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
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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RECRUITING
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2024-12-18
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
o Interventions:
Drug: RZ-001 Dose 1
RZ-001 Dose 1
RZ-001 Dose 1 and VGCV, Atezolizumab/Bevacizumab
Cohort 2
o Interventions: Drug: RZ-001 Dose 2
RZ-001 Dose 2
RZ-001 Dose 2 and VGCV, Atezolizumab/Bevacizumab
Cohort 3
o Interventions: Drug: RZ-001 Dose 3
RZ-001 Dose 3
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
RZ-001 Dose 2
RZ-001 Dose 2 and VGCV, Atezolizumab/Bevacizumab
RZ-001 Dose 3
RZ-001 Dose 3 and VGCV, Atezolizumab/Bevacizumab
Eligibility Criteria
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Inclusion Criteria
* 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
* History of hepatic encephalopathy
* Carcinomas other than HCC
* Current or history of HIV positive
* Not suitable for inclusion judged by the investigator
18 Years
ALL
No
Sponsors
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Rznomics, Inc.
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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RZ-001-102
Identifier Type: -
Identifier Source: org_study_id
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