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Cervical lesion drug trial halted early

NCT ID NCT05502367

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a vaginal insert called ABI-2280 in women with cervical precancerous lesions (CIN). The goal was to see if it was safe and could help clear the abnormal cells. The trial was stopped early, so we don't have full results. It involved 44 women aged 25-55 who used the insert themselves.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABI-2280 vaginal insert
What this could lead to
If it had worked, this could point toward a non-surgical treatment for cervical precancerous lesions.
What could go wrong
The trial was terminated early, so we don't have clear results. It was also a small, early-phase study, so success was never guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

44 people

The number who actually took part.

Started

Sep 2022

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 55 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Botho ke Bontle Health Services

    Waltloo, Gauteng, 0184, South Africa

  • CerviCusco

    Cusco, Peru

  • East Sydney Doctors

    Darlinghurst, New South Wales, 2010, Australia

  • Farmovs

    Bloemfontein, Free State, 9301, South Africa

  • Ginobs S.A.

    Lima, Peru

  • Gole Biomedical Research Centre

    Ga-Mothapo, Limpopo, South Africa

  • Nafasi Integrated Solutions

    Sunnyside, Gauteng, 0002, South Africa

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