The purpose of this trial is to evaluate safety, tolerability and efficacy of various doses of STP705 administered as intralesional injection in subjects with cutaneous squamous cell carcinoma (in situ) skin cancer (isSCC).
This is a two-part, double-blind, randomized, placebo-controlled study designed to evaluate safety and efficacy of various doses of STP705 administered as an intralesional injection in subjects with isSCC. A total of up to 100 eligible subjects will be enrolled. Enrolled subjects will be randomly allocated to receive STP705 or placebo injection once weekly for 6 weeks. After 6 weeks, the lesion will be excised. In part 1 (dose ranging study): 40 subjects will be randomized to receive 1 of the 3 STP705 doses or placebo. An interim analysis will be done after all subjects have completed end of treatment (EOT) visits to determine 2 selected dose levels of STP705 to be used in part of the study. In part 2: 60 additional subjects will be randomized to receive 1 of the 2 selected doses (from part 1) or placebo. In both parts at the End of Treatment (EOT), the lesion will be excised.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
The STP705 drug substance is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively.
Normal Saline
Investigate MD
Scottsdale, Arizona, United States
Center for Clinical and Cosmetic Research
Aventura, Florida, United States
Research Institute of the Southeast LLC
West Palm Beach, Florida, United States
Dermatology, Laser and Vein Specialists of the Carolinas
Charlotte, North Carolina, United States
Proportion of participants with histological clearance of treated isSCC lesion
Proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT).
Time frame: 6 weeks
Change in size of the treated isSCC lesion
Change in size of the treated isSCC lesion over the 6-week treatment period.
Time frame: 6 weeks
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Dermatology Associates of Knoxville
Knoxville, Tennessee, United States
Tennessee Clinical Research
Nashville, Tennessee, United States
Austin Institute for Clinical Research
Pflugerville, Texas, United States