Evaluating RZ-001 with Valganciclovir and Atezolizumab/Bevacizumab for Liver Cancer
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
This study is testing a new combination treatment for advanced liver cancer to see if it is safe and effective for patients with a specific type of the disease.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rznomics, Inc. Academic / other |
| Drugs / interventions | Atezolizumab, Bevacizumab |
| Locations | 9 sites (Busan and 8 other locations) |
| Trial ID | NCT06695026 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, efficacy, and immunogenicity of RZ-001 in combination with Valganciclovir and Atezolizumab/Bevacizumab in patients with hepatocellular carcinoma (HCC) that is positive for human telomerase reverse transcriptase (hTERT). A total of 15 subjects will be enrolled in each of three cohorts, with dose escalation determined by the occurrence of dose-limiting toxicity after a review by a Safety and Efficacy Review Committee. The study aims to assess the potential benefits of this combination therapy in treating advanced liver cancer.
Who should consider this trial
Good fit: Ideal candidates include adults with a diagnosis of hepatocellular carcinoma at BCLC stage B or C, who are hTERT positive and have an ECOG score of 0 or 1.
Not a fit: Patients with moderate to severe ascites, history of hepatic encephalopathy, or other carcinomas may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced hepatocellular carcinoma.
How similar studies have performed: While this approach is novel, similar studies combining immunotherapy with targeted therapies have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Busan and 8 other locations
- Pusan National University Yangsan Hospital — Busan, South Korea (Recruiting)
- Kyungpook National University Hospital — Daegu, South Korea (Recruiting)
- Catholic University of Korea, Seoul St. Mary's Hospital — Seoul, South Korea (Recruiting)
- Gangnam Severance Hospital — Seoul, South Korea (Recruiting)
- Kangbuk Samsung Medical Center — Seoul, South Korea (Recruiting)
- Korea University Guro Hospital — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Severance Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Rznomics, Inc.
- Email: rznomics@rznomics.com
- Phone: +82-31-706-8730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.