ANTI-CARCINOMA MONOCLONAL ANTIBODIES CLINICAL TRIALS

该项目涉及在这两个领域使用单克隆抗体（MAbs） 诊断和治疗临床试验。 到目前为止，超过1,000名患者 在肿瘤靶向研究中给予放射性标记的B72.3 在许多机构进行了调查， 观察到约70 - 80%的肿瘤靶向。 选择性 在生物分布中证实了131-I MAb B72.3 IgG的定位 在结肠直肠癌患者中进行的研究中， 每克肿瘤的MAb剂量与正常对照组比较 组织，从而为每个组织提供相对放射定位指数（RI） 损伤。 在肿瘤病变中，70%的RI至少为3（即，3次 比正常组织更高的每克吸收）。 我们还进行了 研究以确定腹膜内给药的可行性 放射性标记的B72.3用于肿瘤定位（通过γ扫描和 活组织检查标本的直接分析）。 一项I期治疗试验，涉及腹膜内给予 131-I-B72. 3 IgG在卵巢癌和结直肠癌患者中的应用 腹膜腔的手术。 非常好的定位 腹部肿瘤病变的检测。 的使用 已经进行了重组/嵌合MAb。 临床试验涉及 第二代和第三代MAb-同位素偶联物使用 中求进工作总

This project involves the use of monoclonal antibodies (MAbs) in both diagnostic and therapeutic clinical trials. To date, over 1,000 patients have been administered radiolabeled B72.3 in tumor-targeting studies carried out in numerous institutions, with similar findings of approximately 70-80% tumor targeting observed. The selective localization of 131-I MAb B72.3 IgG was demonstrated in biodistribution studies in colorectal cancer patients in which the percentage of injected dose of MAb per gram of each tumor was compared with that of the normal tissues, thus providing a relative radiolocalization index (RI) for each lesion. Of the tumor lesions, 70% had an RI of at least 3 (i.e., 3 times greater uptake per gram than normal tissues). We have also conducted studies to determine the feasibility of intraperitoneal administration of radiolabeled B72.3 for tumor localization (via both gamma scanning and direct analysis of biopsy specimens). A phase I therapy trial involving intraperitonel administration of 131-I-B72.3 IgG in patients with ovarian or colorectal carcinoma confined to the peritoneal cavity has been conducted. Extremely good localization of tumor lesions in the abdomen was detected. The use of a recombinant/chimeric MAbs has been conducted. Clinical trials involving the use of second and third generation MAb-isotope conjugate are in progress.