[Translation] A Phase Ib/IIa clinical trial evaluating the safety, tolerability, and pharmacokinetic characteristics of BAT8001 combined with BAT1306 in patients with HER2-positive advanced solid tumors
主要目的 评价BAT8001联合BAT1306治疗HER2阳性晚期实体瘤患者的安全性和耐受性,并探索最大耐受剂量(MTD),确定Ⅱ期临床试验推荐剂量(RP2D)。 次要目的 (1)评价BAT8001联合BAT1306的药代动力学(PK)及免疫原性特征。 (2)初步评价BAT8001联合BAT1306的抗肿瘤疗效。 探索性目的 探索BAT8001联合BAT1306治疗晚期实体瘤患者的疗效相关的生物标志物。
[Translation] Primary objective: To evaluate the safety and tolerability of BAT8001 combined with BAT1306 in the treatment of patients with HER2-positive advanced solid tumors, explore the maximum tolerated dose (MTD), and determine the recommended dose (RP2D) for Phase II clinical trials. Secondary objectives: (1) To evaluate the pharmacokinetic (PK) and immunogenicity characteristics of BAT8001 combined with BAT1306. (2) To preliminarily evaluate the anti-tumor efficacy of BAT8001 combined with BAT1306. Exploratory objectives: To explore biomarkers related to the efficacy of BAT8001 combined with BAT1306 in the treatment of patients with advanced solid tumors.