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NCT Number: NCT06695026

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

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.

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Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Pusan National University Yangsan Hospital, Busan, South Korea

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RZ-001 Dose 1

Drug

RZ-001 Dose 1 and VGCV, Atezolizumab/Bevacizumab

RZ-001 Dose 2

Drug

RZ-001 Dose 2 and VGCV, Atezolizumab/Bevacizumab

RZ-001 Dose 3

Drug

RZ-001 Dose 3 and VGCV, Atezolizumab/Bevacizumab

Primary outcomes

  1. Number of participants with adverse events (AEs) as graded by NCI CTCAE

    Time frame: Screening visit, up to 2 years

  2. Assessment of tumor response of target lesion where RZ-001 is administered based on the RECIST v1.1 and HCC mRECIST

    Time frame: 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

  3. Overall response rate based on RECIST v1.1 and HCC mRECIST

    Time frame: 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 outcomes

  1. 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

    Time frame: 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

  2. Progression-free survival (PFS)

    Time frame: 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

  3. Overall survival (OS)

    Time frame: 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

  4. Duration of response (DOR)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Rznomics, Inc.

CONTACT

[email protected]

+82-31-706-8730

Sponsors and collaborators

Lead sponsor

Rznomics, Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 19, 2024
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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