drugset / Trial / NCT04293679
Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With isSCC
RandomizedSequentialOpen-labelTreatment
Summary
This is an open label, dose escalation study to evaluate the safety and efficacy of intralesional injection of STP705 in adult patients with Cutaneous Squamous Cell Carcinoma in situ (isSCC, Bowen's disease). The purpose of this trial is to evaluate the safety, tolerability and efficacy of various doses of STP705 administered as Intralesional injection in subjects with isSCC. Goals: * To determine the safe and effective recommended dose of STP705 for the treatment of isSCC. * Analysis of biomarkers common to isSCC formation pathway including TGF-β1 and COX-2.
Timeline
- Start
- 2019-03-21
- Primary completion
- 2020-10-21
- Completion
- 2020-10-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | STP705 | Small interfering RNA (siRNA) | 10 ug | Other |
| Subject | STP705 | Small interfering RNA (siRNA) | 20 ug | Other |
| Subject | STP705 | Small interfering RNA (siRNA) | 30 ug | Other |
| Subject | STP705 | Small interfering RNA (siRNA) | 60 ug | Other |
| Subject | STP705 | Small interfering RNA (siRNA) | 120 ug | Other |