International, Multicenter, Open-label, Phase II Study to Investigate the Efficacy and Safety of Multiple Doses of IMAB362 in Patients With Advanced Adenocarcinoma of the Stomach or the Lower Esophagus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 21
- 主要终点
- Rate of remission (CR, PR) according to RECIST Criteria
研究概览
简要总结
IMAB362 is a monoclonal antibody specific for gastric or lower esophageal adenocarcinoma. Preclinically IMAB362 was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase II study is to establish efficacy and safety of multiple doses of IMAB362 as monotherapy in patients suffering from metastatic, refractory or recurrent adenocarcinoma of the stomach or the lower esophagus.
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, refractory or recurrent disease of advanced adenocarcinoma of the stomach or the lower esophagus proven by histology
- •CLDN18.2 expression of the biopsy material from the cancer confirmed by immunohistochemistry
- •At least 1 measurable site of disease according to RECIST criteria
排除标准
- •Less than 3 weeks since prior chemo-or radiation therapy
- •Other concurrent anticancer therapies
- •Concurrent anticoagulation with vitamin K antagonists
- •Therapeutic doses of Heparin (prophylactic doses accepted)
- •Uncontrolled or severe illness
研究组 & 干预措施
IMAB362
Two different doses (antibody / body surface area) of IMAB362 will be administered sequentially.
干预措施: IMAB362 (Drug)
结局指标
主要结局
Rate of remission (CR, PR) according to RECIST Criteria
时间窗: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion
次要结局
- Number of Participants with adverse events as a measure of safety and tolerability(All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion)
- Frequency and severity of adverse events according to CTCAE v3.0(All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion)
- Progression-free-survival time (PFS)(All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion)