Anal Cancer, Anus Neoplasms, HIV Infection, HSIL, High-Grade Squamous Intraepithelial Lesions, Human Papilloma Virus Infection
Conditions
Brief summary
This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection.
Interventions
DRUGABI-1968
Topical cream applied at Day 1 for the SAD portion and applied at Day 1, Day 8, Day 15, Day 22 and Day 29 for the MAD portion
Sponsors
Antiva Biosciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study will be conducted in 2 Phases: Part A, up to 5 cohorts of 3 subjects each will receive a single dose of ABI-1968 Topical Cream. In Part B, three cohorts (3 subjects per cohort) will receive multiple doses in 3 ascending dose strengths of ABI-1968 Topical Cream. After completing the ascending dose multiple-dosing cohorts, a multiple-dosing Cohort Expansion group of 30 subjects will be initiated.
Eligibility
Sex/Gender
ALL
Age
27 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female or male subjects, at least 27 years old. 2. Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining) 3. Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer. 4. For HIV-positive subjects, CD4 count must be at least 200/mm3 with undetectable (\<50 copies/mL) viral load within the 3 months prior to enrollment. Subjects must be on a stable regimen of antiretroviral drugs for the 3 months prior to enrollment.
Exclusion criteria
1. Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females. 2. Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment. 3. History of cancer, including anal cancer (with the exception of basal cell or squamous cell carcinoma of the skin), or currently undergoing treatment for any skin cancer. 4. History of genital herpes with \> 3 outbreaks per year. 5. Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL | SAD portion is 29 days/MAD portion is 84 days | Number of participants with Adverse Events related to treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal. | SAD portion is 29 days/MAD portion is 84 days | Plasma concentrations of ABI-1968 over time |
| Histopathology of areas with biopsy-proven disease following single and multiple doses of ABI-1968 Topical Cream. | SAD portion is 29 days/MAD portion is 84 days | Number of subjects with complete and or partial regression of aHSIL by High Resolution Anoscopy (HRA) and histopathology |
Countries
Australia, United States
Outcome results
None listed