NCT01166490已完成1 期
A Phase 1, Open-Label, Dose Escalation Study of ASG-5ME in Patients With Pancreatic or Gastric Adenocarcinoma
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
- 51
- 试验地点
- 7
- 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 and tolerability of ASG-5ME and identify the maximum tolerated dose in patients with pathologically confirmed metastatic pancreatic adenocarcinoma, and to evaluate safety and tolerability in patients with relapsed or refractory gastric adenocarcinoma.
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 metastatic pancreatic adenocarcinoma or pathologically confirmed AGS-5-positive gastric or gastric esophageal junction adenocarcinoma
- •Measurable disease (at least one nonresectable, non-nodal lesion greater than or equal to 10 mm in longest diameter or nodal lesion greater than or equal to 15 mm in shortest axis)
- •ECOG performance status of 0 or 1
- •May be untreated or have previously received treatment for pancreatic adenocarcinoma or must have relapsed or refractory disease following 1 prior systemic therapy for metastatic gastric adenocarcinoma. For patients who have previously received treatment, it must be at least 2 weeks since the last systemic therapy or radiation, and at least 4 weeks since treatment with any monoclonal antibody (other than bevacizumab).
排除标准
- •Evidence or history of central nervous system metastases
- •History of another primary malignancy that has not been in remission for at least 3 years
- •Documented history of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with NYHA Class III-IV within 6 months prior
研究组 & 干预措施
1
Experimental
ASG-5ME
干预措施: ASG-5ME (Drug)
结局指标
主要结局
Incidence of adverse events and laboratory abnormalities
时间窗: Through 1 month after last dose
次要结局
- Best clinical response(Every 2 months)
- Incidence of antitherapeutic antibodies in blood(Through 1 month after last dose)
- Concentrations of ASG-5ME and metabolites in blood(Through 1 month after last dose)
- Overall and progression-free survival(Every month until death or study closure)
研究者
研究点 (7)
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