NCT05595473

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Rznomics, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-07-29
• Primary completion: 2029-03-01
• Completion: 2029-05-01
• First posted: 2022-10-27
• Last updated: 2024-11-04

Locations

5 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study