Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With Basal Cell Carcinoma
NCT04669808 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2024-03-18
Summary
This phase 2, open label, dose escalation study is designed to evaluate the safety, tolerability and efficacy of various doses of STP705 administered as localized injection in patients with Basal Cell Carcinoma (BCC).
Goals:
* To determine the safe and effective recommended dose of STP705 for the treatment of basal cell carcinoma.
* Analysis of biomarkers common to BCC formation pathway including TGF-β1 and COX-2.
Conditions
Interventions
- DRUG
-
STP705
Dry powder for intra-and peri-lesional injection.
Sponsors & Collaborators
-
Amarex Clinical Research
collaborator OTHER -
Sirnaomics
lead INDUSTRY
Principal Investigators
-
Mark Nestor, MD, PhD · Center for Clinical and Cosmetic Research
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-28
- Primary Completion
- 2023-02-09
- Completion
- 2023-02-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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