Clinical trial · Interventional
Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
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)
NCT03677960CI-TRIAL-00039693terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Pre-Clinical Toxicology Findings
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Anus Neoplasm | Anal Neoplasm | ALIAS | 0.90 |
| HIV Infection | — | UNRESOLVED | — |
| HSIL, High-Grade Squamous Intraepithelial Lesions | High Grade Squamous Intraepithelial Neoplasia | ALIAS | 0.85 |
| Human Papilloma Virus Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Topical ABI-1968 cream | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose 1 - Multiple Ascending Dose(MAD)
- description
- Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic
- interventionNames
- Drug: Topical ABI-1968 cream
- type
- EXPERIMENTAL
- label
- Dose 2 - Multiple Ascending Dose(MAD)
- description
- Multiple Doses of Topical ABI-1968 cream applied by the Investigator in the clinic
- interventionNames
- Drug: Topical ABI-1968 cream
- type
- EXPERIMENTAL
- label
- Dose 3 - Multiple Ascending Dose(MAD)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 27 Years
Show eligibility criteria text
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 involving the anogenital region, or history of other cancers that have not been fully resolved and free of symptoms in the past 5 years 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.
References
Publications (0)
Data not yet available
No reference posted for this study.