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

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ClinicalTrials.gov Identifier: NCT03202992
Recruitment Status : Active, not recruiting
First Posted : June 29, 2017
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Antiva Biosciences

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.

Condition or disease Intervention/treatment Phase
HSIL, High-Grade Squamous Intraepithelial Lesions Human Papilloma Virus Infection HIV Infection Anal Cancer Anus Neoplasms Drug: ABI-1968 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The study will be conducted in 2 Phases: Part A, up to 5 cohorts of 3 subjects each will receive a single dose of ABI-1968 Topical Cream. In Part B, three cohorts (3 subjects per cohort) will receive multiple doses in 3 ascending dose strengths of ABI-1968 Topical Cream. After completing the ascending dose multiple-dosing cohorts, a multiple-dosing Cohort Expansion group of 30 subjects will be initiated.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Topical ABI-1968 in Subjects With Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)
Actual Study Start Date : August 11, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose 1 -Single Ascending Dose (SAD)
SAD Dose Level 1 of ABI-1968 topical cream applied on Day 1 of the study
Drug: ABI-1968
Topical cream applied at Day 1 for the SAD portion and applied at Day 1, Day 8, Day 15, Day 22 and Day 29 for the MAD portion

Experimental: Dose 2 -Single Ascending Dose (SAD)
SAD Dose Level 2 of ABI-1968 topical cream applied on Day 1 of the study
Drug: ABI-1968
Topical cream applied at Day 1 for the SAD portion and applied at Day 1, Day 8, Day 15, Day 22 and Day 29 for the MAD portion

Experimental: Dose 3 -Single Ascending Dose(SAD)
SAD Dose Level 3 of ABI-1968 topical cream applied on Day 1 of the study
Drug: ABI-1968
Topical cream applied at Day 1 for the SAD portion and applied at Day 1, Day 8, Day 15, Day 22 and Day 29 for the MAD portion

Experimental: Dose 4 -Single Ascending Dose(SAD)
SAD Dose Level 4 of ABI-1968 topical cream applied on Day 1 of the study
Drug: ABI-1968
Topical cream applied at Day 1 for the SAD portion and applied at Day 1, Day 8, Day 15, Day 22 and Day 29 for the MAD portion

Experimental: Dose 5 -Single Ascending Dose(SAD)
SAD Dose Level 5 of ABI-1968 topical cream applied on Day 1 of the study
Drug: ABI-1968
Topical cream applied at Day 1 for the SAD portion and applied at Day 1, Day 8, Day 15, Day 22 and Day 29 for the MAD portion

Experimental: Dose 1 - Multiple Ascending Dose(MAD)
MAD Dose Level 1 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
Drug: ABI-1968
Topical cream applied at Day 1 for the SAD portion and applied at Day 1, Day 8, Day 15, Day 22 and Day 29 for the MAD portion

Experimental: Dose 2 -Multiple Ascending Dose(MAD)
MAD Dose Level 2 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
Drug: ABI-1968
Topical cream applied at Day 1 for the SAD portion and applied at Day 1, Day 8, Day 15, Day 22 and Day 29 for the MAD portion

Experimental: Dose 3 -Multiple Ascending Dose(MAD)
MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
Drug: ABI-1968
Topical cream applied at Day 1 for the SAD portion and applied at Day 1, Day 8, Day 15, Day 22 and Day 29 for the MAD portion

Experimental: Multiple Ascending Dose (MAD) Cohort Expansion
MAD Cohort Expansion of ABI-1968 applied at Day 1, Day 8, Day 15, Day 22 and Day 29
Drug: ABI-1968
Topical cream applied at Day 1 for the SAD portion and applied at Day 1, Day 8, Day 15, Day 22 and Day 29 for the MAD portion

Experimental: Dose 4-Multiple Ascending Dose(MAD)
MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29
Drug: ABI-1968
Topical cream applied at Day 1 for the SAD portion and applied at Day 1, Day 8, Day 15, Day 22 and Day 29 for the MAD portion




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL [ Time Frame: SAD portion is 29 days/MAD portion is 84 days ]
    Number of participants with Adverse Events related to treatment


Secondary Outcome Measures :
  1. Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal. [ Time Frame: SAD portion is 29 days/MAD portion is 84 days ]
    Plasma concentrations of ABI-1968 over time

  2. Histopathology of areas with biopsy-proven disease following single and multiple doses of ABI-1968 Topical Cream. [ Time Frame: SAD portion is 29 days/MAD portion is 84 days ]
    Number of subjects with complete and or partial regression of aHSIL by High Resolution Anoscopy (HRA) and histopathology



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   27 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female or male subjects, at least 27 years old.
  2. Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining)
  3. Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer.
  4. 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:

  1. Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females.
  2. Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment.
  3. History of cancer, including anal cancer (with the exception of basal cell or squamous cell carcinoma of the skin), or currently undergoing treatment for any skin cancer.
  4. History of genital herpes with > 3 outbreaks per year.
  5. Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202992


Locations
United States, California
Research Center
San Francisco, California, United States, 94115
United States, Florida
Research Center
Orlando, Florida, United States, 32803
United States, Illinois
Research Center
Chicago, Illinois, United States, 60614
United States, New York
Research Center
New York, New York, United States, 10011
United States, North Carolina
Research Center
Winston-Salem, North Carolina, United States, 27157
Australia, Darlinghurst
Research Center
Sydney, Darlinghurst, Australia, 2010
Sponsors and Collaborators
Antiva Biosciences
Investigators
Study Chair: Clinical Operations Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may use the contacts provided below. For general i

Responsible Party: Antiva Biosciences
ClinicalTrials.gov Identifier: NCT03202992     History of Changes
Other Study ID Numbers: ABI-1968-201
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Virus Diseases
Papilloma
Anus Neoplasms
Squamous Intraepithelial Lesions of the Cervix
Papillomavirus Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases