A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 with Valganciclovir (VGCV) in Subjects with Hepatocellular Carcinoma
NCT05595473 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2024-11-04
Summary
This is first in human study to evaluate the safety, tolerability, immunogenicity, and preliminary clinical activity of RZ-001 when given to subjects with human telomerase reverse transcriptase (hTERT)-positive HCC.
Conditions
Interventions
- DRUG
-
RZ-001 Dose 1
RZ-001 Dose 1 and VGCV
- DRUG
-
RZ-001 Dose 2
RZ-001 Dose 2 and VGCV
- DRUG
-
RZ-001 Dose 3
RZ-001 Dose 3 and VGCV
- DRUG
-
RZ-001 Dose 4
RZ-001 Dose 4 and VGCV
Sponsors & Collaborators
-
Rznomics, Inc.
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-29
- Primary Completion
- 2029-03-31
- Completion
- 2029-05-31
- FDA Drug
- Yes
Countries
- South Korea
Study Locations
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