Back to results

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

Primary Purpose

HSIL, High-Grade Squamous Intraepithelial Lesions, Human Papilloma Virus Infection, HIV Infection

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Topical ABI-1968 cream

About this trial

This is an interventional treatment trial for HSIL, High-Grade Squamous Intraepithelial Lesions

Eligibility Criteria

27 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

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.

Exclusion Criteria:

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.

Sites / Locations

Research Center
Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Dose 1 - Multiple Ascending Dose(MAD)

Dose 2 - Multiple Ascending Dose(MAD)

Dose 3 - Multiple Ascending Dose(MAD)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Number of participants with Adverse Events related to treatment

Secondary Outcome Measures

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

Plasma concentrations of ABI-1968 over time

Full Information

NCT ID

NCT03677960

First Posted

September 18, 2018

Last Updated

July 23, 2019

Sponsor

Antiva Biosciences

1. Study Identification

Unique Protocol Identification Number

NCT03677960

Brief Title

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

Official Title

Open-Label Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Multiple Doses Of Topical Abi-1968 In Subjects With Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Terminated

Why Stopped

Pre-Clinical Toxicology Findings

Study Start Date

December 17, 2018 (Actual)

Primary Completion Date

June 30, 2019 (Actual)

Study Completion Date

June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Antiva Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose 1 - Multiple Ascending Dose(MAD)

Arm Type

Experimental

Arm Description

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

Arm Title

Dose 2 - Multiple Ascending Dose(MAD)

Arm Type

Experimental

Arm Description

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

Arm Title

Dose 3 - Multiple Ascending Dose(MAD)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Topical ABI-1968 cream

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Number of participants with Adverse Events related to treatment

Time Frame

MAD portion is 84 days

Secondary Outcome Measure Information:

Title

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

Description

Plasma concentrations of ABI-1968 over time

Time Frame

MAD portion is 84 days

Other Pre-specified Outcome Measures:

Title

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

Description

Number of subjects with complete and or partial regression of aHSIL by High Resolution Anoscopy (HRA) and histopathology

Time Frame

MAD portion is 84 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

27 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria 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. Exclusion Criteria: 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.

Facility Information:

Facility Name

Research Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60614

Country

United States

Facility Name

Research Center

City

Darlinghurst

State/Province

Sydney

ZIP/Postal Code

2010

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs