[Translation] Phase I clinical study on the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of recombinant anti-EGFR human-mouse chimeric monoclonal antibody injection BK011 in patients with advanced malignant solid tumors
主要目的:
观察BK011治疗晚期实体瘤患者的安全性和耐受性;
确定BK011的最大耐受剂量(MTD)和后续研究的合适推荐剂量(RD);
次要目的:
评价BK011的药代动力学特征及免疫原性;
初步评价BK011治疗晚期实体瘤患者的有效性;
[Translation] Primary purpose:
Observe the safety and tolerability of BK011 in the treatment of patients with advanced solid tumors;
Determine the maximum tolerated dose (MTD) of BK011 and the appropriate recommended dose (RD) for subsequent studies;
Secondary purpose:
Evaluate the pharmacokinetic characteristics and immunogenicity of BK011;
Preliminary evaluation of the effectiveness of BK011 in the treatment of patients with advanced solid tumors;