[Translation] An open-label, multicenter, dose-finding Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of THZ0106 in patients with locally advanced or metastatic solid tumors
主要目的:
评价THZ0106的安全性和耐受性;
确定THZ0106的最大耐受剂量(MTD)。
次要目的:
评价THZ0106的药代动力学(PK)特征;
评价THZ0106的免疫原性;
根据实体瘤疗效评价标准(RECIST v1.1)疗效指标,初步评价THZ0106的抗肿瘤疗效。
探索性目的:
探索THZ0106的药效动力学特征;
探索潜在的生物标记物。
[Translation] Primary objectives:
Evaluate the safety and tolerability of THZ0106;
Determine the maximum tolerated dose (MTD) of THZ0106.
Secondary objectives:
Evaluate the pharmacokinetic (PK) characteristics of THZ0106;
Evaluate the immunogenicity of THZ0106;
Preliminary evaluation of the anti-tumor efficacy of THZ0106 based on the efficacy indicators of the solid tumor efficacy evaluation criteria (RECIST v1.1).
Exploratory objectives:
Explore the pharmacodynamic characteristics of THZ0106;
Explore potential biomarkers.