RecruitingPhase 1Phase 2NCT06695026

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


Sponsor

Rznomics, Inc.

Enrollment

45 participants

Start Date

Dec 18, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental treatment called RZ-001 in combination with two existing drugs (valganciclovir and atezolizumab/bevacizumab) for patients with hepatocellular carcinoma (primary liver cancer) at an intermediate to advanced stage. RZ-001 is a cancer vaccine approach that targets a protein called hTERT, which is overexpressed in many cancers. **You may be eligible if...** - You are an adult (male or female) - You have been diagnosed with hepatocellular carcinoma at BCLC stage B or C (intermediate or advanced) - Your tumor tests positive for the hTERT protein - Your performance status is 0 or 1 (able to carry out daily activities with little or no restriction) - Your liver function is well-preserved (Child-Pugh score A) - Your life expectancy is at least 3 months **You may NOT be eligible if...** - You have moderate or severe fluid buildup in your abdomen (ascites) - You have a history of hepatic encephalopathy (brain dysfunction related to liver disease) - You have other types of cancer besides HCC - You are HIV-positive - Your doctor does not consider you suitable for the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRZ-001 Dose 1

RZ-001 Dose 1 and VGCV, Atezolizumab/Bevacizumab

DRUGRZ-001 Dose 2

RZ-001 Dose 2 and VGCV, Atezolizumab/Bevacizumab

DRUGRZ-001 Dose 3

RZ-001 Dose 3 and VGCV, Atezolizumab/Bevacizumab


Locations(9)

Pusan National University Yangsan Hospital

Busan, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Kangbuk Samsung Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06695026


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