Cervical Intraepithelial Neoplasia 3Phase 1CIN3NCT01634503
Safety of GX-188E DNA Therapeutic Vaccine Administered by Electroporation to Cervical Intraepithelial Neoplasia Grade 3
A Phase 1 study testing GX-188E administered by electroporation in people with Cervical Intraepithelial Neoplasia 3, run by Genexine, Inc. at 1 site in South Korea.
Trial summary
This study is to determine maximum tolerable dose (MTD) of GX 188E by defining the safety profile the safety and maximum tolerated dose of GX-188E administered by electroporation in Cervical Intraepithelial Neoplasia grade 3 (CIN 3) patients. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia 3
- What is being tested?
- GX-188E administered by electroporation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Feb 2014
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female aged between 20 and 50(inclusive).
- Those who promised not to get pregnant from initiation to the first follow-up visit
- Who has diagnosed with Cervical Intraepithelial Neoplasia 3 by histopathologic examination and HPV type 16 or 18 detected
- Those who signed a voluntary written informed consent form for study participation.
Who cannot join
- Pregnant or lactating women.
- Administration of immunosuppressant or immunomodulator within 6 months prior to the enrollment
- Concomitant medication of any corticosteroid agents within 4 weeks prior to vaccination with the test drug
- Prior immunotherapy against HPV
- Administration of any blood products within 3 months prior to the screening visit
- Administration of any vaccine within 4 weeks prior to the screening visit (ex. Hepatitis A vaccine, Hepatitis B vaccine, Influenza vaccine, Td etc.)
Show all 19Show fewer
- Positive serum test results for hepatitis C virus, hepatitis B virus surface antigen(HBsAg), or HIV
- Prior participation in any clinical trial within 30 days prior to the screening visit
- Patients predisposed to inflammatory reaction due to use of medical devices such as electroporation within 30 days of screening visit
- Past 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)
- Any history of severe adverse drug events or severe allergic diseases
- Sinus bradycardia whose resting heart rate < 50beats/min.
- Pre-excitation syndrome such as Wolff-Parkinson-White syndrome
- Artificial implants or metallic implants
- Abnormal electrocardiography (ECG) including arrhythmia
- Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Cheil General Hospital & Women's Healthcare Center
Seoul
About this study
Official title: A Single Center, Open-label, Dose-escalating, Phase Ι Study to Evaluate the Safety of GX-188E Administered by Electroporation (EP) in DNA-based Therapeutic Vaccine for Patients With Cervical Intraepithelial Neoplasia Grade 3 (CIN 3)
This study is to determine maximum tolerable dose (MTD) of GX 188E by defining the safety profile the safety and maximum tolerated dose of GX-188E administered by electroporation in Cervical Intraepithelial Neoplasia grade 3 (CIN 3) patients.
Read the detailed description
This study is an open-label, dose-escalation, single-center, phase I study to evaluate the safety of GX-188E, a DNA-based therapeutic vaccine, administered by electroporation (EP) in patients with HPV-16 or HPV-18 associated cervical intraepithelial neoplasia grade 3 (CIN 3).
Each subject eligible to participate in the trial is given a subject number, which is assigned sequentially in ascending order, then allocated to only a single dose level of the drug. Three subjects are allocated at each dose level starting with 1mg whereby the dose is escalated in sequential subjects in ascending numerical order of subject ID.
Each subject visit the site three times for administration during the study and is given an intramuscular injection of GX-188E at a dose of 1mg, 2mg or 4mg by electroporation at each visit
The subjects conduct the follow-up visits twice, which are 8 weeks and 24 weeks after the third injection of GX-188E respectively.
- Conditions
- Cervical Intraepithelial Neoplasia 3
- Being tested
- GX-188E administered by electroporation
- Keywords
- 3+3 design, Phase 1, Cervical Intraepithelial Neoplasia, Adult, Safety, Dose Finding
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GX-188E administered by electroporationGenetic
Also called Trigrid™ Delivery System
Patients will be assigned to three dose groups:1mg, 2mg, and 4mg. Each patient will be administered GX-188E by electroporation in entire study period. The Maximum Tolerated Dose of GX-188E will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.
| Study group | Role | What they receive |
|---|---|---|
| 1mg of GX-188E by electroporation | Experimental | Not described Receives: Genetic: GX-188E administered by electroporation |
| 2mg of GX-188E by electroporation | Experimental | Not described Receives: Genetic: GX-188E administered by electroporation |
| 4mg of GX-188E by electroporation | Experimental | Not described Receives: Genetic: GX-188E administered by electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of maximum MTD by defining the safety profile of GX-188E
It would be determined based on the rate and severity grade of events or abnormalities through evaluating systemic or local adverse events, clinical laboratory test results, vital signs and so on.
Measured: From baseline to end of study
Secondary outcomes (3)
The expression levels of GX-188E in blood
Measured: At week -2, week 2, week 12 ,week 20 and week 36
Immunologic reactogenicity by measuring HPV E6 and E7 specific T cell response (IFN-γ ELISPOT)
Measured: At week -2, week 2, week 12 ,week 20 and week 36
The changes of the involved lesions and HPV infection status
Measured: Baseline, week 12 ,week 20 and week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial Neoplasia 3Studies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genexine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tae Jin Kim, Principal investigator, Cheil General Hospital & Women's Healthcare Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634503
- Sponsor's protocol ID
- GX-188E-SN
- Acronym
- CIN3
- Status last verified
- Feb 2014
- First submitted
- 3 Jul 2012
- Last updated
- 17 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-label, Dose-escalating, Phase Ι Study to Evaluate the Safety of GX-188E Administered by Electroporation (EP) in DNA-based Therapeutic Vaccine for Patients With Cervical Intraepithelial Neoplasia Grade 3 (CIN 3)
- ClinicalTrials.gov ID
- NCT01634503
- Acronym / sponsor ID
- CIN3 / GX-188E-SN
- Conditions
- Cervical Intraepithelial Neoplasia 3
- Keywords
- 3+3 design, Phase 1, Cervical Intraepithelial Neoplasia, Adult, Safety, Dose Finding
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Genexine, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 6 Jul 2012 (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.
This study is to determine maximum tolerable dose (MTD) of GX 188E by defining the safety profile the safety and maximum tolerated dose of GX-188E administered by electroporation in Cervical Intraepithelial Neoplasia grade 3 (CIN 3) patients.
Detailed description
This study is an open-label, dose-escalation, single-center, phase I study to evaluate the safety of GX-188E, a DNA-based therapeutic vaccine, administered by electroporation (EP) in patients with HPV-16 or HPV-18 associated cervical intraepithelial neoplasia grade 3 (CIN 3).
Each subject eligible to participate in the trial is given a subject number, which is assigned sequentially in ascending order, then allocated to only a single dose level of the drug. Three subjects are allocated at each dose level starting with 1mg whereby the dose is escalated in sequential subjects in ascending numerical order of subject ID.
Each subject visit the site three times for administration during the study and is given an intramuscular injection of GX-188E at a dose of 1mg, 2mg or 4mg by electroporation at each visit
The subjects conduct the follow-up visits twice, which are 8 weeks and 24 weeks after the third injection of GX-188E respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1mg of GX-188E by electroporation | Experimental | Genetic: GX-188E administered by electroporation |
| 2mg of GX-188E by electroporation | Experimental | Genetic: GX-188E administered by electroporation |
| 4mg of GX-188E by electroporation | Experimental | Genetic: GX-188E administered by electroporation |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female aged between 20 and 50(inclusive).
- Those who promised not to get pregnant from initiation to the first follow-up visit
- Who has diagnosed with Cervical Intraepithelial Neoplasia 3 by histopathologic examination and HPV type 16 or 18 detected
- Those who signed a voluntary written informed consent form for study participation.
Key exclusion criteria (19 listed)
- Pregnant or lactating women.
- Administration of immunosuppressant or immunomodulator within 6 months prior to the enrollment
- Concomitant medication of any corticosteroid agents within 4 weeks prior to vaccination with the test drug
- Prior immunotherapy against HPV
- Administration of any blood products within 3 months prior to the screening visit
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 |
|---|---|---|
| GX-188E administered by electroporationAlso: Trigrid™ Delivery SystemPatients will be assigned to three dose groups:1mg, 2mg, and 4mg. Each patient will be administered GX-188E by electroporation in entire study period. The Maximum Tolerated Dose of GX-188E will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18. | Genetic | 1mg of GX-188E by electroporation, 2mg of GX-188E by electroporation, 4mg of GX-188E by electroporation |
Primary outcome
Determination of maximum MTD by defining the safety profile of GX-188E
Time frame: From baseline to end of study
It would be determined based on the rate and severity grade of events or abnormalities through evaluating systemic or local adverse events, clinical laboratory test results, vital signs and so on.
3 secondary outcomes
The expression levels of GX-188E in blood
Time frame: At week -2, week 2, week 12 ,week 20 and week 36
Immunologic reactogenicity by measuring HPV E6 and E7 specific T cell response (IFN-γ ELISPOT)
Time frame: At week -2, week 2, week 12 ,week 20 and week 36
The changes of the involved lesions and HPV infection status
Time frame: Baseline, week 12 ,week 20 and week 36
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 17 Feb 2014.
Related trials for Cervical Intraepithelial Neoplasia 3
Not yet recruitingPhase 2
Exploratory Study of the Efficacy of HAL-PDT in CIN 3
Cervical Intraepithelial Neoplasia Grade 3
Enrolling by invitation
Local Hyperthermia for the Treatment of Cervical Persistent High-risk Infection
Cervical Intraepithelial Neoplasia (CIN), Human Papillovirus
Not yet recruitingPhase 2
Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya
HIV Infections, HPV Infection
Not yet recruitingObservational study
Peripheral Blood CyTOF Immune Model for Cervical Lesion Detection in HPV16/18+ Women
CIN 2/3, Cervical Cancer (Early Detection)
RecruitingPhase 2
PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia
Cervical Intraepithelial Neoplasia Grade 2/3, Human Papilloma Virus Infection Type 16
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.
Tae Jin Kim principal investigator
Cheil General Hospital & Women's Healthcare Center
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 GX-188E administered by electroporation in people with Cervical Intraepithelial Neoplasia 3, 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 4 inclusion and 19 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 17 Feb 2014. 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?
Determination of maximum MTD by defining the safety profile of GX-188E (time frame: From baseline to end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2014.