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

NCT ID: NCT06695026

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-18

Study Completion Date

2027-10-31

Brief Summary

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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.

Detailed Description

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15 subjects will be enrolled in each of the 3 cohorts. Once enrollment of the first 3 of 15 subjects is completed, Safety and Efficacy Review Committee (SERC) meeting involving the study Investigators and the Sponsor's clinical study team will be held after Day 43 (Week 6) visit of the third subject enrolled. After the data from enrolled subjects is reviewed in the meeting, dose escalation to the next dose will be determined, based on the number of subjects experiencing dose-limiting toxicity (DLT).

Conditions

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Hepatocellular Carcinoma (HCC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

o Interventions:

Drug: RZ-001 Dose 1

Group Type EXPERIMENTAL

RZ-001 Dose 1

Intervention Type DRUG

RZ-001 Dose 1 and VGCV, Atezolizumab/Bevacizumab

Cohort 2

o Interventions: Drug: RZ-001 Dose 2

Group Type EXPERIMENTAL

RZ-001 Dose 2

Intervention Type DRUG

RZ-001 Dose 2 and VGCV, Atezolizumab/Bevacizumab

Cohort 3

o Interventions: Drug: RZ-001 Dose 3

Group Type EXPERIMENTAL

RZ-001 Dose 3

Intervention Type DRUG

RZ-001 Dose 3 and VGCV, Atezolizumab/Bevacizumab

Interventions

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RZ-001 Dose 1

RZ-001 Dose 1 and VGCV, Atezolizumab/Bevacizumab

Intervention Type DRUG

RZ-001 Dose 2

RZ-001 Dose 2 and VGCV, Atezolizumab/Bevacizumab

Intervention Type DRUG

RZ-001 Dose 3

RZ-001 Dose 3 and VGCV, Atezolizumab/Bevacizumab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rznomics, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pusan National University Yangsan Hospital

Busan, , South Korea

Site Status RECRUITING

Kyungpook National University Hospital

Daegu, , South Korea

Site Status RECRUITING

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

Seoul, , South Korea

Site Status RECRUITING

Gangnam Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Kangbuk Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Rznomics, Inc.

Role: CONTACT

+82-31-706-8730

Other Identifiers

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RZ-001-102

Identifier Type: -

Identifier Source: org_study_id

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