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Head and Neck CancerPhase 1GX-051NCT02079324

Genetically Modified Mesenchymal Stem Cell Theraopeutic Against Head and Neck Cancer

A Phase 1 study testing GX-051 in people with Head and Neck Cancer, run by Genexine, Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research is to evaluate MTD, Safety and efficacy of GX-051 after intratumoral injection in head and neck cancer patience. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
GX-051
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSouth Korea
Study dates
Mar 2014to Sep 2016
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Are capable of understanding and complying with the requirements of the study and have signed the informed consent from (ICF).
  • Very advanced head and neck cancer aged more than 19.
  • Longest distance of the tumor is bigger than 1 cm and capable of Intratumoral injection.
  • Baseline ECOG Performance Status 0, 1 or 2.
  • Have a life expectancy more than 6 months.

Who cannot join

  • Have no history of prior anticancer treatment.
  • Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.Subject who have participated in a clinical trial of an treatment vaccine or immunotherapy in an year.
  • Have a tumor which is near a main vessel that can be occured embolism after injection or which has hypervascularity.
  • Patients currently receiving anticancer immuno-therapies Patients who have received prior treatment with an stem cell therapy.
  • Have autoimmune disease (multiple sclerosis, systemic lupus erythromatosis, thyroiditis, psoriasis, inflammatory bowel diseases etc.).
  • Have Graft rejection reaction such as GVHD.
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  • Have immunodeficiency disease.
  • Leukocytes< 3.0 x109/L.
  • Absolute neutrophil count < 1.5x109/L.
  • Platelet count < 100 x 109/L.
  • Have known positive test for hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV).
  • Alanine Aminotransferase (ALT) > 2.5xUNL.
  • Aspartate Aminotransferase (AST)> 2.5xUNL.
  • Total Bilirubin> UNL.
  • Have blood Creatinine> UNL.
  • Known allergy to IL-12 or the excipient(s) of the study medication including fetal bovine serum.
  • Second primary cancer Metastatic brain tumor or meningioma.
  • Have a tumor near a main artery.
  • Uncontrolled hypertension.
  • Uncontrolled diabetes uncontrolled (arrhythmia).
  • Heart failure (more than NYHA Functional Class II); unstable coronary artery disease; myocardial infarction within 6 months.
  • Child-Pugh Class C hepatic impairment.
  • Severe renal impairment (creatinine clearance < 30 ml/min) or on dialysis.
  • Have active infection or history of recurrent infection.
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
  • Are considered ineligible by the investigator due to a mental disease or CNS disease.
  • Administration of any other tumor therapy, including chemotherapy and radiotherapy within 4 weeks(6 weeks in case of nitrosoureas and mytomycin C) before the beginning of study treatment.
  • Patients receiving chronic, systemic treatment with immunosuppressive agent(steroid) or immuno-modulator within 2 weeks prior to screening.
  • Have participated in another clinical trial within 30 days prior to dosing.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

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

    Seoul, 137-701

Other trials in South Korea

About this study

Official title: A Single Center, Open-Label, Accelerated Titration, Dose-Escalating, Phase Ι Study to Evaluate the Safety and Tolerability of IT Injection GX-051, Stem Cell Based Gene Therapeutics in Patients With Very Advanced Head and Neck Cancer

The purpose of this research is to evaluate MTD, Safety and efficacy of GX-051 after intratumoral injection in head and neck cancer patience.

Read the detailed description

The primary purpose of the study is to determine MTD(Maximum Tolerable Dose) of GX-051 administered in tumor. The second purpose is to evaluate safety and efficacy of GX-051.

Being tested
GX-051
Keywords
head and neck cancer, gene therapy, stem cell therapy, immunotherappy
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GX-051Biological

    intratumoral injection

Study groups in NCT02079324
Study groupRoleWhat they receive
GX-051ExperimentalGX-051 intratumoral injection
Receives: Biological: GX-051

What is being measured

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

  1. MTD after GX-051 intratumoral injection

    Measured: 2 months

Secondary outcomes (6)

  1. Adverse events after GX-051 intratumoral injection

    Measured: 2 months

  2. Anti-tumor response by RECIST 1.1 on computed tomography

    Response Evaluation Criteria in Solid Tumors (RECIST) are used to determine objective clinical response. Complete Rresponse (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% decrease in the target lesions, progressive disease (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

    Measured: 2 months

  3. Changes of INF-γ and IL-12 levels in blood comparing to the baseline after GX-051 intratumoral injection

    unit: pg/ml

    Measured: 2 months

  4. Changes of immune cell distribution in tumor tissue after GX-051 intratumoral injection

    We will analyze immune cells such as CD4+ T cell, CD8+ T cell, NK cell by FACS analysis on day 1(baseline), day 29(end of treatment) and day 57(follow up)

    Measured: 2 months

  5. Evaluation of antibody generation against IL-12 which is active ingredient of GX-051

    We will analyze anti-IL-12 antibody in blood by ELISA on the screening visit and the follw up visit. Result will report as existence or absence of the anti-body .

    Measured: 2 months

  6. Evaluation of long term safety examined by vital sign, physical examination, clinical laboratory tests, CT etc

    Safety profile would be examined by vital sign, physical examination, clinical laboratory tests, CT etc

    Measured: 17 monthes

Timeline

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

  1. First posted5 Mar 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionSep 2016
  4. Study completionSep 2016

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02079324
Sponsor's protocol ID
GX-051_HNC_1
Acronym
GX-051
Status last verified
Mar 2014
First submitted
27 Feb 2014
Last updated
22 Aug 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GX-051 in people with Head and Neck Cancer, run by Genexine, Inc. 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 5 inclusion and 29 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 22 Aug 2025. 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?

MTD after GX-051 intratumoral injection (time frame: 2 months). 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 NCT02079324.

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 22 Aug 2025.

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