Brief Title
A Study of ABI-2280 Vaginal Tablet in Participants With Cervical Intraepithelial Neoplasia
Official Title
An Open-Label Single and Multiple-dose, Study to Evaluate Safety, Tolerability and Efficacy of ABI-2280 Vaginal Tablet in Participants With Cervical Squamous Intraepithelial Lesions
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Incidence of Adverse Events (Safety and Tolerability)
Secondary Outcome
Pharmacokinetics of ABI-2280 after single and multiple doses
Condition
Cervical Intraepithelial Neoplasia
Intervention
ABI-2280
Study Arms / Comparison Groups
ABI-2280 0.1mg
Description: 0.1mg vaginal tablet
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
29
Start Date
September 10, 2022
Completion Date
August 31, 2023
Primary Completion Date
July 1, 2023
Eligibility Criteria
Inclusion Criteria:
- 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.
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.
Gender
Female
Ages
25 Years - 55 Years
Accepts Healthy Volunteers
No
Contacts
, 650-822-1400, [email protected]
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT05502367
Organization ID
ABI-2280-303
Responsible Party
Sponsor
Study Sponsor
Antiva Biosciences
Study Sponsor
, ,
Verification Date
February 2023