Overview
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.
Description
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).
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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