Cervical lesion drug trial halted early
NCT ID NCT05502367
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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44 people
The number who actually took part.
- Started
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Sep 2022
- Finished
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Oct 2025
- Lead sponsor
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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
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Female participants only
- Healthy volunteers
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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 Hide 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
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Botho ke Bontle Health Services
Waltloo, Gauteng, 0184, South Africa
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CerviCusco
Cusco, Peru
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East Sydney Doctors
Darlinghurst, New South Wales, 2010, Australia
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Farmovs
Bloemfontein, Free State, 9301, South Africa
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Ginobs S.A.
Lima, Peru
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Gole Biomedical Research Centre
Ga-Mothapo, Limpopo, South Africa
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Nafasi Integrated Solutions
Sunnyside, Gauteng, 0002, South Africa
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a portable heat device match cryotherapy for cervical precancer?
- Could a Light-Activated cream replace surgery for cervical precancer?
- Cervical surgery may alter blood flow to the uterus
- Enzyme-HPV link in cervical disease explored
- Anesthesia choice may change surgical outcomes in cervical treatment
- Ice pack on the belly may ease pain after keyhole hysterectomy