ANTIVITRONECTIN RECEPTOR HUMANIZED MONOCLONAL ANTIBODY IN METASTATIC CANCER

抗玻连蛋白受体人源化单克隆抗体治疗转移性癌症

• 批准号: 6263449
• 负责人: James A Posey
• 金额: $ 2.95万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6263449
• 关键词: antibody receptor; antineoplastics; antireceptor antibody; clinical research; clinical trials; human subject; metastasis; monoclonal antibody; neoplasm /cancer therapy; pharmacokinetics; radiotracer; receptor; vitronectin

This is an open label Phase I study of Vitaxin to establish any toxicity/ adverse events over a limited dose range given as two infusions 3 weeks apart at doses of 10 mg, 50 mg, or 200 mg. Pharmacokinetics, antibody response to Vitaxin (HAMA) and anti-tumor effects will be documented. The ability of 99Tc-Vitaxin (imaging probe) to ocalize to tumor sites will be determined prior to Vitaxin infusion and, if localization occurs, follow-up 99Tc-V probe studies will be done to assess the effect of Vitaxin treatment on radiolocalization (available 6v' sites). We recognize that this use of radiolabeled antibody to analyze available antigen sites is novel but we believe that the vascular site of 6v'3 targets may make this approach feasible. The initial Phase I trial observed a short T1/2 at the 0.1 mg/kg dose level suggesting that the imaging strategy may work. The study will provide worthwhile observations relevant to Vitaxin tolerance, pharmacokinetics, HAMA, and anti-tumor effects with potential to provide novel observations on receptor binding and "blockade."

这是一项Vitaxin的开放式标签I期研究，旨在确定在有限的剂量范围内，以10毫克、50毫克或200毫克的剂量进行两次相隔3周的输注，是否存在任何毒性/不良事件。药代动力学、对Vitaxin的抗体反应(HAMA)和抗肿瘤作用将被记录在案。99TC-Vitaxin(成像探针)定位到肿瘤部位的能力将在注射Vitaxin之前确定，如果发生定位，将进行后续的99TC-V探针研究，以评估Vitaxin治疗对放射定位的影响(可用6v‘部位)。我们认识到，使用放射性标记抗体来分析可用的抗原部位是新的，但我们相信6v‘3靶点的血管部位可能使这种方法可行。最初的I期试验观察到0.1 mg/kg剂量水平的短T1/2，表明成像策略可能有效。该研究将提供与Vitaxin耐受性、药代动力学、HAMA和抗肿瘤效应相关的有价值的观察结果，并有可能为受体结合和“阻断”提供新的观察结果。