Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection

Study Overview
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Brief Summary
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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

Official Title
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Open-Label Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Multiple Doses Of Topical Abi-1968 In Subjects With Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)

Conditions
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HSIL, High-Grade Squamous Intraepithelial Lesions, Human Papilloma Virus Infection, HIV Infection, Anal Cancer, Anus Neoplasm

Intervention / Treatment
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* Drug: Topical ABI-1968 cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Female or male subjects, at least 27 years old. Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining) Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer. 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: Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females. Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment. History of cancer involving the anogenital region, or history of other cancers that have not been fully resolved and free of symptoms in the past 5 years History of genital herpes with > 3 outbreaks per year. Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.

Ages Eligible for Study
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Minimum Age: 27 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1 - Multiple Ascending Dose(MAD)<br>Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic | Drug: Topical ABI-1968 cream<br>* Multiple doses of Topical ABI-1968 Cream administered by the Investigator in the clinic up to Day 29<br>|
| Experimental: Dose 2 - Multiple Ascending Dose(MAD)<br>Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic | Drug: Topical ABI-1968 cream<br>* Multiple doses of Topical ABI-1968 Cream administered by the Investigator in the clinic up to Day 29<br>|
| Experimental: Dose 3 - Multiple Ascending Dose(MAD)<br>Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic | Drug: Topical ABI-1968 cream<br>* Multiple doses of Topical ABI-1968 Cream administered by the Investigator in the clinic up to Day 29<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL | Number of participants with Adverse Events related to treatment | MAD portion is 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal. | Plasma concentrations of ABI-1968 over time | MAD portion is 84 days |