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Cervical Intraepithelial NeoplasiaPhase 2NCT02139267

Dose-finding, Safety Study of Plasmid DNA Therapeutic Vaccine to Treat Cervical Intraepithelial Neoplasia

A Phase 2 study testing GX-188E in people with Cervical Intraepithelial Neoplasia, run by Genexine, Inc. at 4 sites 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 study is to determine the optimal dose of GX-188E for the Phase 3 and access the efficacy and safety of GX-188E according the protocol in patients with Cervical Intraepithelial Neoplasia 3 (CIN3). Read more about this study

Who is it for?
Ages 19 to 50 years, women only
Conditions the study is for
Cervical Intraepithelial Neoplasia
What is being tested?
GX-188E
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
4 sitesSouth Korea
Study dates
Jul 2014to Mar 2016
Phase
Phase 2
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 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Voluntarily signed informed consent form after receiving education about this study and the investigational product.
  • Female aged between 19 and 50 years
  • Positive test results for HPV Type 16 and/or Type 18
  • Histopathologically-confirmed Cervical Intraepithelial Neoplasia 3
  • Entire cervical area including entire squamocolumnar junction is visualized through colposcopy
  • Eligible based on screening test results.
  • Promised not to get pregnant throughout the study

Who cannot join

  • Suspected Adenocarcinoma in situ
  • Malignant cancer more than Stage I
  • Pregnancy or breastfeeding
  • Participation in clinical trials within 30 days of the screening visit
  • Administration of immunosuppressant or immunomodulator within 6 months prior to the enrolment
  • Administered with systemic steroid(as a standard with Prednisolone, more than 20mg/day for every 14 days or more) within 3 months of Day 1(including ointment, eye drops, inhalated or nasal, intra-ligamental or intra-articular injection, but not applicable if injected every other day
Show all 23Show fewer
  • Administered any blood products within 3 months prior to the screening visit
  • Administered any vaccine within 4 weeks prior to the screening visit(ex. Hepatitis A, Hepatitis B, Influenza, Td etc.)
  • Positive serum test results for hepatitis C virus, hepatitis B virus surface antigen(HBsAg) or HIV
  • Severe hepatopathy which is Class C according to Child-Pough's classification
  • Severe renal dysfunction where the creatinine clearance(CLcr) is lower than 30ml/min
  • CPK test results more than 2.5 times the upper limit of normal
  • Predisposed to inflammatory reaction due to use of medical devices such as electroporation within 30 days of screening visit
  • History of severe adverse drug events or severe allergic diseases
  • History of epilepsy or convulsion within 2 years prior to the screening visit
  • At the discretion of the investigator, the skin condition covering deltoid muscles, within 2cm of the intended sites of injection, is not suitable for injection due to infection, ulcer, edema, tattoo, scar, injury etc.
  • The thickness of skin fold covering deltoid muscles, intended injection sites, > 40mm
  • Any orthopedic artificial implant around the intended sites of electroporation (deltoid muscles)
  • Sinus bradycardia whose resting heart rate < 50 beats/min
  • Pre-excitation syndrome such as Wolff-Parkinson-White syndrome
  • Abnormal electrocardiography(ECG) including arrhythmia
  • Artificial implants or metallic implants
  • Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • Keimyung University Dongsan Medical Center

    Daegu, 700-712

  • Cheil General Hospital & Women's Healthcare Center

    Seoul, 100-380

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

    Seoul, 137-701

  • Korea University Guro Hospital

    Seoul, 152-703

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Multi-center, Phase 2 Clinical Trial to Determine the Optimal Dose and Evaluate the Safety of GX-188E, a DNA-based Therapeutic Vaccine, Administered Intramuscularly by Electroporation (EP) in HPV Type 16 and/or 18 Positive Patients With Cervical Intraepithelial Neoplasia 3 (CIN 3)

The purpose of this study is to determine the optimal dose of GX-188E for the Phase 3 and access the efficacy and safety of GX-188E according the protocol in patients with Cervical Intraepithelial Neoplasia 3 (CIN3).

Read the detailed description

Subjects who are eligible for this study are allocated to one of the two treatment groups of GX-188E. All Subject received GX-188E intramuscularly using the electroporator(EP) on alternating deltoid muscles which will be performed totally three times during the study period.

Being tested
GX-188E
Keywords
CIN3, Cervical Intraepithelial Neoplasia, High-Risk HPV, HPV Infection, Neoplasm, Precancerous Diseases, Uterine Diseases, Genital Diseases, Female
Medical subject headings
Uterine Cervical Dysplasia, Papillomavirus Infections, Neoplasms, Uterine Diseases, Genital Diseases, Female

What participants receive

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

  • GX-188EBiological

    Also called DNA therapeutic vaccine

    DNA vaccine administered via IM route using TDS-IM electroporation device

Study groups in NCT02139267
Study groupRoleWhat they receive
1mg of GX-188E per doseExperimental1mg of GX-188E per dose will be administered on 1mg group participants through intramuscular route using EP device. The injection points are at 0 week, 4 week and 12 week.
Receives: Biological: GX-188E
4mg of GX-188E per doseExperimental4mg of GX-188E per dose will be administered on 4mg group participants through intramuscular route using EP device. The injection points are at 0 week, 4 week and 12week.
Receives: Biological: GX-188E

What is being measured

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

  1. The Rate of Participants with Histopathological Regression of Cervical Lesions to CIN1 or Less

    Measured: 20 weeks

Secondary outcomes (8)

  1. The Rate of Participants Whose Result Inverted Negative in HPV DNA test

    Measured: 20 weeks

  2. The rate of HPV E6, E7-specific ELISPOT responder defined in the protocol

    Measured: 20 weeks

  3. Cytological Changes of the Cervical Lesions

    Measured: 20 weeks

  4. The Rate of Adverse Events and the Related Features after Administration of Investigational Product

    Measured: 20 weeks

  5. The Rate of Solicited Adverse Events and the Related Features

    Measured: 20 weeks

  6. Data in Physical examination, Vital signs, Electrocardiography, Clinical Laboratory Test Results Related to Investigational Product

    Measured: 20 weeks

  7. Mean Value of Visual Analogue Scale on Pain Intensity

    Measured: 20 weeks

  8. Flt-3L Serum Concentration

    Measured: 20 weeks

Timeline

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

  1. First posted15 May 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionMar 2016
  4. Study completionMar 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02139267
Sponsor's protocol ID
GX-188E_CIN3_P2
Status last verified
Jul 2017
First submitted
13 May 2014
Last updated
12 Jul 2017
Results posted
No
Data monitoring committee
No

Publications

  • Cho HW, Jeong S, Song SH, Kim YT, Kim JW, Cho CH, Hur SY, Chang SJ, Kim YM, Lee JK. A phase 1/2a, dose-escalation, safety, and preliminary efficacy study of the RKP00156 vaginal tablet in healthy women and patients with cervical intraepithelial neoplasia 2. J Gynecol Oncol. 2024 Jul;35(4):e52. doi: 10.3802/jgo.2024.35.e52. Epub 2024 Jan 24.

    PubMed 38330377

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GX-188E in people with Cervical Intraepithelial Neoplasia, run by Genexine, Inc. at 4 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 7 inclusion and 23 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 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 phase mean?

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?

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?

The Rate of Participants with Histopathological Regression of Cervical Lesions to CIN1 or Less (time frame: 20 weeks). 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 NCT02139267, 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 12 Jul 2017.

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