[Translation] A Phase I, open-label, multicenter study to explore the safety, tolerability, pharmacokinetics, and preliminary efficacy of oral BB3008 tablets in patients with advanced solid tumors
主要目的:
(1)评估不同剂量 BB3008 片单药治疗晚期实体瘤受试者的安全性和耐受性,确定
BB3008 片的 MTD,为 RP2D 的确定提供依据;
次要目的:
(1) 评估 BB3008 片在晚期实体瘤受试者体内的 PK 特性;
(2)初步评估 BB3008 片单药治疗晚期实体瘤受试者的疗效;
(3)初步鉴定 BB3008 在晚期实体瘤患者中的代谢产物(如有);
探索性目的:
(1)探索与 BB3008 药物疗效和安全性相关的生物标志物;
(2)探索血药浓度和 Fridericia 法校正的 QT 间期(QTcF)的相关性(C-QTcF 分析)。
[Translation] Primary objectives:
(1) To evaluate the safety and tolerability of different doses of BB3008 tablets as a monotherapy in subjects with advanced solid tumors, determine the MTD of BB3008 tablets, and provide a basis for the determination of RP2D;
Secondary objectives:
(1) To evaluate the PK characteristics of BB3008 tablets in subjects with advanced solid tumors;
(2) To preliminarily evaluate the efficacy of BB3008 tablets as a monotherapy in subjects with advanced solid tumors;
(3) To preliminarily identify the metabolites of BB3008 in patients with advanced solid tumors (if any);
Exploratory objectives:
(1) To explore biomarkers related to the efficacy and safety of BB3008;
(2) To explore the correlation between blood drug concentration and Fridericia-corrected QT interval (QTcF) (C-QTcF analysis).