A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 in Combination With Valganciclovir (VGCV) and Atezolizumab/Bevacizumab in Subjects With Hepatocellular Carcinoma

Launched by RZNOMICS, INC. · Nov 15, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with hepatocellular carcinoma (HCC), a type of liver cancer. The study is looking at a combination of three drugs: RZ-001, Valganciclovir (VGCV), and Atezolizumab/Bevacizumab. Researchers want to find out if this combination is safe, how well it works, and how it affects the immune system in patients whose cancer shows a specific marker called hTERT.

To participate in this trial, you need to be an adult (ages 65-74) diagnosed with HCC at a BCLC stage B or C, and your cancer must test positive for hTERT. You should also have a good performance status (ECOG score of 0 or 1) and a Child-Pugh score of A, meaning your liver function is stable. Participants will be monitored closely throughout the study to assess their health and how they respond to the treatment. It's important to know that individuals with certain conditions, such as severe liver issues or other types of cancer, will not be eligible for the trial.

Gender

ALL

Eligibility criteria

• 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