Cervical Intraepithelial NeoplasiaPhase 1/2NCT05502367
A Study of ABI-2280 Vaginal Insert (Previously Referred to as ABI-2280 Vaginal Tablet) in Participants With Cervical Intraepithelial Neoplasia
A Phase 1/2 study testing ABI-2280 Vaginal Tablet/Insert in people with Cervical Intraepithelial Neoplasia, run by Antiva Biosciences at 7 sites in 3 countries.
Trial summary
This is an open-label study to evaluate the safety, tolerability, and efficacy of ABI-2280 in participants with cervical squamous intraepithelial lesions. This study is divided into 2 parts - Part A and Part B. Part A consists of up to 9 dose escalation cohorts. Part B consists of dose expansion cohorts. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- ABI-2280 Vaginal Tablet/Insert
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 10 Sep 2022to 27 Oct 2025
- Phase
- Phase 1/2
- 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 25 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women, 25 to 55 years old.
- For Cohorts A1 and A2 in Part A, participants with biopsy-confirmed CIN (with visible lesions) regardless of p16 positivity may be enrolled upon consultation with PI and Medical Monitor. These participants will not be required to get LLETZ if not medically necessary, as determined by the PI in consultation with the Medical Monitor.
- For Cohorts A3 and above in Part A and Part B POC cohorts, biopsy-confirmed cHSIL that is p16+ (p16INK4a expressed) within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen. If biopsy was performed ≥ 60 days before planned enrollment, participants must agree to have another biopsy performed at the Screening visit, unless approved by the Medical Monitor.
- A positive high-risk HPV (hrHPV) result by provider-obtained cervical swab at screening or previously obtained and documented within the past 3 months.
- No prior treatment for Cervical intraepithelial neoplasia (CIN).
- Generally, in good health with no clinically significant pulmonary, cardiac, gastro-enterologic, neurologic, renal, musculoskeletal, rheumatologic, metabolic, neoplastic, or endocrine disease.
Who cannot join
- Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
- Unwilling to use stringent methods of contraception (including barrier method, as well as another acceptable method) throughout the course of the study.
- History of cancer, except basal cell or squamous cell carcinoma of the skin.
- History of genital herpes with outbreak within prior 12 months.
- Have an active pelvic or non-HPV (Human papillomavirus) vaginal infection (e.g., that was detected by a positive urine screen for gonorrhea or chlamydial infection, bimanual exam consistent with pelvic inflammatory disease, positive bedside testing criteria for bacterial vaginosis, candida vaginitis or trichomonal vaginitis, etc).
- Current or recent abnormal vaginal discharge and /or abnormal vaginal bleeding.
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- Had a therapeutic abortion or miscarriage less than 3 months prior.
- Any clinically significant immune suppressing condition.
- Participants with a significant acute condition or any other condition that in the opinion of the Investigator might interfere with the evaluation of the study objectives.
- Women who, in the PI's judgment, would be harmed by the delay in undergoing definitive treatment as a result of study participation and the ABI-2280 Vaginal Tablet dosing schedule.
- Vaccination (even 1 dose) with a prophylactic HPV vaccine (i.e., Gardasil®, Gardasil®-9 or Cervarix®) in the last 3 months.
- Vaccination with a therapeutic HPV vaccine.
- Other inclusion/exclusion criteria may apply
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
South Africa4 sites
Farmovs
Bloemfontein, Free State, 9301
Gole Biomedical Research Centre
Ga-Mothapo, Limpopo
Nafasi Integrated Solutions
Sunnyside, Gauteng, 0002
Botho ke Bontle Health Services
Waltloo, Gauteng, 0184
About this study
Official title: An Open-Label Single and Multiple-dose, Study to Evaluate Safety, Tolerability and Efficacy of ABI-2280 Vaginal Insert (Previously Referred to as ABI-2280 Vaginal Tablet) in Participants With Cervical Squamous Intraepithelial Lesions
This is an open-label study to evaluate the safety, tolerability, and efficacy of ABI-2280 in participants with cervical squamous intraepithelial lesions. This study is divided into 2 parts - Part A and Part B.
Part A consists of up to 9 dose escalation cohorts. Part B consists of dose expansion cohorts.
Participants will self-administer ABI-2280.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- ABI-2280 Vaginal Tablet/Insert
- 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.
ABI-2280 Vaginal Tablet/InsertDrug
Vaginal Tablet
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1: Single and multiple doses of ABI-2280 | Experimental | Not described Receives: Drug: ABI-2280 Vaginal Tablet/Insert |
| Cohort A2: Multiple doses of ABI-2280 | Experimental | Not described Receives: Drug: ABI-2280 Vaginal Tablet/Insert |
| Cohort A3: Multiple doses of ABI-2280 | Experimental | Not described Receives: Drug: ABI-2280 Vaginal Tablet/Insert |
| Cohort A4: Multiple doses of ABI-2280 | Experimental | Not described Receives: Drug: ABI-2280 Vaginal Tablet/Insert |
| Cohort A5: Multiple doses of ABI-2280 | Experimental | Not described Receives: Drug: ABI-2280 Vaginal Tablet/Insert |
| Cohort A6: Multiple doses of ABI-2280 | Experimental | Not described Receives: Drug: ABI-2280 Vaginal Tablet/Insert |
| Cohort A7: Multiple doses of ABI-2280 | Experimental | Not described Receives: Drug: ABI-2280 Vaginal Tablet/Insert |
| Cohort A8: Intermittent multiple doses of ABI-2280 | Experimental | Not described Receives: Drug: ABI-2280 Vaginal Tablet/Insert |
| Cohort A9: Multiple doses of ABI-2280 | Experimental | Not described Receives: Drug: ABI-2280 Vaginal Tablet/Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (Safety and Tolerability)
For Parts A and B, to assess the safety and tolerability of ABI-2280 Vaginal Tablet by the incidence and severity of Adverse events (AEs).
Measured: From Baseline to Day 42 post dose administration
Secondary outcomes (2)
Histopathologic changes in cHSIL by large loop excision of the transformation zone (LLETZ) speciment
To assess histopathologic changes in cHSIL by LLETZ
Measured: 12 weeks after the first dose of ABI-2280 Vaginal Tablet
Pharmacokinetics of ABI-2280 after single and multiple doses
Pharmacokinetics sampling of ABI-2280 will be taken at various time points after single and multiple doses to assess systemic exposure.
Measured: PK time points will begin on Day 1 and will continue up to Day 49 (depending on the Cohort)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start10 Sep 2022
- Primary completion27 Oct 2025
- Study completion27 Oct 2025
Why it stopped: Study terminated early due to Antiva business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 44 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
- NCT05502367
- Sponsor's protocol ID
- ABI-2280-303
- Status last verified
- Feb 2026
- First submitted
- 7 Aug 2022
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Single and Multiple-dose, Study to Evaluate Safety, Tolerability and Efficacy of ABI-2280 Vaginal Insert (Previously Referred to as ABI-2280 Vaginal Tablet) in Participants With Cervical Squamous Intraepithelial Lesions
- ClinicalTrials.gov ID
- NCT05502367
- Acronym / sponsor ID
- ABI-2280-303
- Conditions
- Cervical Intraepithelial Neoplasia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated early due to Antiva business decision.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Antiva BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 16 Aug 2022 (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 is an open-label study to evaluate the safety, tolerability, and efficacy of ABI-2280 in participants with cervical squamous intraepithelial lesions. This study is divided into 2 parts - Part A and Part B.
Part A consists of up to 9 dose escalation cohorts. Part B consists of dose expansion cohorts.
Participants will self-administer ABI-2280.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort A1: Single and multiple doses of ABI-2280 | Experimental | Drug: ABI-2280 Vaginal Tablet/Insert |
| Cohort A2: Multiple doses of ABI-2280 | Experimental | Drug: ABI-2280 Vaginal Tablet/Insert |
| Cohort A3: Multiple doses of ABI-2280 | Experimental | Drug: ABI-2280 Vaginal Tablet/Insert |
| Cohort A4: Multiple doses of ABI-2280 | Experimental | Drug: ABI-2280 Vaginal Tablet/Insert |
| Cohort A5: Multiple doses of ABI-2280 | Experimental | Drug: ABI-2280 Vaginal Tablet/Insert |
| Cohort A6: Multiple doses of ABI-2280 | Experimental | Drug: ABI-2280 Vaginal Tablet/Insert |
| Cohort A7: Multiple doses of ABI-2280 | Experimental | Drug: ABI-2280 Vaginal Tablet/Insert |
| Cohort A8: Intermittent multiple doses of ABI-2280 | Experimental | Drug: ABI-2280 Vaginal Tablet/Insert |
| Cohort A9: Multiple doses of ABI-2280 | Experimental | Drug: ABI-2280 Vaginal Tablet/Insert |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women, 25 to 55 years old.
- For Cohorts A1 and A2 in Part A, participants with biopsy-confirmed CIN (with visible lesions) regardless of p16 positivity may be enrolled upon consultation with PI and Medical Monitor. These participants will not be required to get LLETZ if not medically necessary, as determined by the PI in consultation with the Medical Monitor.
- For Cohorts A3 and above in Part A and Part B POC cohorts, biopsy-confirmed cHSIL that is p16+ (p16INK4a expressed) within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen. If biopsy was performed ≥ 60 days before planned enrollment, participants must agree to have another biopsy performed at the Screening visit, unless approved by the Medical Monitor.
- A positive high-risk HPV (hrHPV) result by provider-obtained cervical swab at screening or previously obtained and documented within the past 3 months.
- No prior treatment for Cervical intraepithelial neoplasia (CIN).
Key exclusion criteria (13 listed)
- Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
- Unwilling to use stringent methods of contraception (including barrier method, as well as another acceptable method) throughout the course of the study.
- History of cancer, except basal cell or squamous cell carcinoma of the skin.
- History of genital herpes with outbreak within prior 12 months.
- Have an active pelvic or non-HPV (Human papillomavirus) vaginal infection (e.g., that was detected by a positive urine screen for gonorrhea or chlamydial infection, bimanual exam consistent with pelvic inflammatory disease, positive bedside testing criteria for bacterial vaginosis, candida vaginitis or trichomonal vaginitis, etc).
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 |
|---|---|---|
| ABI-2280 Vaginal Tablet/InsertVaginal Tablet | Drug | Cohort A1: Single and multiple doses of ABI-2280, Cohort A2: Multiple doses of ABI-2280, Cohort A3: Multiple doses of ABI-2280, Cohort A4: Multiple doses of ABI-2280, Cohort A5: Multiple doses of ABI-2280, Cohort A6: Multiple doses of ABI-2280, Cohort A7: Multiple doses of ABI-2280, Cohort A8: Intermittent multiple doses of ABI-2280, Cohort A9: Multiple doses of ABI-2280 |
Primary outcome
Incidence of Adverse Events (Safety and Tolerability)
Time frame: From Baseline to Day 42 post dose administration
For Parts A and B, to assess the safety and tolerability of ABI-2280 Vaginal Tablet by the incidence and severity of Adverse events (AEs).
2 secondary outcomes
Histopathologic changes in cHSIL by large loop excision of the transformation zone (LLETZ) speciment
Time frame: 12 weeks after the first dose of ABI-2280 Vaginal Tablet
Pharmacokinetics of ABI-2280 after single and multiple doses
Time frame: PK time points will begin on Day 1 and will continue up to Day 49 (depending on the Cohort)
Results and safety
The study was stopped early (reason given: Study terminated early due to Antiva business decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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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.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ABI-2280 Vaginal Tablet/Insert in people with Cervical Intraepithelial Neoplasia, run by Antiva Biosciences at 7 sites in 3 countries.
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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Africa, Peru, Australia. 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 combined 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.
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 was stopped early (reason given: Study terminated early due to Antiva business decision.). Results are not available in the source record.
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?
Incidence of Adverse Events (Safety and Tolerability) (time frame: From Baseline to Day 42 post dose administration). 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 19 Feb 2026.