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

NCT03677960 | Terminated Phase 1 FDA Drug

• 1 other identifier: ABI-1968-202
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 2

Brief Summary

This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection

Conditions

HSIL, High-Grade Squamous Intraepithelial Lesions; Human Papilloma Virus Infection; HIV Infection; Anal Cancer; Anus Neoplasm

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL

  Number of participants with Adverse Events related to treatment

  MAD portion is 84 days

Secondary Outcomes (1)

• Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.

  MAD portion is 84 days

Other Outcomes (1)

• Histopathology of areas with biopsy-proven disease following multiple doses of ABI-1968 Topical Cream.

  MAD portion is 84 days

Study Arms (3)

Dose 1 - Multiple Ascending Dose(MAD)

EXPERIMENTAL

Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic

Drug: Topical ABI-1968 cream

Dose 2 - Multiple Ascending Dose(MAD)

EXPERIMENTAL

Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic

Drug: Topical ABI-1968 cream

Dose 3 - Multiple Ascending Dose(MAD)

EXPERIMENTAL

Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic

Drug: Topical ABI-1968 cream

Interventions

Topical ABI-1968 cream DRUG

Multiple doses of Topical ABI-1968 Cream administered by the Investigator in the clinic up to Day 29

Dose 1 - Multiple Ascending Dose(MAD); Dose 2 - Multiple Ascending Dose(MAD); Dose 3 - Multiple Ascending Dose(MAD)

Eligibility Criteria

• Age: 27 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male subjects, at least 27 years old.
• Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining)
• Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer.
• For HIV-positive subjects, CD4 count must be at least 200/mm3 with undetectable (\<50 copies/mL) viral load within the 3 months prior to enrollment. Subjects must be on a stable regimen of antiretroviral drugs for the 3 months prior to enrollment.

You may not qualify if:

• Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females.
• Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment.
• History of cancer involving the anogenital region, or history of other cancers that have not been fully resolved and free of symptoms in the past 5 years
• History of genital herpes with \> 3 outbreaks per year.
• Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.

Sponsors & Collaborators

• Antiva Biosciences: lead

Study Sites (2)

Research Center

Chicago, Illinois, 60614, United States

Location

Research Center

Darlinghurst, Sydney, 2010, Australia

Location

MeSH Terms

Conditions

Squamous Intraepithelial Lesions; Papillomavirus Infections; HIV Infections; Anus Neoplasms

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Blood-Borne Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 19, 2018
• Study Start: December 17, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-04

Locations

US (1); AU (1)