[Translation] A Phase Ia clinical trial of the safety, pharmacokinetic characteristics, and preliminary efficacy of recombinant anti-LAG-3 humanized monoclonal antibody (JY03) injection in patients with metastatic advanced solid tumors.
主要目的:评价JY03注射液在转移性晚期实体瘤患者中的安全性。
次要目的:
(1)评价JY03注射液在转移性晚期实体瘤患者中的其他安全性;
(2)评价JY03注射液在转移性晚期实体瘤患者中的药代动力学特征(PK);
(3)评价JY03注射液在转移性晚期实体瘤患者中的免疫原性;
(4)评价JY03注射液在转移性晚期实体瘤患者中的有效性。
探索性目的:
(1)评价LAG-3表达水平与有效性的关系;
(2)评价JY03注射液治疗后T细胞的激活与有效性的关系。
[Translation] Primary Objective: To evaluate the safety of JY03 injection in patients with metastatic advanced solid tumors.
Secondary Objectives:
(1) To evaluate other safety profiles of JY03 injection in patients with metastatic advanced solid tumors;
(2) To evaluate the pharmacokinetic characteristics (PK) of JY03 injection in patients with metastatic advanced solid tumors;
(3) To evaluate the immunogenicity of JY03 injection in patients with metastatic advanced solid tumors;
(4) To evaluate the efficacy of JY03 injection in patients with metastatic advanced solid tumors.
Exploratory Objectives:
(1) To evaluate the relationship between LAG-3 expression levels and efficacy;
(2) To evaluate the relationship between T cell activation and efficacy after treatment with JY03 injection.