[Translation] An open, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BL0006 in subjects with advanced solid tumors
主要目的:评价BL0006在晚期实体肿瘤受试者中的安全性和耐受性,探索最大耐受剂量(MTD)和II期推荐剂量(RP2D)。
次要目的:评价BL0006在晚期实体肿瘤受试者中的药代动力学(PK)特征;评价BL0006在晚期实体肿瘤受试者中的初步疗效。
探索性目的:如条件允许,探索剂量、暴露量和响应之间的关系。
[Translation] Primary objective: To evaluate the safety and tolerability of BL0006 in subjects with advanced solid tumors, and to explore the maximum tolerated dose (MTD) and the recommended dose for Phase II (RP2D).
Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of BL0006 in subjects with advanced solid tumors; to evaluate the preliminary efficacy of BL0006 in subjects with advanced solid tumors.
Exploratory objective: To explore the relationship between dose, exposure, and response, if conditions permit.