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Clinical Trials associated with Recombinant human anti-EGFR mAB(Shanghai Union Biopharm Co., Ltd.)GR1401在晚期肿瘤患者中的耐受性、药代动力学、免疫原性、剂量递增的安全性、初步疗效评价的I期临床试验
[Translation] Phase I clinical trial of GR1401 in patients with advanced tumors to evaluate its tolerability, pharmacokinetics, immunogenicity, safety of dose escalation, and preliminary efficacy
主要目的: 观察人体对不同剂量组的“GR1401”不良反应和不良反应特征并观察在设定剂量组中可能出现的最大耐受剂量(MTD),以及剂量限制性毒性(DLT) 次要目的: 考察单次和多次连续注射“GR1401”在人体内的药代动力学参数 考察单次和多次连续注射“GR1401”在人体内的免疫原性 考察“GR1401”在晚期实体瘤患者中的初步疗效(RECIST1.1方法)
[Translation] Primary purpose: To observe the adverse reactions and adverse reaction characteristics of "GR1401" in different dose groups and to observe the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) that may occur in the set dose groups. Secondary purpose: To investigate the pharmacokinetic parameters of single and multiple continuous injections of "GR1401" in humans. To investigate the immunogenicity of single and multiple continuous injections of "GR1401" in humans. To investigate the preliminary efficacy of "GR1401" in patients with advanced solid tumors (RECIST1.1 method).
100 Clinical Results associated with Recombinant human anti-EGFR mAB(Shanghai Union Biopharm Co., Ltd.)
100 Translational Medicine associated with Recombinant human anti-EGFR mAB(Shanghai Union Biopharm Co., Ltd.)
100 Patents (Medical) associated with Recombinant human anti-EGFR mAB(Shanghai Union Biopharm Co., Ltd.)
100 Deals associated with Recombinant human anti-EGFR mAB(Shanghai Union Biopharm Co., Ltd.)