[Translation] A multicenter, open-label, Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of YL205 in patients with advanced solid tumors
主要目的:
评估YL205在局部晚期或转移性实体瘤患者中的安全性,有效性和耐受性;
在晚期实体瘤患者中确定YL205的最大耐受剂量、推荐扩展剂量和Ⅱ期推荐剂量(RP2D)。
次要目的:
评估YL205总抗体、游离毒素以及潜在代谢物的药代动力学特征;
评价YL205的免疫原性;
初步评价YL205在治疗晚期实体瘤患者中的有效性。
[Translation] Primary objectives:
Evaluate the safety, efficacy and tolerability of YL205 in patients with locally advanced or metastatic solid tumors;
Determine the maximum tolerated dose, recommended expansion dose and phase II recommended dose (RP2D) of YL205 in patients with advanced solid tumors.
Secondary objectives:
Evaluate the pharmacokinetic characteristics of YL205 total antibody, free toxin and potential metabolites;
Evaluate the immunogenicity of YL205;
Preliminary evaluation of the effectiveness of YL205 in the treatment of patients with advanced solid tumors.