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Hepatocellular CarcinomaPhase 1/2NCT05595473

A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 with Valganciclovir (VGCV) 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, run by Rznomics, Inc. at 5 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
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
42 participants
Where
5 sitesSouth Korea
Study dates
29 Jul 2022to May 2029
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 to B7
  • 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

5 sites in 1 country.

5 sites in 1 country

South Korea5 sites

  • Kyungpook National University Hospital

    Deagu, 41944

  • Samsung Medical Center

    Seoul, Seoul, 06351

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

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

    Seoul, 06591

Other trials in South Korea

About this study

Official title: 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

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.

Read the 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.

Being tested
RZ-001 Dose 1, RZ-001 Dose 2, RZ-001 Dose 3, RZ-001 Dose 4
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

  • RZ-001 Dose 2Drug

    RZ-001 Dose 2 and VGCV

  • RZ-001 Dose 3Drug

    RZ-001 Dose 3 and VGCV

  • RZ-001 Dose 4Drug

    RZ-001 Dose 4 and VGCV

Study groups in NCT05595473
Study groupRoleWhat they receive
Cohort 1ExperimentalNot described
Receives: Drug: RZ-001 Dose 1
Cohort 2ExperimentalNot described
Receives: Drug: RZ-001 Dose 2
Cohort 3ExperimentalNot described
Receives: Drug: RZ-001 Dose 3
Cohort 4ExperimentalNot described
Receives: Drug: RZ-001 Dose 4

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Dose limiting toxicities (DLT) in Part 1 as graded by NCI-CTCAE

    Measured: Day 1 to Day 28

  2. To determine safety and efficacy of RZ-001 by changes in overall response rate (ORR) for participants in part 2 as graded by RECIST v1.1 and mRECIST

    Measured: Day 1 to Day 15

  3. To determine safety and efficacy of RZ-001 by changes in duration of response (DOR) in part 2 as graded by RECIST v1.1 and mRECIST

    Measured: Day 1 to Day 15

  4. To determine safety and efficacy of RZ-001 by changes in Progression free survial (PFS) of participants in part 2 as graded by RECIST v1.1 and mRECIST

    Measured: Day 1 to Day 15

  5. To determine safety and efficacy of RZ-001 by changes in overall survival (OS) of participants in part 2 as graded by RECIST v1.1 and mRECIST

    Measured: Day 1 to Day 15

  6. Number of participants with adverse events (AEs) in part 1 and 2 as graded by NCI-CTCAE

    Measured: Day 1 to Day 28

Secondary outcomes (4)

  1. To determine safety and efficacy of RZ-001 by changes in overall response rate (ORR) of the partipants in Part 1 as graded by RECIST v1.1 and mRECIST

    Measured: Day 1 to Day 15

  2. To determine safety and efficacy of RZ-001 by changes in duration of response (DOR) of the partipants in Part 1 as graded by RECIST v1.1 and mRECIST

    Measured: Day 1 to Day 15

  3. To determine safety and efficacy of RZ-001 by changes in Progression free survial (PFS) of the partipants in Part 1 as graded by RECIST v1.1 and mRECIST

    Measured: Day 1 to Day 15

  4. To determine safety and efficacy of RZ-001 by changes in overall survival (OS) of the partipants in Part 1 as graded by RECIST v1.1 and mRECIST

    Measured: Day 1 to Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2022
  2. Study start29 Jul 2022
  3. Primary completionMar 2029 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05595473
Sponsor's protocol ID
RZ-001
Status last verified
Oct 2024
First submitted
7 Sep 2022
Last updated
4 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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, run by Rznomics, Inc. at 5 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Dose limiting toxicities (DLT) in Part 1 as graded by NCI-CTCAE (time frame: Day 1 to Day 28). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05595473.

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 4 Nov 2024.

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