NCT06695026 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
| NCT ID | NCT06695026 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Rznomics, Inc. |
| Condition | Hepatocellular Carcinoma (HCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-12-18 |
| Primary Completion | 2027-08 |
Trial Parameters
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Brief Summary
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.
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
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