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

A Phase 1b/2a, Open-label, Multicenter, Randomized, Dose Escalation Study Evaluating the Safety, Tolerability and Efficacy of RZ-001 in Combination With Valganciclovir and Atezolizumab/Bevacizumab in Subjects With Hepatocellular Carcinoma

This study is to evaluate the safety, tolerability, efficacy and immunogenicity of RZ-001 in combination with Valganciclovir (VGCV) and Atezolizumab/Bevacizumab when given to subjects with human telomerase reverse transcriptase (hTERT)-positive HCC.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma (HCC)
• Intervention / Treatment: Drug: RZ-001 Dose 1; Drug: RZ-001 Dose 2; Drug: RZ-001 Dose 3

Detailed Description

15 subjects will be enrolled in each of the 3 cohorts. Once enrollment of the first 3 of 15 subjects is completed, Safety and Efficacy Review Committee (SERC) meeting involving the study Investigators and the Sponsor's clinical study team will be held after Day 43 (Week 6) visit of the third subject enrolled. After the data from enrolled subjects is reviewed in the meeting, dose escalation to the next dose will be determined, based on the number of subjects experiencing dose-limiting toxicity (DLT).

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Rznomics, Inc.; Phone Number: +82-31-706-8730; Email: rznomics@rznomics.com

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Recruiting
    • Pusan National University Yangsan Hospital
  • Daegu, Korea, Republic of
    • Recruiting
    • Kyungpook National University Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Kangbuk Samsung Medical Center
  • Seoul, Korea, Republic of
    • Recruiting
    • Catholic University of Korea, Seoul ST. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult males and females
• 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:

• Moderate or severe ascites
• History of hepatic encephalopathy
• Carcinomas other than HCC
• Current or history of HIV positive
• Not suitable for inclusion judged by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; o Interventions: Drug: RZ-001 Dose 1	Drug: RZ-001 Dose 1; RZ-001 Dose 1 and VGCV, Atezolizumab/Bevacizumab
Experimental: Cohort 2; o Interventions: Drug: RZ-001 Dose 2	Drug: RZ-001 Dose 2; RZ-001 Dose 2 and VGCV, Atezolizumab/Bevacizumab
Experimental: Cohort 3; o Interventions: Drug: RZ-001 Dose 3	Drug: RZ-001 Dose 3; RZ-001 Dose 3 and VGCV, Atezolizumab/Bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events (AEs) as graded by NCI CTCAE	Screening visit, up to 2 years
Assessment of tumor response of target lesion where RZ-001 is administered based on the RECIST v1.1 and HCC mRECIST	Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years
Overall response rate based on RECIST v1.1 and HCC mRECIST	Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of tumor response of non-target lesions, besides the target lesion where RZ-001 is administered based on the RECIST v1.1 and HCC mRECIST	Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years
Progression-free survival (PFS)	Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years
Overall survival (OS)	Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years
Duration of response (DOR)	Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years

Collaborators and Investigators

• Sponsor: Rznomics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: RZ-001-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes