[Translation] A Phase I/II clinical study with dose escalation and expansion cohorts to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of ABP1618 tablets in patients with advanced malignant solid tumors
(一)I期研究目的
1、主要研究目的
评估ABP1618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ABP1618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ABP1618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ABP1618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ABP1618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ABP1618片在目标晚期实体瘤患者中的安全性。
[Translation] (I) Objectives of Phase I Study
1. Primary Objectives
To evaluate the safety and tolerability of ABP1618 tablets in patients with advanced solid tumors; to determine the recommended dose (RP2D) and dosing regimen for subsequent clinical trials.
2. Secondary Objectives
To study the pharmacokinetic (PK) characteristics of single and multiple doses of ABP1618 tablets in patients with advanced solid tumors;
To preliminarily evaluate the cardiac safety of ABP1618 tablets, including the possibility of correcting QT interval (QTc) prolongation, and to evaluate the PK/QTc relationship;
To preliminarily evaluate the effectiveness of ABP1618 tablets in the treatment of advanced solid tumors.
(II) Objectives of Phase II Study
1. Primary Objectives
To preliminarily evaluate the effectiveness of ABP1618 tablets in target patients with advanced solid tumors.
2. Secondary Objectives
To evaluate the safety of ABP1618 tablets in target patients with advanced solid tumors.