Cervical Intraepithelial Neoplasia
Conditions
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 up to 9 dose escalation cohorts. Part B consists of dose expansion cohorts. Participants will self-administer ABI-2280.
Interventions
DRUGABI-2280 Vaginal Tablet/Insert
Vaginal Tablet
Sponsors
Antiva Biosciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 55 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia, Peru, South Africa
Outcome results
None listed