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

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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Human Papilloma Virus; HSIL, High Grade Squamous Intraepithelial Lesions; Cervical Dysplasia; HSIL of Cervix; High-Grade Cervical Intraepithelial Neoplasia; HIV Negative; CIN - Cervical Intraepithelial Neoplasia; Cervical Neoplasm
• Intervention / Treatment: Drug: Topical ABI-1968

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Africa
  • Free State Province
    • Bloemfontein, Free State Province, South Africa, 9301
      • Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose 1; Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22	Drug: Topical ABI-1968; Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts
Experimental: Dose 2; Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22	Drug: Topical ABI-1968; Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts
Experimental: Dose 3; New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22	Drug: Topical ABI-1968; Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts
Experimental: Dose 4; New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22	Drug: Topical ABI-1968; Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts
Experimental: Dose 5; New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22	Drug: Topical ABI-1968; Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histopathology of areas with biopsy-proven disease	Number of subjects with complete and or partial regression of cHSIL by Histopathology	42 days
Changes in HPV viral load following multiple doses of ABI-1968 Topical Cream	Changes from baseline in HPV viral load following multiple doses of ABI-1968 Topical Cream	42 days

Collaborators and Investigators

• Sponsor: Antiva Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2018
• Primary Completion (Actual): May 26, 2020
• Study Completion (Actual): June 12, 2020

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Precancerous Conditions; Neoplasms, Squamous Cell; Neoplasms; Uterine Cervical Neoplasms; Carcinoma in Situ; Cervical Intraepithelial Neoplasia; Carcinoma, Squamous Cell; Uterine Cervical Dysplasia; Papilloma; Squamous Intraepithelial Lesions of the Cervix
• Other Study ID Numbers: ABI-1968-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No