A Study of ABI-2280 Vaginal Tablet in Participants With Cervical Intraepithelial Neoplasia
- Conditions
- Cervical Intraepithelial Neoplasia
- Interventions
- Drug: ABI-2280 Vaginal Tablet/Insert
- Registration Number
- NCT05502367
- Lead Sponsor
- Antiva Biosciences
- Brief 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 3 dose escalating cohorts. Part B is a dose expansion cohort.
Participants will self-administer ABI-2280.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 29
- Women, 25 to 55 years old.
- For 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 large loop excision of the transformation zone (LLETZ) if not medically necessary, as determined by the PI in consultation with the Medical Monitor.
- For Part B, biopsy-confirmed cervical HSIL that is p16+ (p16INK4a expressed) within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen. If biopsy was performed more than 60 days before planned enrollment, participants must agree to have another biopsy performed at the Screening visit, unless approved by the Medical Monitor.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A1: Single and multiple doses of ABI-2280 ABI-2280 Vaginal Tablet/Insert - Cohort A2: Multiple doses of ABI-2280 ABI-2280 Vaginal Tablet/Insert - Cohort A3: Multiple doses of ABI-2280 ABI-2280 Vaginal Tablet/Insert - Cohort A4: Multiple doses of ABI-2280 ABI-2280 Vaginal Tablet/Insert - Cohort A5: Multiple doses of ABI-2280 ABI-2280 Vaginal Tablet/Insert - Cohort A6: Multiple doses of ABI-2280 ABI-2280 Vaginal Tablet/Insert - Cohort A7: Multiple doses of ABI-2280 ABI-2280 Vaginal Tablet/Insert - Cohort A8: Intermittent multiple doses of ABI-2280 ABI-2280 Vaginal Tablet/Insert - Cohort A9: Multiple doses of ABI-2280 ABI-2280 Vaginal Tablet/Insert -
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (Safety and Tolerability) 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).
- Secondary Outcome Measures
Name Time Method Histopathologic changes in cHSIL by large loop excision of the transformation zone (LLETZ) speciment 12 weeks after the first dose of ABI-2280 Vaginal Tablet To assess histopathologic changes in cHSIL by LLETZ
Pharmacokinetics of ABI-2280 after single and multiple doses PK time points will begin on Day 1 and will continue up to Day 49 (depending on the Cohort) Pharmacokinetics sampling of ABI-2280 will be taken at various time points after single and multiple doses to assess systemic exposure.
Trial Locations
- Locations (7)
CerviCusco
🇵🇪Cusco, Peru
Ginobs S.A.
🇵🇪Lima, Peru
Farmovs
🇿🇦Bloemfontein, Free State, South Africa
Nafasi Integrated Solutions
🇿🇦Sunnyside, Gauteng, South Africa
Botho ke Bontle Health Services
🇿🇦Waltloo, Gauteng, South Africa
East Sydney Doctors
🇦🇺Darlinghurst, New South Wales, Australia
Gole Biomedical Research Centre
🇿🇦Ga-Mothapo, Limpopo, South Africa