Evaluating ABI-2280 Vaginal Insert for Cervical Intraepithelial Neoplasia

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 study is testing a new vaginal insert called ABI-2280 to see if it can safely and effectively help women with cervical intraepithelial neoplasia (CIN).

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 25 Years to 55 Years
• Sex: Female
• Sponsor: Antiva Biosciences (Industry-sponsored)
• Locations: 7 sites (Darlinghurst, New South Wales and 6 other locations)
• Trial ID: NCT05502367 on ClinicalTrials.gov

What this trial studies

This open-label study assesses the safety, tolerability, and efficacy of ABI-2280, a vaginal insert, in women diagnosed with cervical intraepithelial neoplasia (CIN). The study is divided into two parts: Part A involves dose escalation cohorts, while Part B focuses on dose expansion cohorts. Participants will self-administer the treatment, allowing for real-world application of the intervention. The study aims to gather data on the effectiveness of ABI-2280 in managing CIN.

Who should consider this trial

Good fit: Ideal candidates are women aged 25 to 55 with biopsy-confirmed CIN and a positive high-risk HPV result.

Not a fit: Patients with prior treatment for cervical intraepithelial neoplasia or those with invasive cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-invasive option for managing cervical intraepithelial neoplasia, potentially reducing the need for surgical interventions.

How similar studies have performed: While this approach is novel, similar studies targeting CIN have shown promise in the past, indicating potential for success.

Eligibility criteria

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

Where this trial is running

Darlinghurst, New South Wales and 6 other locations

• East Sydney Doctors — Darlinghurst, New South Wales, Australia (Recruiting)
• CerviCusco — Cusco, Peru (Recruiting)
• Ginobs S.A. — Lima, Peru (Recruiting)
• Farmovs — Bloemfontein, Free State, South Africa (Recruiting)
• Nafasi Integrated Solutions — Sunnyside, Gauteng, South Africa (Recruiting)
• Botho ke Bontle Health Services — Waltloo, Gauteng, South Africa (Recruiting)
• Gole Biomedical Research Centre — Ga-Mothapo, Limpopo, South Africa (Recruiting)

Study contacts

• Study coordinator: Annie Warsi, MD

Conditions Cervical Intraepithelial Neoplasia