A Prospective, Exploratory Study to Evaluate the Safety and Efficacy of the Combination of ABSK-011 and ABSK043 in Patients With Previously Treated Unresectable or Metastatic Hepatocellular Carcinoma With FGF19 Overexpression
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To evaluate the objective response rate of ABSK-011 plus ABSK043 in patients with previously treated unresectable or metastatic HCC harboring FGF19 overexpression
研究概览
简要总结
This study is designed prospectively to investigate the safety and efficacy of ABSK-011 and ABSK043 in patients with previously treated unresectable or metastatic hepatocellular carcinoma (HCC) harboring FGF19 overexpression. ABSK-011, an oral, selective FGFR4 inhibitor which can irreversibly bind to the target. ABSK043, is an orally available, selective and potent inhibitor targeting the interaction of PD-1 and PD-L1, Safety, tolerability, and preliminary efficacy of ABSK-011 or ABSK043 were explored in a phase 1 trial ABSK-011-101 (NCT04906434) and ABSK043-101 (NCT04964375) trial, respectively. This trial focuses on the efficacy of the combination of ABSK-011 and ABSK043 in patients with previously treated unresectable or metastatic HCC harboring FGF19 overexpression.
详细描述
The patients that meet the Inclusion and Exclusion Criteria will treat with ABSK-011 RP2D and ABSK043 RP2D until the disease progression
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with HCC confirmed by pathological histology or cytology, or meeting the clinical diagnostic criteria for HCC as the AASLD or Guidelines for the diagnosis and treatment of primary liver cancer (China).
- •Progression of disease confirmed by imaging after receiving at least one line of systemic therapy
- •The central laboratory test report for FGF19 overexpression positive.
- •ECOG performance status of 0 or 1;
- •Adequate organ and marrow function defined by study-specified laboratory tests;
排除标准
- •Has received prior therapy with FGFR4 or pan-FGFR inhibitors;
- •Hypersensitivity for any constituent of ABSK-011 or ABSK043;
- •Past or current hepatic encephalopathy; patients with known untreated or inadequately controlled central nervous system metastases that have not been effectively managed with treatment
- •have other malignant tumors that are currently in a progressive stage or require effective treatment
- •Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
研究组 & 干预措施
ABSK-011+ABSK043
干预措施: ABSK-011 (Drug)
结局指标
主要结局
To evaluate the objective response rate of ABSK-011 plus ABSK043 in patients with previously treated unresectable or metastatic HCC harboring FGF19 overexpression
时间窗: 10 months
Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed
次要结局
未报告次要终点