Clinical trial · Interventional
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
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
NCT06695026CI-TRIAL-00092729recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RZ-001 Dose 1 | Drug | — | UNRESOLVED |
| RZ-001 Dose 2 | Drug | — | UNRESOLVED |
| RZ-001 Dose 3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- o Interventions: Drug: RZ-001 Dose 1
- interventionNames
- Drug: RZ-001 Dose 1
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- o Interventions: Drug: RZ-001 Dose 2
- interventionNames
- Drug: RZ-001 Dose 2
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
- o Interventions: Drug: RZ-001 Dose 3
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.