[Translation] An open-label, multicenter Phase I clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of SYS6011 in subjects with advanced solid tumors.
主要目的:
1. 评估SYS6011在晚期实体瘤受试者中的安全性和耐受性
2. 确定SYS6011治疗晚期实体瘤受试者的II期推荐剂量(RP2D)
次要目的:
1. 评估SYS6011在晚期实体瘤受试者中的药代动力学(PK)特征
2. 评估SYS6011在晚期实体瘤受试者中的免疫原性
3. 评估SYS6011在晚期实体瘤受试者中的初步有效性
探索性目的:
探索肿瘤组织CD73表达水平与抗肿瘤活性的相关性
[Translation] Primary objectives:
1. Evaluate the safety and tolerability of SYS6011 in subjects with advanced solid tumors
2. Determine the Phase II recommended dose (RP2D) of SYS6011 for the treatment of subjects with advanced solid tumors
Secondary objectives:
1. Evaluate the pharmacokinetic (PK) characteristics of SYS6011 in subjects with advanced solid tumors
2. Evaluate the immunogenicity of SYS6011 in subjects with advanced solid tumors
3. Evaluate the preliminary efficacy of SYS6011 in subjects with advanced solid tumors
Exploratory objectives:
Explore the correlation between the expression level of CD73 in tumor tissues and anti-tumor activity