Clinical trial NCT03202992: Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
Official title: Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Topical ABI-1968 in Subjects With Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HSIL, High-Grade Squamous Intraepithelial Lesions
Human Papilloma Virus Infection
HIV Infection
Anal Cancer
Anus Neoplasms
Lead sponsor: Antiva Biosciences
Sponsor class: INDUSTRY
First posted: 2017-06-29
Enrollment: 57
Sex: ALL
Minimum age (years): 27
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL
timeFrame: SAD portion is 29 days/MAD portion is 84 days
Secondary outcomes:
measure: Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.
timeFrame: SAD portion is 29 days/MAD portion is 84 days
measure: Histopathology of areas with biopsy-proven disease following single and multiple doses of ABI-1968 Topical Cream.
timeFrame: SAD portion is 29 days/MAD portion is 84 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Research Center
state: California
city: Orlando
country: United States
facility: Research Center
state: Florida
city: Chicago
country: United States
facility: Research Center
state: Illinois
city: New York
country: United States
facility: Research Center
state: New York
city: Winston-Salem
country: United States
facility: Research Center
state: North Carolina
city: Sydney
country: Australia
facility: Research Center
state: Darlinghurst
Study officials:
affiliation: Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may use the contacts provided below.
name: Clinical Operations
role: STUDY_CHAIR
References: