A Phase I Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4, in Patients With Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 主要终点
- Number of patients with abnormal changes in laboratory parameters
研究概览
简要总结
The primary objectives of this study is to assess the safety and tolerability of intravenously (i.v.) administered 186 Rhenium-isotope (186Re)-labelled bivatuzumab and to investigate the biodistribution and pharmacokinetics of 186 Re-labelled bivatuzumab in patients with non-small cell lung cancer (NSCLC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histological or cytological confirmation of Non small cell lung cancer (NSCLC) stage I, II or IIIa according to the staging system of the American Joint Committee on Cancer (AJCC)
- •Patients destined for resection of the tumour
- •Patients over 18 years of age
- •Patients younger than 80 years of age
- •Patients who had given 'written informed consent'
- •Patients with a life expectancy of at least 3 months
- •Patients with a good performance status: Karnofsky > 60
排除标准
- •Life-threatening infection, allergic diathesis, organ failure (bilirubin > 30µmol/l and/or creatinine > 150 µmol/l) or evidence of a recent myocardial infarction on Electrocardiogram (ECG) or unstable angina pectoris
- •Pre-menopausal women (last menstruation <= 1 year prior to study start)
- •Not surgically sterile (hysterectomy, tubal ligation) and
- •Not practicing acceptable means of birth control, (or not planned to be continued throughout the study). Acceptable methods of birth control include oral, implantable or injectable contraceptives
- •Women with a positive serum pregnancy test at baseline
- •White blood cell count < 3000/mm³, granulocyte count < 1500/mm³ or platelet count < 100000/mm³. Details of prior chemotherapy and radiotherapy had to be known.
- •Hematological disorders, congestive heart failure, bronchial asthma, alimentary or contact allergy, severe atopy or allergy
研究组 & 干预措施
hMAb BIWA 4
Bivatuzumab: 186 Re-labelled humanised monoclonal antibody BIWA 4
干预措施: hMAb BIWA 4 (Drug)
结局指标
主要结局
Number of patients with abnormal changes in laboratory parameters
时间窗: up to 6 weeks post infusion
Number of patients with clinically significant changes in vital signs
时间窗: up to 6 weeks post infusion
Presence of Human-Anti-Human-Antibody (HAHA)
时间窗: up to 6 weeks post infusion
Biodistribution of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples
时间窗: up to 96 hours post infusion
assessed by radioimmunoscintigraphy expressed as no, low, medium or high
Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples
时间窗: after surgery on day 8
Biodistribution assessed from biopsy sample as percentage of the injected dose per kg tissue (%ID/kg)
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
时间窗: up to 6 weeks post infusion
Cmax (Maximum measured concentration of the analyte in plasma)
时间窗: up to 6 weeks post infusion
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
时间窗: up to 6 weeks post infusion
t½ (Terminal half-life of the analyte in plasma)
时间窗: up to 6 weeks post infusion
Number of patients with adverse events
时间窗: up to 6 weeks post infusion
MRT (Mean residence time of the analyte in the body)
时间窗: up to 6 weeks post infusion
Vss (Apparent volume of distribution under steady state conditions)
时间窗: up to 6 weeks post infusion
Vz (Apparent volume of distribution during the terminal phase)
时间窗: up to 6 weeks post infusion
CL (Total body clearance)
时间窗: up to 6 weeks post infusion
次要结局
未报告次要终点