Neoplasms, LiverPhase 1NCT00629759
A Study of Recombinant Vaccinia Virus to Evaluate the Safety and Efficacy of a Transdermal Injection Within the Tumor of Patients With Primary or Metastatic Hepatic Carcinoma
A Phase 1 study testing JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF) in people with Neoplasms, Liver, run by Jennerex Biotherapeutics at 1 site in South Korea.
Trial summary
The primary purpose of this study is to determine the maximum tolerable dose (MTD) and/or the maximum feasible dose (MFD), as well as to evaluate the safety of JX-594 (Pexa-Vec) injected within hepatic carcinoma tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Liver
- What is being tested?
- JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2006to Aug 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years
- Patients with hepatic carcinoma (primary or metastatic) clinically or histologically confirmed to have tumors (≤10cm maximum diameter) that are progressing (refractory to standard treatment) despite regular treatment and that can be transdermally accessed by an injection needle in an imaging-guided procedure
- Tumor progression despite undergoing regular treatment such as surgery, transarterial chemoembolization, chemotherapy, and radiotherapy
- Performance score: Karnofsky Performance Score (KPS) ≥70
- Expected survival of at least 16 weeks
- For patients who are sexually active, able and willing to use contraceptives for a three month period during and after taking JX-594
Show all 16Show fewer
- WBC > 3,500 cells/mm3
- ANC > 1,500 cells/mm3
- Hemoglobin > 10g/dL
- Platelet count > 75,000 plts/mm3
- Serum creatinine < 1.5 mg/dL
- AST, ALT < 2.5 x ULN
- Total bilirubin ≤ 2.0 mg/dL
- In patients with primary HCC, Child Pugh A or B
- Able/willing to sign an IRB/IEC/REB-approved written consent form
- Able and willing to comply with study procedures and follow-up examinations
Who cannot join
- Pregnant or nursing an infant
- Known infection with HIV
- Clinically significant active infection or uncontrolled medical condition considered high risk for investigational new drug treatment
- Significant immunodeficiency due to underlying illness (e.g. hematological malignancies, congenital immunodeficiencies and/or HIV infection/AIDS) and/or medication (e.g. high-dose systemic corticosteroids)
- Patients with household contacts with significant immunodeficiency
- History of exfoliative skin condition (e.g. severe eczema, ectopic dermatitis, or similar skin disorder) that at some stage has required systemic therapy
- Severe or unstable cardiac disease
- Use of adrenal cortical hormone drug or immunosuppressant within four weeks of study enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Clinical Study for Evaluating the Safety and Efficacy of a Transdermal Injection of JX-594 (Thymidine Kinase (-)/GM-CSF(+) Vaccinia Virus) Within the Tumor of Patients With Hepatic Carcinoma
The primary purpose of this study is to determine the maximum tolerable dose (MTD) and/or the maximum feasible dose (MFD), as well as to evaluate the safety of JX-594 (Pexa-Vec) injected within hepatic carcinoma tumors.
Read the detailed description
Patients are treated with JX-594 once every three weeks until progression at the site(s) of injection or until the patient has received a maximum of 4 treatments; four additional cycles can be administered to patients with an objective response of the injected tumor(s) (i.e. 8 total treatments possible). Study dose levels are 1e8 pfu, 3e8 pfu, 1e9 pfu and 3e9 pfu per treatment. Standard Phase I dose-escalation guidelines are used, with 2-6 patients enrolled per cohort (3 if no dose-limiting toxicities are reported).
- Conditions
- Neoplasms, Liver
- Being tested
- JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)
- Keywords
- Jennerex, unresectable liver tumors, primary liver cancer, metastatic liver cancer, oncolytic virus, vaccinia virus, Pexa-Vec
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular, Vaccinia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)Genetic
The total dose is divided between 1-3 tumors located within the liver. Patients are treated with JX-594 once every 3 weeks until progression at the site(s) of injection or until the patient has received a maximum of 4 treatments.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 1e8 pfu (plaque forming units)total dose each treatment day Receives: Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF) |
| 2 | Experimental | 3e8 pfu (plaque forming units) total dose each treatment day Receives: Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF) |
| 3 | Experimental | 1e9 pfu (plaque forming units) total dose each treatment day Receives: Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF) |
| 4 | Experimental | 3e9 pfu (plaque forming units) total dose each treatment day Receives: Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerable dose (MTD) and/or the maximum feasible dose (MFD), as well as to evaluate the safety of JX-594 injected within unresectable solid tumor(s) within the liver
Measured: Safety evaluation throughout study participation
Secondary outcomes (1)
Secondary objectives include determination of JX-594 pharmacokinetics, replication and shedding, immune response, and injection site tumor responses.
Measured: Throughout the study participation, up to 1 year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startJan 2006
- Primary completionJul 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasms, LiverStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennerex Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Green Cross Corporation
- Responsible party
- Sponsor
- Investigators
- David Kirn, MD, Study director, Jennerex Biotherapeutics (Jennerex, Inc.)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629759
- Sponsor's protocol ID
- JX594-IT-HEP001
- Status last verified
- May 2026
- First submitted
- 26 Feb 2008
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park BH, Hwang T, Liu TC, Sze DY, Kim JS, Kwon HC, Oh SY, Han SY, Yoon JH, Hong SH, Moon A, Speth K, Park C, Ahn YJ, Daneshmand M, Rhee BG, Pinedo HM, Bell JC, Kirn DH. Use of a targeted oncolytic poxvirus, JX-594, in patients with refractory primary or metastatic liver cancer: a phase I trial. Lancet Oncol. 2008 Jun;9(6):533-42. doi: 10.1016/S1470-2045(08)70107-4. Epub 2008 May 19.
PubMed 18495536
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Study for Evaluating the Safety and Efficacy of a Transdermal Injection of JX-594 (Thymidine Kinase (-)/GM-CSF(+) Vaccinia Virus) Within the Tumor of Patients With Hepatic Carcinoma
- ClinicalTrials.gov ID
- NCT00629759
- Acronym / sponsor ID
- JX594-IT-HEP001
- Conditions
- Neoplasms, Liver
- Keywords
- Jennerex, unresectable liver tumors, primary liver cancer, metastatic liver cancer, oncolytic virus, vaccinia virus, Pexa-Vec
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Jennerex BiotherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Green Cross Corporation
- Study start
- Jan 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 6 Mar 2008 (estimated)
- 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.
The primary purpose of this study is to determine the maximum tolerable dose (MTD) and/or the maximum feasible dose (MFD), as well as to evaluate the safety of JX-594 (Pexa-Vec) injected within hepatic carcinoma tumors.
Detailed description
Patients are treated with JX-594 once every three weeks until progression at the site(s) of injection or until the patient has received a maximum of 4 treatments; four additional cycles can be administered to patients with an objective response of the injected tumor(s) (i.e. 8 total treatments possible). Study dose levels are 1e8 pfu, 3e8 pfu, 1e9 pfu and 3e9 pfu per treatment. Standard Phase I dose-escalation guidelines are used, with 2-6 patients enrolled per cohort (3 if no dose-limiting toxicities are reported).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)1e8 pfu (plaque forming units)total dose each treatment day |
| 2 | Experimental | Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)3e8 pfu (plaque forming units) total dose each treatment day |
| 3 | Experimental | Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)1e9 pfu (plaque forming units) total dose each treatment day |
| 4 | Experimental | Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)3e9 pfu (plaque forming units) total dose each treatment day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years
- Patients with hepatic carcinoma (primary or metastatic) clinically or histologically confirmed to have tumors (≤10cm maximum diameter) that are progressing (refractory to standard treatment) despite regular treatment and that can be transdermally accessed by an injection needle in an imaging-guided procedure
- Tumor progression despite undergoing regular treatment such as surgery, transarterial chemoembolization, chemotherapy, and radiotherapy
- Performance score: Karnofsky Performance Score (KPS) ≥70
- Expected survival of at least 16 weeks
Key exclusion criteria (8 listed)
- Pregnant or nursing an infant
- Known infection with HIV
- Clinically significant active infection or uncontrolled medical condition considered high risk for investigational new drug treatment
- Significant immunodeficiency due to underlying illness (e.g. hematological malignancies, congenital immunodeficiencies and/or HIV infection/AIDS) and/or medication (e.g. high-dose systemic corticosteroids)
- Patients with household contacts with significant immunodeficiency
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 |
|---|---|---|
| JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)The total dose is divided between 1-3 tumors located within the liver. Patients are treated with JX-594 once every 3 weeks until progression at the site(s) of injection or until the patient has received a maximum of 4 treatments. | Genetic | 1, 2, 3, 4 |
Primary outcome
To determine the maximum tolerable dose (MTD) and/or the maximum feasible dose (MFD), as well as to evaluate the safety of JX-594 injected within unresectable solid tumor(s) within the liver
Time frame: Safety evaluation throughout study participation
1 secondary outcome
Secondary objectives include determination of JX-594 pharmacokinetics, replication and shedding, immune response, and injection site tumor responses.
Time frame: Throughout the study participation, up to 1 year post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Derived from this study: PubMed 18495536Park BH, Hwang T, Liu TC, Sze DY, Kim JS, Kwon HC, Oh SY, Han SY, Yoon JH, Hong SH, Moon A, Speth K, Park C, Ahn YJ, Daneshmand M, Rhee BG, Pinedo HM, Bell JC, Kirn DH. Use of a targeted oncolytic poxvirus, JX-594, in patients with refractory primary or metastatic liver cancer: a phase I trial. Lancet Oncol. 2008 Jun;9(6):533-42. doi: 10.1016/S1470-2045(08)70107-4. Epub 2008 May 19.
- Sponsor company websiteLink provided by the sponsor.
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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. This study is not recruiting at the moment.
David Kirn, MD study director
Jennerex Biotherapeutics (Jennerex, Inc.)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF) in people with Neoplasms, Liver, run by Jennerex Biotherapeutics at 1 site 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 16 inclusion and 8 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: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the maximum tolerable dose (MTD) and/or the maximum feasible dose (MFD), as well as to evaluate the safety of JX-594 injected within unresectable solid tumor(s) within the liver (time frame: Safety evaluation throughout study participation). 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 NCT00629759, which also lists 1 linked publication.
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 19 May 2026.