NCT00860860已完成1 期
Phase I Clinical Study of the Feasibility of Pretargeted Radioimmunotherapy of an Anti-CEA Bispecific Antibody and Lu-177-labeled Peptide in Patients With Advanced Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Toxicity defined by NCI Common Terminology Criteria for Adverse Events version 3.0
研究概览
简要总结
This study will investigate the toxicity, safety and pharmacokinetics of pretargeted radioimmunotherapy with anti-CEA x anti-hapten bispecific antibody TF2 and Lu-177-labeled di-HSG-DOTA peptide IMP-288. Furthermore, the sensitivity of pretargeted imaging with In-111-labeled IMP-288 as compared to standard methods of tumor detection, and the preliminary efficacy of the therapy.
详细描述
Pretherapy cycle with IMP-288 labeled In111.
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
- •Patients with CEA expressing advanced colorectal tumors for which no standard treatment is available
- •WHO performance status: 0 or 1
- •Having normal hematological function: Neutrophils > 1.5 x 109/l; Platelet count > 150 x 109/l, without transfusion during the previous month; Hemoglobin > 5.6 mmol/l
- •Total bilirubin < 2 x upper limit of normal (ULN)
- •ASAT, ALAT < 3 x ULN
- •Serum creatinine < 2 x ULN
- •Cockcroft clearance > 50 ml/min
- •Negative pregnancy test for women of child¬bearing potential (urine or serum)
- •Age over 18 years
- •Ability to provide written informed consent
排除标准
- •Known metastases to the brain
- •Chemotherapy, external beam radiation or immunotherapy within 4 weeks prior to study. Limited field external beam radiotherapy to prevent pathological fractures is allowed, when unirradiated, evaluable lesions elsewhere are present.
- •Prior angiogenesis inhibitors within 4 weeks; bevacizumab within 8 weeks
- •Cardiac disease with New York Heart Association classification of III or IV
- •Patients who are pregnant, nursing or of reproductive potential and are not practicing an effective method of contraception
- •Any unrelated illness, e.g. active infection, inflammation, medical condition or laboratory abnormalities, which in the judgement of the investigator will significantly affect patients' clinical status
- •Life expectancy shorter than 6 months.
结局指标
主要结局
Toxicity defined by NCI Common Terminology Criteria for Adverse Events version 3.0
时间窗: first three weeks: daily, thereafter: weekly
次要结局
- pharmacokinetics and biodistribution of TF2 and Lu-177-labeled IMP-288, sensitivity of pretargeted imaging with In-111-labeled IMP-288, and tumor response using RECIST criteria(Pk/biodistr: first week after administration; imaging: first 5 days after administration of IMP-288-In111; tumor respone: every 8 weeks)
研究者
研究点 (2)
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