Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions 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 cervical precancerous lesions in females without human immunodeficiency virus (HIV) infection.

Official Title
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An Open-Label Multiple-Dose, Dose Escalation Study To Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Participants With Cervical High Grade Squamous Intraepithelial Lesions

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

Intervention / Treatment
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* Drug: Topical ABI-1968


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women, 25 to 50 years old. Biopsy-confirmed cervical HSIL that is p16+ within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen. Colposcopy is satisfactory based on visualization of the entire squamo-columnar junction (SCJ). The borders of all lesions must be completely visible. The upper limit of the visible (usually aceto-white) lesion is within 3 quadrants or less at screening. Exclusion Criteria: Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females. HIV positive (tested at screening visit or within 3 months of screening visit). Resolution of visible CIN lesion prior to enrollment. ECC positive for glandular disease (adenocarcinoma in situ) or invasive cancer. History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

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<br>Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22 | Drug: Topical ABI-1968<br>* Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts<br>|
| Experimental: Dose 2<br>Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22 | Drug: Topical ABI-1968<br>* Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts<br>|
| Experimental: Dose 3<br>New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22 | Drug: Topical ABI-1968<br>* Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts<br>|
| Experimental: Dose 4<br>New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22 | Drug: Topical ABI-1968<br>* Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts<br>|
| Experimental: Dose 5<br>New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22 | Drug: Topical ABI-1968<br>* Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety & Tolerability of ABI-1968 for the treatment of cHSIL | Number of Adverse Events related to treatment | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic exposure to ABI-1968 Topical Cream following topical application to the cervix. | Plasma concentrations of ABI-1968 over time | 42 days |