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A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 With Valganciclovir (VGCV) in Subjects With Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

The study will be conducted in 2 parts. Part 1 is a dose escalation study which aims to explore the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) after the single escalating dose of the intratumoral (IT) injection given through 4 different cohorts. Part 2 will consist of dose expansion, exploring clinical activity for the optimal fixed dose based on the results of Part 1. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05595473
Study type Interventional
Source Rznomics, Inc.
Contact Rznomics Inc.
Phone +82317068730
Email rznomics@rznomics.com
Status Recruiting
Phase Phase 1/Phase 2
Start date July 29, 2022
Completion date May 2029
View Details
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