Clinical trial · Interventional
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection.
An Open-Label Multiple-Dose, Dose Escalation Study To Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Participants With Cervical High Grade Squamous Intraepithelial Lesions
NCT03697226CI-TRIAL-00049399completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the use of ABI-1968, a topical cream, in the treatment of cervical precancerous lesions in females without human immunodeficiency virus (HIV) infection.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Cervical Neoplasm | Cervical Neoplasm | ONTOLOGY_EXACT | 0.98 |
| CIN - Cervical Intraepithelial Neoplasia | — | UNRESOLVED | — |
| High-Grade Cervical Intraepithelial Neoplasia | High Grade Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| HIV Negative | — | UNRESOLVED | — |
| HSIL, High Grade Squamous Intraepithelial Lesions | High Grade Squamous Intraepithelial Neoplasia | ALIAS | 0.85 |
| HSIL of Cervix | High Grade Cervical Squamous Intraepithelial Neoplasia | ALIAS | 0.90 |
| Human Papilloma Virus | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Topical ABI-1968 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Dose 1
- description
- Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22
- interventionNames
- Drug: Topical ABI-1968
- type
- EXPERIMENTAL
- label
- Dose 2
- description
- Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22
- interventionNames
- Drug: Topical ABI-1968
- type
- EXPERIMENTAL
- label
- Dose 3
- description
- New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women, 25 to 50 years old. 2. Biopsy-confirmed cervical HSIL that is p16+ within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen. 3. Colposcopy is satisfactory based on visualization of the entire squamo-columnar junction (SCJ). The borders of all lesions must be completely visible. 4. The upper limit of the visible (usually aceto-white) lesion is within 3 quadrants or less at screening. Exclusion Criteria: 1. Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females. 2. HIV positive (tested at screening visit or within 3 months of screening visit). 3. Resolution of visible CIN lesion prior to enrollment. 4. ECC positive for glandular disease (adenocarcinoma in situ) or invasive cancer. 5. History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.
References
Publications (0)
Data not yet available
No reference posted for this study.