ANTIVITRONECTIN RECEPTOR HUMANIZED MONOCLONAL ANTIBODY IN METASTATIC CANCER

这是一项开放标签的I期研究，旨在确定在有限剂量范围内，以10mg、50mg或200mg的剂量间隔3周两次输注的任何毒性/不良事件。将记录药代动力学、对维他素（HAMA）的抗体反应和抗肿瘤作用。99Tc-Vitaxin（成像探针）定位肿瘤部位的能力将在输注维他素之前确定，如果定位发生，将进行99Tc-V探针的后续研究，以评估维他素治疗对放射定位（可用的6v位点）的影响。我们认识到这种使用放射性标记抗体来分析可用抗原位点的方法是新颖的，但我们相信6v'3靶点的血管位点可能使这种方法可行。最初的I期试验在0.1 mg/kg剂量水平下观察到短T1/2，这表明成像策略可能有效。该研究将提供有关维他素耐受性、药代动力学、HAMA和抗肿瘤作用的有价值的观察结果，并有可能提供有关受体结合和“阻断”的新观察结果。

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."