[Translation] An open-label phase I/II clinical study of dose escalation and expansion cohorts to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of ABP1019A tablets in patients with advanced solid tumors
(一)I期研究目的
1、主要研究目的
评估ABP1019A片在晚期实体瘤患者中的安全性和耐受性;确定后继临床试验推荐剂量(RP2D)以及给药方案。
2、次要研究目的
研究ABP1019A片单次和多次给药在晚期实体瘤患者中的药代动力学(PK)特征;
初步评估ABP1019A片的心脏安全性,包括校正QT间期(QTc)延长的可能性,并评估PK/QTc关系;
初步评估ABP1019A片治疗晚期实体瘤的有效性。
(二)II期研究目的
1、主要研究目的
初步评估ABP1019A片在目标晚期实体瘤患者中的有效性。
2、次要研究目的
评估ABP1019A片在目标晚期实体瘤患者中的安全性。
[Translation] (1) Purpose of Phase I study
1. Main research purpose
Evaluate the safety and tolerability of ABP1019A tablets in patients with advanced solid tumors; determine the recommended dose (RP2D) and dosing regimen for subsequent clinical trials.
2. Secondary research purpose
Study the pharmacokinetic (PK) characteristics of single and multiple administrations of ABP1019A tablets in patients with advanced solid tumors;
Preliminary evaluation of the cardiac safety of ABP1019A tablets, including the possibility of correcting for QT interval (QTc) prolongation, and assessment of the PK/QTc relationship;
To initially evaluate the effectiveness of ABP1019A tablets in the treatment of advanced solid tumors.
(2) Purpose of Phase II study
1. Main research purpose
To initially evaluate the effectiveness of ABP1019A tablets in targeted patients with advanced solid tumors.
2. Secondary research purpose
To evaluate the safety of ABP1019A tablets in patients with targeted advanced solid tumors.