirmed diagnosis of NHL or RCC
- •Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy
- •Confirmed CD70 expression
- •Measurable disease, defined as at least 1 lesion >1.5 cm in the greatest transverse diameter for patients with NHL, and at least 1 non-resectable tumor lesion > or equal to 10 mm in diameter for patients with RCC
排除标准
- •Previously received an allogeneic transplant
- •History of another primary malignancy that has not been in remission for at least 3 years
- •Prior anti-CD70-directed therapy
研究组 & 干预措施
1
Experimental
SGN-75
干预措施: SGN-75 (Drug)
结局指标
主要结局
Incidence of adverse events and laboratory abnormalities
时间窗: Through 1 month following last dose
次要结局
- Duration of response, progression-free survival(Every 3 months until progression of disease or initiation of new treatment for cancer)
- Blood concentrations of SGN-75 and metabolites(Through 1 month following last dose)
- Incidence of antitherapeutic antibodies(Through 1 month following last dose)
- Best clinical response(Every 2 months)
研究者
研究点 (9)
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