[Translation] An open-label, exploratory (Phase I/IIA) clinical study evaluating the safety, tolerability, and pharmacokinetic characteristics of BJ-005 in Chinese patients with advanced solid tumors
主要目的:
考察静脉输注(IV)给药不同剂量BJ-005在晚期实体瘤成年患者中的安全性和耐受性。
探索BJ-005的最大耐受剂量(MTD)和/或II期临床试验推荐剂量(RP2D)。
次要目的:
考察BJ-005在晚期实体瘤成年患者中的初步有效性。
考察IV给药下BJ-005在晚期实体瘤成年患者中的PK特征。
考察BJ-005在晚期实体瘤成年患者中的免疫原性。
考察BJ-005给药方案对药效动力学(PD)参数的影响,PD参数包括但不限于:血样中总PD-L1水平、游离TGF-β1水平、细胞因子IL-1β、IL2、IL4、IL6、IL10、IL17、IFN-γ和TNF-α。
[Translation] Primary objectives:
To investigate the safety and tolerability of different doses of BJ-005 administered by intravenous infusion (IV) in adult patients with advanced solid tumors.
To explore the maximum tolerated dose (MTD) and/or recommended dose (RP2D) of BJ-005 for Phase II clinical trials.
Secondary objectives:
To investigate the preliminary efficacy of BJ-005 in adult patients with advanced solid tumors.
To investigate the PK characteristics of BJ-005 in adult patients with advanced solid tumors under IV administration.
To investigate the immunogenicity of BJ-005 in adult patients with advanced solid tumors.
To investigate the effect of BJ-005 dosing regimen on pharmacodynamic (PD) parameters, including but not limited to: total PD-L1 level, free TGF-β1 level, cytokines IL-1β, IL2, IL4, IL6, IL10, IL17, IFN-γ and TNF-α in blood samples.