NCT00909025已完成1 期
Clinical First-in-human Single-dose Escalation Study Evaluating the Safety and Tolerability of Claudiximab (iMAB-362) in Hospitalized Patients With Advanced Gastroesophageal Cancer. A Multi-center, Phase I, Open-label, i.v. Infusion Study
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Determination of maximum tolerated dose of claudiximab (Phase I: toxicities as assessed by NCI CTCAE version 3.0)
研究概览
简要总结
Claudiximab is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. Preclinically, claudiximab was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase I study is to establish safety, toxicity and maximal tolerable dose of a single infusion of claudiximab in patients suffering from relapsing, advanced gastroesophageal and 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
- Other
- 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 gastroesophageal cancer (adenocarcinoma) proven by histology
- •CLDN18.2 expression confirmed by immunohistochemistry
- •Prior standard chemotherapy containing a fluoropyrimidine, a platinum compound and/or epirubicine, and - if clinically appropriate - docetaxel
- •At least 1 measurable site of the disease according RECIST criteria (CT-scans or MRT not older than 6 weeks before study entry)
- •Age ≥ 18 years
- •ECOG performance status (PS) 0-1 or Karnofsky Index 70-100%
- •Life expectancy > 3 months
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 10 g/dl
- •INR < 1.5
- •Bilirubin normal
- •AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- •Creatinine < 1.5 x ULN
排除标准
- •Pregnancy or breastfeeding
- •Prior allergic reaction or intolerance to a monoclonal antibody
- •Prior inclusion in the present study
- •Less than 3 weeks since prior anti-tumor or radiation therapy
- •Other investigational agents or devices concurrently or within 4 weeks prior to this study
- •Other concurrent anticancer therapies
- •History of positive test for human immunodeficiency virus (HIV) antibody
- •Known Hepatitis.
- •Uncontrolled or severe illness.
- •Concurrent administration of anticoagulation agents with vitamin K antagonists
- •Concurrent administration of therapeutic doses of heparin (prophylactic doses are acceptable)
研究组 & 干预措施
Claudiximab
Experimental
干预措施: Claudiximab (Drug)
结局指标
主要结局
Determination of maximum tolerated dose of claudiximab (Phase I: toxicities as assessed by NCI CTCAE version 3.0)
时间窗: Four weeks
次要结局
- Overall tumor response as assessed by RECIST(Four weeks)
- Pharmacokinetic evaluation(Four weeks)
- Determination of the safety profile(Four weeks)
- Evaluation of immunogenicity(Four weeks)
- Determination of antitumoral efficacy(Four weeks)
研究者
研究点 (6)
Loading locations...
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