Phase I Study of Preoperative Detection of Colorectal Carcinoma With Bispecific Antibody Pretargeting
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Pharmacokinetics
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as radionuclide imaging using bispecific antibody, may help find colorectal cancer cells and learn the extent of disease.
PURPOSE: This phase I trial is studying how well a bispecific antibody works in finding tumor cells in patients with colorectal cancer.
详细描述
OBJECTIVES:
- Assess the pharmacokinetics and tissue distribution of anti-CEA x anti-HSG bispecific monoclonal antibody TF2 in patients with colorectal cancer.
OUTLINE: This is a multicenter study.
Patients receive iodine I 131-labeled anti-CEA x anti-HSG bispecific monoclonal antibody TF2 (^131I-TF2) IV over 10-20 minutes on day 1. Patients also undergo whole-body external scintigraphy at various times during the study.
Blood samples are collected at baseline and periodically after ^131I-TF2 infusion for pharmacokinetic studies and ^131I-TF2 biodistribution by ELISA and radioactivity measurements.
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed colorectal cancer
- •Radiological documentation of disease is preferred, but not required
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 70-100%
- •Life expectancy ≥ 3 months
- •WBC ≥ 3,000/mm³
- •Neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Serum creatinine normal
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST/ALT < 2 times ULN
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 1 month after completion of study therapy
- •No medical conditions that might prevent full participation in protocol-required testing or follow-up
- •No institutionalized patients (e.g., in prisons or mental health institutions)
- •PRIOR CONCURRENT THERAPY:
- •No concurrent chemotherapy or treatments that would compromise the safety and efficacy of protocol assessments
排除标准
- 未提供
结局指标
主要结局
Pharmacokinetics
Tissue distribution
次要结局
未报告次要终点