A Phase 1/2a, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability and Efficacy of RZ-001 in Combination with Valganciclovir in Subjects with Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 5
- 主要终点
- Number of participants with Dose limiting toxicities (DLT) in Part 1 as graded by NCI-CTCAE
研究概览
简要总结
This is first in human study to evaluate the safety, tolerability, immunogenicity, and preliminary clinical activity of RZ-001 when given to subjects with human telomerase reverse transcriptase (hTERT)-positive HCC.
详细描述
The study will be conducted in 2 parts.
Part 1 is a dose escalation study which aims to explore the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) after the single escalating dose of the intratumoral (IT) injection given through 4 different cohorts.
Part 2 will consist of dose expansion, exploring clinical activity for the optimal fixed dose based on the results of Part 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Adult males and females
- •Hepatocellular carcinoma diagnosis (BCLC stage B or C)
- •hTERT positive expression confirmed during the screening period
- •ECOG score of 0 or 1
- •Child-Pugh score of A to B7
- •Life expectancy >= 3 months
排除标准
- •Moderate or severe ascites
- •History of hepatic encephalopathy
- •Carcinomas other than HCC
- •Current or history of HIV positive
- •Not suitable for inclusion judged by the investigator
研究组 & 干预措施
Cohort 1
干预措施: RZ-001 Dose 1 (Drug)
Cohort 2
干预措施: RZ-001 Dose 2 (Drug)
Cohort 3
干预措施: RZ-001 Dose 3 (Drug)
Cohort 4
干预措施: RZ-001 Dose 4 (Drug)
结局指标
主要结局
Number of participants with Dose limiting toxicities (DLT) in Part 1 as graded by NCI-CTCAE
时间窗: Day 1 to Day 28
To determine safety and efficacy of RZ-001 by changes in overall response rate (ORR) for participants in part 2 as graded by RECIST v1.1 and mRECIST
时间窗: Day 1 to Day 15
To determine safety and efficacy of RZ-001 by changes in duration of response (DOR) in part 2 as graded by RECIST v1.1 and mRECIST
时间窗: Day 1 to Day 15
To determine safety and efficacy of RZ-001 by changes in Progression free survial (PFS) of participants in part 2 as graded by RECIST v1.1 and mRECIST
时间窗: Day 1 to Day 15
To determine safety and efficacy of RZ-001 by changes in overall survival (OS) of participants in part 2 as graded by RECIST v1.1 and mRECIST
时间窗: Day 1 to Day 15
Number of participants with adverse events (AEs) in part 1 and 2 as graded by NCI-CTCAE
时间窗: Day 1 to Day 28
次要结局
- To determine safety and efficacy of RZ-001 by changes in overall response rate (ORR) of the partipants in Part 1 as graded by RECIST v1.1 and mRECIST(Day 1 to Day 15)
- To determine safety and efficacy of RZ-001 by changes in duration of response (DOR) of the partipants in Part 1 as graded by RECIST v1.1 and mRECIST(Day 1 to Day 15)
- To determine safety and efficacy of RZ-001 by changes in Progression free survial (PFS) of the partipants in Part 1 as graded by RECIST v1.1 and mRECIST(Day 1 to Day 15)
- To determine safety and efficacy of RZ-001 by changes in overall survival (OS) of the partipants in Part 1 as graded by RECIST v1.1 and mRECIST(Day 1 to Day 15)