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

Antiva Biosciences

Status and phase: Completed; Phase 1

Conditions: CIN - Cervical Intraepithelial Neoplasia; Human Papilloma Virus; High-Grade Cervical Intraepithelial Neoplasia; HSIL, High Grade Squamous Intraepithelial Lesions; Cervical Dysplasia; Cervical Neoplasm; Cervical Cancer; HIV Negative; HSIL of Cervix

Treatments: Drug: Topical ABI-1968

Study type: Interventional

Funder types: Industry

Identifiers

NCT03697226

ABI-1968-103

Details and patient eligibility

About

This study evaluates the use of ABI-1968, a topical cream, in the treatment of cervical precancerous lesions in females without human immunodeficiency virus (HIV) infection.

Enrollment: 8 patients

Sex: Female

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women, 25 to 50 years old.
2. Biopsy-confirmed cervical HSIL that is p16+ within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen.
3. Colposcopy is satisfactory based on visualization of the entire squamo-columnar junction (SCJ). The borders of all lesions must be completely visible.
4. The upper limit of the visible (usually aceto-white) lesion is within 3 quadrants or less at screening.

Exclusion criteria

1. Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
2. HIV positive (tested at screening visit or within 3 months of screening visit).
3. Resolution of visible CIN lesion prior to enrollment.
4. ECC positive for glandular disease (adenocarcinoma in situ) or invasive cancer.
5. History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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8 participants in 5 patient groups

Dose 1

Experimental group

Description:

Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22

Treatment:

Drug: Topical ABI-1968

Dose 2

Experimental group

Description:

Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22

Treatment:

Drug: Topical ABI-1968

Dose 3

Experimental group

Description:

New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22

Treatment:

Drug: Topical ABI-1968

Dose 4

Experimental group

Description:

New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22

Treatment:

Drug: Topical ABI-1968

Dose 5

Experimental group

Description:

New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22

Treatment:

Drug: Topical ABI-1968