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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03697226
• Other study ID #: ABI-1968-103
• Status: Completed
• Phase: Phase 1
• Start date: December 21, 2018
• Est. completion date: June 12, 2020

Study information

• Verified date: July 2019
• Source: Antiva Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 12, 2020
• Est. primary completion date: May 26, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Cancer
• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• Cervical Neoplasm
• CIN - Cervical Intraepithelial Neoplasia
• High-Grade Cervical Intraepithelial Neoplasia
• HIV Negative
• HSIL of Cervix
• HSIL, High Grade Squamous Intraepithelial Lesions
• Human Papilloma Virus
• Neoplasms
• Papilloma
• Squamous Intraepithelial Lesions of the Cervix
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Drug:
• Topical ABI-1968
Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts

Locations

Country	Name	City	State
South Africa	Research Center	Bloemfontein	Free State Province

Sponsors (1)

Lead Sponsor	Collaborator
Antiva Biosciences

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Histopathology of areas with biopsy-proven disease	Number of subjects with complete and or partial regression of cHSIL by Histopathology	42 days
Other	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
Primary	Safety & Tolerability of ABI-1968 for the treatment of cHSIL	Number of Adverse Events related to treatment	42 days
Secondary	Systemic exposure to ABI-1968 Topical Cream following topical application to the cervix.	Plasma concentrations of ABI-1968 over time	42 days