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Completed

NCT Number: NCT03697226

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

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.

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Key information

Conditions

HSIL of Cervix CIN - Cervical Intraepithelial Neoplasia Cervical Cancer Cervical Dysplasia Cervical Neoplasm Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HIV Negative HSIL, High Grade Squamous Intraepithelial Lesions High-grade Cervical Intraepithelial Neoplasia Human Papilloma Virus Morphological and Microscopic Findings Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Precancerous Conditions Squamous Intraepithelial Lesions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Research Center

Bloemfontein, Free State, 9301, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical ABI-1968

Drug

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

Primary outcomes

  1. Safety & Tolerability of ABI-1968 for the treatment of cHSIL

    Time frame: 42 days

    Number of Adverse Events related to treatment

Secondary outcomes

  1. Systemic exposure to ABI-1968 Topical Cream following topical application to the cervix.

    Time frame: 42 days

    Plasma concentrations of ABI-1968 over time

Other outcomes

  1. Histopathology of areas with biopsy-proven disease

    Time frame: 42 days

    Number of subjects with complete and or partial regression of cHSIL by Histopathology

  2. Changes in HPV viral load following multiple doses of ABI-1968 Topical Cream

    Time frame: 42 days

    Changes from baseline in HPV viral load following multiple doses of ABI-1968 Topical Cream

Sponsors and collaborators

Lead sponsor

Antiva Biosciences

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2018
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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