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A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 with Valganciclovir (VGCV) in Subjects with Hepatocellular Carcinoma
Sponsor: Rznomics, Inc.
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.
Official title: A Phase 1/2a, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability and Efficacy of RZ-001 in Combination with Valganciclovir in Subjects with Hepatocellular Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2022-07-29
Completion Date
2029-05
Last Updated
2024-11-04
Healthy Volunteers
No
Conditions
Interventions
RZ-001 Dose 1
RZ-001 Dose 1 and VGCV
RZ-001 Dose 2
RZ-001 Dose 2 and VGCV
RZ-001 Dose 3
RZ-001 Dose 3 and VGCV
RZ-001 Dose 4
RZ-001 Dose 4 and VGCV
Locations (5)
Samsung Medical Center
Seoul, Seoul, South Korea
Kyungpook National University Hospital
Deagu, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea