EUCTR2009-017365-36-BG进行中（未招募）1 期
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 - IMAB362 clinical study phase IIa-01 - GM-IMAB-001-02
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 confirmed by immunohistochemistry in paraffin embedded tumor tissue sample in at least 50 % of the tumor cells with a staining of at least 2+ (on a scale from 0 to +3)
- •- At least 1 measureable site of disease according to RECIST criteria (CT scans or MRI not older than 2 weeks before visit 2),
- •- Age = 18 years,
- •- Written Informed consent,
- •- ECOG performance status (PS) 0-1 or Karnofsky INdex 70-100%
- •- Life expectancy > 3 months,
- •- Platelet count = 100,000/mm³,
- •- Hemoglobin = 10 g/dl,
- •- 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,
- •- For women eith childbearing potential (last menstruation less than 2 years prior to enrolment): Negative pregnancy test (ß-HCG) at baseline and using two highly effective methods of contraception during the treatment phase and for 8 weeks after the last infusion of the study drug,
- •- Male patients whose sexual partners are women of child bearing potential must use an accepted contraceptive method during the treatment phase and for 8 weeks after the last infusion of the study drug.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients meeting any one or more of the following exclusion criteria are not eligible for study entry:
- •- Pregnancy or breastfeeding,
- •- Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies,
- •- Less than 3 weeks sinde prior chemo- or radiation therapy,
- •- Other investigational agents or devices concurrently or within 4 weeks prior to this study,
- •- Other concurrent anticancer therapies (not for the indication under study treatment),
- •- known HIV infection or known active hepatitis (A, B, C),
- •- Concurrent anticoagulation with vitamin K antagonists (e. g. Coumadin, Marcumar),
- •- Therapeutic doses of heparin (prophylactic doses are accepted),
- •- Uncontrolled illness including, but nor limited to, any of the following:
- •-- Ongoing or active infection requiring parenteral antibiotics
- •-- Symptomatic congestive heart failure
- •-- Unstable angina pectoris
- •-- Uncontrolled hypertension
- •-- Clinically significant cardiac arrhytmia
- •-- Myocardial infarction within the past 6 months
- •-- Gastric bleeding within last four weeks
- •-- Symptomatic peptic ulcer
- •-- Clinical symptoms of cerebral metastasis
- •- Psychiatric illness or social situations that would preclude study compliance
研究者
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