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

Antiva Biosciences

Status and phase: Completed; Phase 1

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

Treatments: Drug: ABI-1968

Study type: Interventional

Funder types: Industry

Identifiers

NCT03202992

ABI-1968-201

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: 57 patients

Sex: All

Ages: 27+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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57 participants in 10 patient groups

Dose 1 -Single Ascending Dose (SAD)

Experimental group

Description:

SAD Dose Level 1 of ABI-1968 topical cream applied on Day 1 of the study

Treatment:

Drug: ABI-1968

Dose 2 -Single Ascending Dose (SAD)

Experimental group

Description:

SAD Dose Level 2 of ABI-1968 topical cream applied on Day 1 of the study

Treatment:

Drug: ABI-1968

Dose 3 -Single Ascending Dose(SAD)

Experimental group

Description:

SAD Dose Level 3 of ABI-1968 topical cream applied on Day 1 of the study

Treatment:

Drug: ABI-1968

Dose 4 -Single Ascending Dose(SAD)

Experimental group

Description:

SAD Dose Level 4 of ABI-1968 topical cream applied on Day 1 of the study

Treatment:

Drug: ABI-1968

Dose 5 -Single Ascending Dose(SAD)

Experimental group

Description:

SAD Dose Level 5 of ABI-1968 topical cream applied on Day 1 of the study

Treatment:

Drug: ABI-1968

Dose 1 - Multiple Ascending Dose(MAD)

Experimental group

Description:

MAD Dose Level 1 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29

Treatment:

Drug: ABI-1968

Dose 2 -Multiple Ascending Dose(MAD)

Experimental group

Description:

MAD Dose Level 2 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29

Treatment:

Drug: ABI-1968

Dose 3 -Multiple Ascending Dose(MAD)

Experimental group

Description:

MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29

Treatment:

Drug: ABI-1968

Multiple Ascending Dose (MAD) Cohort Expansion

Experimental group

Description:

MAD Cohort Expansion of ABI-1968 applied at Day 1, Day 8, Day 15, Day 22 and Day 29

Treatment:

Drug: ABI-1968

Dose 4-Multiple Ascending Dose(MAD)

Experimental group

Description:

MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29

Treatment:

Drug: ABI-1968