HSIL, High-Grade Squamous Intraepithelial LesionsPhase 1NCT03677960
Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
A Phase 1 study testing Topical ABI-1968 cream in people with HSIL, High-Grade Squamous Intraepithelial Lesions and Human Papilloma Virus Infection, run by Antiva Biosciences at 2 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?
- Topical ABI-1968 cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 Dec 2018to 30 Jun 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 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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)
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
- Being tested
- Topical ABI-1968 cream
- 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.
Topical ABI-1968 creamDrug
Multiple doses of Topical ABI-1968 Cream administered by the Investigator in the clinic up to Day 29
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 - Multiple Ascending Dose(MAD) | Experimental | Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic Receives: 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 Receives: 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 Receives: Drug: Topical ABI-1968 cream |
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: MAD portion is 84 days
Secondary outcomes (1)
Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.
Plasma concentrations of ABI-1968 over time
Measured: 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 posted19 Sep 2018
- Study start17 Dec 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Why it stopped: Pre-Clinical Toxicology Findings
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
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antiva Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677960
- Sponsor's protocol ID
- ABI-1968-202
- Status last verified
- Apr 2019
- First submitted
- 18 Sep 2018
- Last updated
- 24 Jul 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 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 Multiple Doses Of Topical Abi-1968 In Subjects With Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)
- ClinicalTrials.gov ID
- NCT03677960
- Acronym / sponsor ID
- ABI-1968-202
- Conditions
- HSIL, High-Grade Squamous Intraepithelial Lesions, Human Papilloma Virus Infection, HIV Infection, Anal Cancer, Anus Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pre-Clinical Toxicology Findings
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Antiva BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 19 Sep 2018 (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
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose 1 - Multiple Ascending Dose(MAD) | Experimental | Drug: Topical ABI-1968 creamMultiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic |
| Dose 2 - Multiple Ascending Dose(MAD) | Experimental | Drug: Topical ABI-1968 creamMultiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic |
| Dose 3 - Multiple Ascending Dose(MAD) | Experimental | Drug: Topical ABI-1968 creamMultiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic |
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 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.
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 |
|---|---|---|
| Topical ABI-1968 creamMultiple doses of Topical ABI-1968 Cream administered by the Investigator in the clinic up to Day 29 | Drug | Dose 1 - Multiple Ascending Dose(MAD), Dose 2 - Multiple Ascending Dose(MAD), Dose 3 - Multiple Ascending Dose(MAD) |
Primary outcome
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of aHSIL
Time frame: MAD portion is 84 days
Number of participants with Adverse Events related to treatment
1 secondary outcome
Systemic exposure to ABI-1968 Topical Cream following topical application to the anal canal.
Time frame: MAD portion is 84 days
Results and safety
The study was stopped early (reason given: Pre-Clinical Toxicology Findings). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 Topical ABI-1968 cream in people with HSIL, High-Grade Squamous Intraepithelial Lesions and Human Papilloma Virus Infection, run by Antiva Biosciences at 2 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: stopped early, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: Pre-Clinical Toxicology Findings). Results are not available in the source record.
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: 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 24 Jul 2019.