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

Hepatocellular Carcinoma (HCC)

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

Inclusion Criteria6

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 Criteria5

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

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

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NCT06695026

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