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

Antiva Biosciences

Status and phase: Terminated; Phase 1

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

Treatments: Drug: Topical ABI-1968 cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT03677960

ABI-1968-202

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 27+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 involving the anogenital region, or history of other cancers that have not been fully resolved and free of symptoms in the past 5 years
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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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6 participants in 3 patient groups

Dose 1 - Multiple Ascending Dose(MAD)

Experimental group

Description:

Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic

Treatment:

Drug: Topical ABI-1968 cream

Dose 2 - Multiple Ascending Dose(MAD)

Experimental group

Description:

Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic

Treatment:

Drug: Topical ABI-1968 cream

Dose 3 - Multiple Ascending Dose(MAD)

Experimental group

Description:

Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic

Treatment:

Drug: Topical ABI-1968 cream