A Phase 1b/2a, Open-label, Multicenter, Randomized, Dose Escalation Study Evaluating the Safety, Tolerability and Efficacy of RZ-001 in Combination With Valganciclovir and Atezolizumab/Bevacizumab in Subjects With Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 9
- 主要终点
- Number of participants with adverse events (AEs) as graded by NCI CTCAE
研究概览
简要总结
This study is to evaluate the safety, tolerability, efficacy and immunogenicity of RZ-001 in combination with Valganciclovir (VGCV) and Atezolizumab/Bevacizumab when given to subjects with human telomerase reverse transcriptase (hTERT)-positive HCC.
详细描述
15 subjects will be enrolled in each of the 3 cohorts. Once enrollment of the first 3 of 15 subjects is completed, Safety and Efficacy Review Committee (SERC) meeting involving the study Investigators and the Sponsor's clinical study team will be held after Day 43 (Week 6) visit of the third subject enrolled. After the data from enrolled subjects is reviewed in the meeting, dose escalation to the next dose will be determined, based on the number of subjects experiencing dose-limiting toxicity (DLT).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •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
o Interventions:
Drug: RZ-001 Dose 1
干预措施: RZ-001 Dose 1 (Drug)
Cohort 2
o Interventions: Drug: RZ-001 Dose 2
干预措施: RZ-001 Dose 2 (Drug)
Cohort 3
o Interventions: Drug: RZ-001 Dose 3
干预措施: RZ-001 Dose 3 (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs) as graded by NCI CTCAE
时间窗: Screening visit, up to 2 years
Assessment of tumor response of target lesion where RZ-001 is administered based on the RECIST v1.1 and HCC mRECIST
时间窗: Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years
Overall response rate based on RECIST v1.1 and HCC mRECIST
时间窗: Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years
次要结局
- Assessment of tumor response of non-target lesions, besides the target lesion where RZ-001 is administered based on the RECIST v1.1 and HCC mRECIST(Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years)
- Progression-free survival (PFS)(Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years)
- Overall survival (OS)(Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years)
- Duration of response (DOR)(Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years)