HSIL of CervixPhase 1NCT03697226
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection.
A Phase 1 study testing Topical ABI-1968 in people with HSIL of Cervix and HSIL, High Grade Squamous Intraepithelial Lesions, run by Antiva Biosciences at 1 site in South Africa.
Trial summary
This study evaluates the use of ABI-1968, a topical cream, in the treatment of cervical precancerous lesions in females without human immunodeficiency virus (HIV) infection. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- HSIL of Cervix, HSIL, High Grade Squamous Intraepithelial Lesions, High-Grade Cervical Intraepithelial Neoplasia
- What is being tested?
- Topical ABI-1968
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSouth Africa
- Study dates
- 21 Dec 2018to 12 Jun 2020
- 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 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women, 25 to 50 years old.
- Biopsy-confirmed cervical HSIL that is p16+ within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen.
- Colposcopy is satisfactory based on visualization of the entire squamo-columnar junction (SCJ). The borders of all lesions must be completely visible.
- The upper limit of the visible (usually aceto-white) lesion is within 3 quadrants or less at screening.
Who cannot join
- Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
- HIV positive (tested at screening visit or within 3 months of screening visit).
- Resolution of visible CIN lesion prior to enrollment.
- ECC positive for glandular disease (adenocarcinoma in situ) or invasive cancer.
- History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Multiple-Dose, Dose Escalation Study To Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Participants With Cervical High Grade Squamous Intraepithelial Lesions
This study evaluates the use of ABI-1968, a topical cream, in the treatment of cervical precancerous lesions in females without human immunodeficiency virus (HIV) infection.
- Conditions
- HSIL of Cervix, HSIL, High Grade Squamous Intraepithelial Lesions, High-Grade Cervical Intraepithelial Neoplasia, Human Papilloma Virus, HIV Negative, Cervical Cancer
- Being tested
- Topical ABI-1968
- Medical subject headings
- Squamous Intraepithelial Lesions, Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical ABI-1968Drug
Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22 Receives: Drug: Topical ABI-1968 |
| Dose 2 | Experimental | Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22 Receives: Drug: Topical ABI-1968 |
| Dose 3 | Experimental | New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22 Receives: Drug: Topical ABI-1968 |
| Dose 4 | Experimental | New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22 Receives: Drug: Topical ABI-1968 |
| Dose 5 | Experimental | New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22 Receives: Drug: Topical ABI-1968 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & Tolerability of ABI-1968 for the treatment of cHSIL
Number of Adverse Events related to treatment
Measured: 42 days
Secondary outcomes (1)
Systemic exposure to ABI-1968 Topical Cream following topical application to the cervix.
Plasma concentrations of ABI-1968 over time
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start21 Dec 2018
- Primary completion26 May 2020
- Study completion12 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HSIL of CervixStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antiva Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697226
- Sponsor's protocol ID
- ABI-1968-103
- Status last verified
- Jul 2019
- First submitted
- 25 Sep 2018
- Last updated
- 13 Jan 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Multiple-Dose, Dose Escalation Study To Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Participants With Cervical High Grade Squamous Intraepithelial Lesions
- ClinicalTrials.gov ID
- NCT03697226
- Acronym / sponsor ID
- ABI-1968-103
- Conditions
- HSIL of Cervix, HSIL, High Grade Squamous Intraepithelial Lesions, High-Grade Cervical Intraepithelial Neoplasia, Human Papilloma Virus, HIV Negative, Cervical Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Antiva BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 26 May 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 5 Oct 2018 (actual)
- 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 evaluates the use of ABI-1968, a topical cream, in the treatment of cervical precancerous lesions in females without human immunodeficiency virus (HIV) infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: Topical ABI-1968Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22 |
| Dose 2 | Experimental | Drug: Topical ABI-1968Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22 |
| Dose 3 | Experimental | Drug: Topical ABI-1968New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22 |
| Dose 4 | Experimental | Drug: Topical ABI-1968New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22 |
| Dose 5 | Experimental | Drug: Topical ABI-1968New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22 |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women, 25 to 50 years old.
- Biopsy-confirmed cervical HSIL that is p16+ within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen.
- Colposcopy is satisfactory based on visualization of the entire squamo-columnar junction (SCJ). The borders of all lesions must be completely visible.
- The upper limit of the visible (usually aceto-white) lesion is within 3 quadrants or less at screening.
Key exclusion criteria (5 listed)
- Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
- HIV positive (tested at screening visit or within 3 months of screening visit).
- Resolution of visible CIN lesion prior to enrollment.
- ECC positive for glandular disease (adenocarcinoma in situ) or invasive cancer.
- History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.
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 |
|---|---|---|
| Topical ABI-1968Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts | Drug | Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 |
Primary outcome
Safety & Tolerability of ABI-1968 for the treatment of cHSIL
Time frame: 42 days
Number of Adverse Events related to treatment
1 secondary outcome
Systemic exposure to ABI-1968 Topical Cream following topical application to the cervix.
Time frame: 42 days
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 13 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for HSIL of Cervix
Recruiting
Comparison Between Liquid-Based Cytology And Molecular Screening For Detecting Precursor Lesions and Cervical Cancer
I) Atypical Squamous Cells of Undetermined Significance (ASC-US), II) Atypical Glandular Cells of Uncertain Significance (AGUS)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Topical ABI-1968 in people with HSIL of Cervix and HSIL, High Grade Squamous Intraepithelial Lesions, run by Antiva Biosciences at 1 site in South Africa.
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 5 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 13 Jan 2021. 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 Africa. 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?
Safety & Tolerability of ABI-1968 for the treatment of cHSIL (time frame: 42 days). 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 13 Jan 2021; AzTrials last refreshed its copy on 26 Oct 2026.