NCT06695026

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
14mo left

Started Dec 2024

Typical duration for phase_1

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Dec 2024Oct 2027

First Submitted

Initial submission to the registry

November 6, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
29 days until next milestone

Study Start

First participant enrolled

December 18, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

2.6 years

First QC Date

November 6, 2024

Last Update Submit

July 24, 2025

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • 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

Study Arms (3)

Cohort 1

EXPERIMENTAL

o Interventions: Drug: RZ-001 Dose 1

Drug: RZ-001 Dose 1

Cohort 2

EXPERIMENTAL

o Interventions: Drug: RZ-001 Dose 2

Drug: RZ-001 Dose 2

Cohort 3

EXPERIMENTAL

o Interventions: Drug: RZ-001 Dose 3

Drug: RZ-001 Dose 3

Interventions

RZ-001 Dose 1DRUG

RZ-001 Dose 1 and VGCV, Atezolizumab/Bevacizumab

Cohort 1
RZ-001 Dose 2DRUG

RZ-001 Dose 2 and VGCV, Atezolizumab/Bevacizumab

Cohort 2
RZ-001 Dose 3DRUG

RZ-001 Dose 3 and VGCV, Atezolizumab/Bevacizumab

Cohort 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Moderate or severe ascites
  • History of hepatic encephalopathy
  • Carcinomas other than HCC
  • Current or history of HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Pusan National University Yangsan Hospital

Busan, South Korea

RECRUITING

Kyungpook National University Hospital

Daegu, South Korea

RECRUITING

Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

Kangbuk Samsung Medical Center

Seoul, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Rznomics, Inc.

CONTACT

+82-31-706-8730rznomics@rznomics.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2024

First Posted

November 19, 2024

Study Start

December 18, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(9)