[Translation] A non-randomized, open-label, multicenter Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BA1106 injection in patients with advanced solid tumors
主要目的 评价BA1106注射液的安全耐受性,观察剂量限制性毒性(DLT),确定最大耐受剂量(MTD)。 次要目的 在晚期实体瘤患者中评价BA1106的药代动力学(PK)特征、免疫原性和初步疗效。 探索目的 (1)分析给药后各时间点与基线相比,外周血和/或肿瘤内淋巴细胞亚群计数(包括调节性T细胞Treg、效应T细胞Teff)、Teff/Treg变化,及其与安全性/疗效的相关性; (2)分析给药后各时间点与基线相比,外周血中细胞因子变化,及其与安全性/疗效的相关性。
[Translation] Primary objective: To evaluate the safety and tolerability of BA1106 injection, observe dose-limiting toxicity (DLT), and determine the maximum tolerated dose (MTD). Secondary objective: To evaluate the pharmacokinetic (PK) characteristics, immunogenicity, and preliminary efficacy of BA1106 in patients with advanced solid tumors. Exploratory objectives: (1) To analyze the changes in peripheral blood and/or intratumoral lymphocyte subset counts (including regulatory T cells Treg, effector T cells Teff), Teff/Treg, and their correlation with safety/efficacy at each time point after administration compared with baseline; (2) To analyze the changes in peripheral blood cytokines compared with baseline at each time point after administration, and their correlation with safety/efficacy.