Clinical trial · Interventional
Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN)
Phase 2a Dose-Rising, Safety, Tolerability, and Efficacy Study of Topical SOR007 for Cervical Intraepithelial Neoplasia (CIN)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study never initiated
Summary
Brief summary (as posted)
This is a Phase 2, open-label, dose-rising study evaluating the safety, tolerability, and preliminary efficacy of three concentrations of SOR007 ointment (0.15%, 1.0%, and 2.0%) applied topically once per week for four weeks to the ectocervix of subjects with high grade cervical intraepithelial neoplasia (CIN).
Conditions
Conditions (1)
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 Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- SOR007 0.15%
- description
- 1 mL of 0.15% SOR007 Ointment
- interventionNames
- Drug: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment
- type
- EXPERIMENTAL
- label
- SOR007 1.0%
- description
- 1 mL of 1.0% SOR007 Ointment
- interventionNames
- Drug: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment
- type
- EXPERIMENTAL
- label
- SOR007 2.0%
- description
- 1 mL of 2.0% SOR007 Ointment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent; * Female adults ≥ 18 years of age; * Presence of newly diagnosed (within 8 weeks prior to administration of SOR007), histologically confirmed CIN 2, CIN 2/3 or CIN 3; * Candidate for observation, treatment, or removal of CIN; * Satisfactory colposcopy (visualization of the entire squamocolumnar junction and margins of any visible lesions); * Appropriate contraception throughout study period; Exclusion Criteria: * Pap smear and/or colposcopy suspicious for invasive disease; * History of previous conization/LEEP; * History of toxic shock syndrome; * Known allergy or prior intolerance to paclitaxel; * Immunodeficiency (including HIV/AIDS and immunosuppressive medication); * Current, reported participation in another experimental, interventional protocol; * Active lower genital infection(s); * Malignant disease at the time of inclusion, with the exclusion of basal cell carcinoma (BCC) or dermal carcinoma-in-situ; * Concurrent treatment with cytotoxic, radiation, immune-stimulative, or immune-suppressive therapy, or with systemic corticosteroid dose of \> 5 mg/d or prednisone (or its equivalent); * Concomitant use of topical vaginal medications or products; * Pregnant or lactating; * Pregnancy planned within six (6) months following study drug application; * Significant acute or chronic medical or psychiatric illness or other environmental or social factors that, in the opinion of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study
References
Publications (0)
Data not yet available