Hepatocellular Carcinoma (HCC)Phase 1/2NCT06695026
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 1/2 study testing RZ-001 Dose 1, RZ-001 Dose 2 and RZ-001 Dose 3 in people with Hepatocellular Carcinoma (HCC), run by Rznomics, Inc. at 9 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- RZ-001 Dose 1, RZ-001 Dose 2 and RZ-001 Dose 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 9 sitesSouth Korea
- Study dates
- 18 Dec 2024to Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
South Korea9 sites, 9 recruiting
- Recruiting
Pusan National University Yangsan Hospital
Busan
- Recruiting
Kyungpook National University Hospital
Daegu
- Recruiting
Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
- Recruiting
Gangnam Severance Hospital
Seoul
- Recruiting
Kangbuk Samsung Medical Center
Seoul
- Recruiting
Korea University Guro Hospital
Seoul
- Recruiting
Samsung Medical Center
Seoul
- Recruiting
Seoul National University Hospital
Seoul
- Recruiting
Severance Hospital
Seoul
About this study
Official 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
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.
Read the 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).
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- RZ-001 Dose 1, RZ-001 Dose 2, RZ-001 Dose 3
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RZ-001 Dose 1Drug
RZ-001 Dose 1 and VGCV, Atezolizumab/Bevacizumab
RZ-001 Dose 2Drug
RZ-001 Dose 2 and VGCV, Atezolizumab/Bevacizumab
RZ-001 Dose 3Drug
RZ-001 Dose 3 and VGCV, Atezolizumab/Bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | o Interventions:
Drug: RZ-001 Dose 1 Receives: Drug: RZ-001 Dose 1 |
| Cohort 2 | Experimental | o Interventions: Drug: RZ-001 Dose 2 Receives: Drug: RZ-001 Dose 2 |
| Cohort 3 | Experimental | o Interventions: Drug: RZ-001 Dose 3 Receives: Drug: RZ-001 Dose 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) as graded by NCI CTCAE
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start18 Dec 2024
- Primary completionAug 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rznomics, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695026
- Sponsor's protocol ID
- RZ-001-102
- Status last verified
- Jul 2025
- First submitted
- 6 Nov 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06695026
- Acronym / sponsor ID
- RZ-001-102
- Conditions
- Hepatocellular Carcinoma (HCC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Rznomics, Inc.University, hospital or other
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: RZ-001 Dose 1o Interventions: Drug: RZ-001 Dose 1 |
| Cohort 2 | Experimental | Drug: RZ-001 Dose 2o Interventions: Drug: RZ-001 Dose 2 |
| Cohort 3 | Experimental | Drug: RZ-001 Dose 3o Interventions: Drug: RZ-001 Dose 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RZ-001 Dose 1RZ-001 Dose 1 and VGCV, Atezolizumab/Bevacizumab | Drug | Cohort 1 |
| RZ-001 Dose 2RZ-001 Dose 2 and VGCV, Atezolizumab/Bevacizumab | Drug | Cohort 2 |
| RZ-001 Dose 3RZ-001 Dose 3 and VGCV, Atezolizumab/Bevacizumab | Drug | Cohort 3 |
Primary outcome
Number of participants with adverse events (AEs) as graded by NCI CTCAE
Time frame: 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
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
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
4 secondary outcomes
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma (HCC)
Recruiting
Improving Hepatocellular Carcinoma Screening
Magnetic Resonance Imaging, Hepatocellular Carcinoma
RecruitingObservational study
DNP-MRSI of HCC Metabolism to Predict Therapeutic Response
Barcelona Clinic Liver Cancer (BCLC) Stage A, B or C HCC, Hepatocellular Carcinoma (HCC)
Recruiting
Targeted Navigation in Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma, Cholangiocarcinoma
RecruitingPhase 2/3
A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC
HCC
Active, not recruitingPhase 2
TheraSphere With Durvalumab and Tremelimumab for HCC
Hepatocellular Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RZ-001 Dose 1, RZ-001 Dose 2 and RZ-001 Dose 3 in people with Hepatocellular Carcinoma (HCC), run by Rznomics, Inc. at 9 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rznomics, Inc. (+82-31-706-8730, rznomics@rznomics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) as graded by NCI CTCAE (time frame: Screening visit, up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.