Clinical trial Recruiting at 9 sites Phase1; Phase2 Interventional Ages 18 and up

Evaluating RZ-001 with Valganciclovir and Atezolizumab/Bevacizumab for Liver Cancer

Official title: 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

Run by Rznomics, Inc. · NCT06695026 · Data updated 2026-11-12

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.

More Hepatocellular Carcinoma (HCC) trials

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment45 (estimated)
SponsorRznomics, Inc.
Academic / other
Drugs / interventionsAtezolizumab, Bevacizumab
Locations9 sites (Busan and 8 other locations)
StatusRecruiting
StartedDecember 18, 2024
Main results expectedAugust 2027
Study endsOctober 2027
Registry record updatedJuly 29, 2025
Trial IDNCT06695026 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients with moderate to severe ascites, history of hepatic encephalopathy, or other carcinomas may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While this approach is novel, similar studies combining immunotherapy with targeted therapies have shown promise in other cancer types.

Who can join: the full rules

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 it's running

  • 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
Show 3 more locations
  • Samsung Medical Center
    Seoul, South Korea
    Recruiting
  • Seoul National University Hospital
    Seoul, South Korea
    Recruiting
  • Severance Hospital
    Seoul, South Korea
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.