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PNU-214565是一种C242单克隆抗体Fab片段与葡萄球菌肠毒素A(SEA)重组Escherichia coli衍生的融合蛋白。为确立癌病人对该药一次性输注的最大耐受量及明确其毒性,首次进行Ⅰ期临床研究,这也是第一个应用能定向肿瘤部位的细胞上层抗原(SAg)免疫偶联物的临床治疗试验。 共治疗22例晚期癌病人,其中胰腺癌3例,直肠癌5例,结肠癌13例。病人年龄39～76岁。所有病人先前
PNU-214565 is a C242 monoclonal antibody Fab fragment and Staphylococcus enterotoxin A (SEA) recombinant Escherichia coli derived fusion protein. In order to establish the maximum tolerated dose and its toxicity of a one-time infusion of this drug in cancer patients, a Phase I clinical study was conducted for the first time. This was the first application of a cell-surface antigen (SAg) immunoconjugate capable of targeting a tumor site. Clinical treatment trials. A total of 22 cases of advanced cancer patients were treated, including 3 cases of pancreatic cancer, 5 cases of rectal cancer, and 13 cases of colon cancer. The patient’s age was 39-76 years old. All patients previously