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

May 14, 2026 updated by: Jennerex Biotherapeutics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Busan, South Korea, 602-715
        • Dong-A University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
1e8 pfu (plaque forming units)total dose each treatment day
Genetic: 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.
Experimental: 2
3e8 pfu (plaque forming units) total dose each treatment day
Genetic: 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.
Experimental: 3
1e9 pfu (plaque forming units) total dose each treatment day
Genetic: 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.
Experimental: 4
3e9 pfu (plaque forming units) total dose each treatment day
Genetic: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Safety evaluation throughout study participation

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Throughout the study participation, up to 1 year post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jennerex Biotherapeutics

Collaborators

Green Cross Corporation

Investigators

  • Study Director: David Kirn, MD, Jennerex Biotherapeutics (Jennerex, Inc.)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

February 26, 2008

First Submitted That Met QC Criteria

February 26, 2008

First Posted (Estimated)

March 6, 2008

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JX594-IT-HEP001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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