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

• Status: Recruiting
• Trial end date: 2029-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rznomics, Inc.

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 to B7

• 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