A Phase 1 Study of ALN-BCAT as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 158
- 试验地点
- 24
- 主要终点
- Frequency of Adverse Events (AEs)
研究概览
简要总结
The purpose of the dose escalation part of the study is to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as monotherapy and in combination with pembrolizumab. The purpose of the dose expansion part of the of the study is to evaluate the antitumor activity of ALN-BCAT as monotherapy and in combination with pembrolizumab; to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Has HCC confirmed histologically or cytologically, or, for patients with liver cirrhosis, clinically by the American Association for the Study of Liver Diseases (AASLD) criteria
- •Has had at least one line of systemic therapy for unresectable advanced or metastatic disease
- •Has at least one wingless-related integration site (WNT)-pathway activating mutation
- •Child-Pugh class A or B7
排除标准
- •Has fibrolamellar HCC, sarcomatoid HCC, or mixed cholangio-HCC tumors
- •Has symptomatic extrahepatic disease
- •Has received anti-cancer therapy or investigational drugs ≤3 weeks prior to the first dose of study drug
- •Note: other protocol defined inclusion / exclusion criteria apply
研究组 & 干预措施
Combination Therapy: Dose Expansion
Patients will be administered multiple doses of ALN-BCAT in combination with pembrolizumab.
干预措施: ALN-BCAT (Drug)
Monotherapy: Dose Escalation
Patients will be administered multiple doses of ALN-BCAT.
干预措施: ALN-BCAT (Drug)
Combination Therapy: Dose Expansion
Patients will be administered multiple doses of ALN-BCAT in combination with pembrolizumab.
干预措施: Pembrolizumab (Drug)
Combination Therapy: Dose Escalation
Patients will be administered multiple doses of ALN-BCAT in combination with pembrolizumab.
干预措施: ALN-BCAT (Drug)
Combination Therapy: Dose Escalation
Patients will be administered multiple doses of ALN-BCAT in combination with pembrolizumab.
干预措施: Pembrolizumab (Drug)
Monotherapy: Dose Expansion
Patients will be administered multiple doses of ALN-BCAT.
干预措施: ALN-BCAT (Drug)
结局指标
主要结局
Frequency of Adverse Events (AEs)
时间窗: From the time of first dose of study drug administration to 30-37 days after the last dose
Severity of AEs
时间窗: From the time of first dose of study drug administration to 30-37 days after the last dose
Dose Escalation: Occurrence of Dose-limiting Toxicities (DLTs)
时间窗: From the time of first dose of study drug administration up to 21 days
Dose Expansion: Antitumor Activity as assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
时间窗: Up to 30-37 Days after the last dose
次要结局
- Concentrations of ALN-BCAT in Plasma(Up to the end of the last study drug administration)
- Percent Change in Gene that Encodes ß-catenin Protein (CTNNB1) Messenger Ribonucleic Acid (mRNA) Expression Comparing Pre- treatment with On-treatment Tumor Samples(Up to 30 days)
- Dose Escalation: Antitumor Activity as assessed by RECIST v1.1(Up to 30-37 Days after the last dose)