HSIL, High-Grade Squamous Intraepithelial LesionsPhase 1NCT03202992
Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
A Phase 1 study testing ABI-1968 in people with HSIL, High-Grade Squamous Intraepithelial Lesions and Human Papilloma Virus Infection, run by Antiva Biosciences at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 27 years and older
- Conditions the study is for
- HSIL, High-Grade Squamous Intraepithelial Lesions, Human Papilloma Virus Infection, HIV Infection
- What is being tested?
- ABI-1968
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 11 Aug 2017to 4 Feb 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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, including anal cancer (with the exception of basal cell or squamous cell carcinoma of the skin), or currently undergoing treatment for any skin cancer.
- History of genital herpes with > 3 outbreaks per year.
- Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Research Center
Chicago, Illinois, 60614
Research Center
New York, New York, 10011
Research Center
Orlando, Florida, 32803
Research Center
San Francisco, California, 94115
Research Center
Winston-Salem, North Carolina, 27157
About this study
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)
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 Neoplasms
- Being tested
- ABI-1968
- Medical subject headings
- Squamous Intraepithelial Lesions, Papillomavirus Infections, HIV Infections, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-1968Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 -Single Ascending Dose (SAD) | Experimental | SAD Dose Level 1 of ABI-1968 topical cream applied on Day 1 of the study Receives: Drug: ABI-1968 |
| Dose 2 -Single Ascending Dose (SAD) | Experimental | SAD Dose Level 2 of ABI-1968 topical cream applied on Day 1 of the study Receives: Drug: ABI-1968 |
| Dose 3 -Single Ascending Dose(SAD) | Experimental | SAD Dose Level 3 of ABI-1968 topical cream applied on Day 1 of the study Receives: Drug: ABI-1968 |
| Dose 4 -Single Ascending Dose(SAD) | Experimental | SAD Dose Level 4 of ABI-1968 topical cream applied on Day 1 of the study Receives: Drug: ABI-1968 |
| Dose 5 -Single Ascending Dose(SAD) | Experimental | SAD Dose Level 5 of ABI-1968 topical cream applied on Day 1 of the study Receives: Drug: ABI-1968 |
| Dose 1 - Multiple Ascending Dose(MAD) | Experimental | MAD Dose Level 1 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29 Receives: Drug: ABI-1968 |
| Dose 2 -Multiple Ascending Dose(MAD) | Experimental | MAD Dose Level 2 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29 Receives: Drug: ABI-1968 |
| Dose 3 -Multiple Ascending Dose(MAD) | Experimental | MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29 Receives: Drug: ABI-1968 |
| Multiple Ascending Dose (MAD) Cohort Expansion | Experimental | MAD Cohort Expansion of ABI-1968 applied at Day 1, Day 8, Day 15, Day 22 and Day 29 Receives: Drug: ABI-1968 |
| Dose 4-Multiple Ascending Dose(MAD) | Experimental | MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29 Receives: Drug: ABI-1968 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL
Number of participants with Adverse Events related to treatment
Measured: SAD portion is 29 days/MAD portion is 84 days
Secondary outcomes (2)
Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.
Plasma concentrations of ABI-1968 over time
Measured: SAD portion is 29 days/MAD portion is 84 days
Histopathology of areas with biopsy-proven disease following single and multiple doses of ABI-1968 Topical Cream.
Number of subjects with complete and or partial regression of aHSIL by High Resolution Anoscopy (HRA) and histopathology
Measured: SAD portion is 29 days/MAD portion is 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start11 Aug 2017
- Primary completion4 Feb 2019
- Study completion4 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HSIL, High-Grade Squamous Intraepithelial LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antiva Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Operations, Study chair, 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202992
- Sponsor's protocol ID
- ABI-1968-201
- Status last verified
- Feb 2019
- First submitted
- 24 Jun 2017
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03202992
- Acronym / sponsor ID
- ABI-1968-201
- Conditions
- HSIL, High-Grade Squamous Intraepithelial Lesions, Human Papilloma Virus Infection, HIV Infection, Anal Cancer, Anus Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Antiva BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 10
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dose 1 -Single Ascending Dose (SAD) | Experimental | Drug: ABI-1968SAD Dose Level 1 of ABI-1968 topical cream applied on Day 1 of the study |
| Dose 2 -Single Ascending Dose (SAD) | Experimental | Drug: ABI-1968SAD Dose Level 2 of ABI-1968 topical cream applied on Day 1 of the study |
| Dose 3 -Single Ascending Dose(SAD) | Experimental | Drug: ABI-1968SAD Dose Level 3 of ABI-1968 topical cream applied on Day 1 of the study |
| Dose 4 -Single Ascending Dose(SAD) | Experimental | Drug: ABI-1968SAD Dose Level 4 of ABI-1968 topical cream applied on Day 1 of the study |
| Dose 5 -Single Ascending Dose(SAD) | Experimental | Drug: ABI-1968SAD Dose Level 5 of ABI-1968 topical cream applied on Day 1 of the study |
| Dose 1 - Multiple Ascending Dose(MAD) | Experimental | Drug: ABI-1968MAD Dose Level 1 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29 |
| Dose 2 -Multiple Ascending Dose(MAD) | Experimental | Drug: ABI-1968MAD Dose Level 2 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29 |
| Dose 3 -Multiple Ascending Dose(MAD) | Experimental | Drug: ABI-1968MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29 |
| Multiple Ascending Dose (MAD) Cohort Expansion | Experimental | Drug: ABI-1968MAD Cohort Expansion of ABI-1968 applied at Day 1, Day 8, Day 15, Day 22 and Day 29 |
| Dose 4-Multiple Ascending Dose(MAD) | Experimental | Drug: ABI-1968MAD Dose Level 3 of ABI-1968 topical cream applied at Day 1, Day 8, Day 15, Day 22 and Day 29 |
Who may qualify
- Ages
- 27 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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, including anal cancer (with the exception of basal cell or squamous cell carcinoma of the skin), or currently undergoing treatment for any skin cancer.
- History of genital herpes with > 3 outbreaks per year.
- Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABI-1968Topical 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 | Drug | Dose 1 - Multiple Ascending Dose(MAD), Dose 1 -Single Ascending Dose (SAD), Dose 2 -Multiple Ascending Dose(MAD), Dose 2 -Single Ascending Dose (SAD), Dose 3 -Multiple Ascending Dose(MAD), Dose 3 -Single Ascending Dose(SAD), Dose 4 -Single Ascending Dose(SAD), Dose 4-Multiple Ascending Dose(MAD), Dose 5 -Single Ascending Dose(SAD), Multiple Ascending Dose (MAD) Cohort Expansion |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Operations study chair
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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABI-1968 in people with HSIL, High-Grade Squamous Intraepithelial Lesions and Human Papilloma Virus Infection, run by Antiva Biosciences at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL (time frame: SAD portion is 29 days/MAD portion is 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.