To evaluate safety and efficacy of AIV001 treatment on low-risk Nonmelanoma Skin Caner of the basal cell carcinoma subtype.
AIV001 (axitinib) has been formulated to provide focal disease-modifying therapy for patients with nonmelanoma skin cancer (NMSC) of the basal cell carcinoma (BCC) subtype. AIV001 targets angiogenesis, inflammation, and fibrosis associated with various pathological skin conditions and was formulated as a simple intradermal/intratumoral injection demonstrating prolonged skin residence. Surgical excision is the standard treatment for NMSC of the basal cell carcinoma subtype for lesions of \< 20 mm. Surgical removal of lesions is effective but for some patients unwilling or contraindicated for surgery a nonsurgical option is needed. A nonsurgical option will eliminate post-surgical complications and scarring experienced after lesion removal. Also, specific anatomical location of lesions present cosmesis (i.e., face) or healing challenges (i.e., lower limbs). An effective injectable will benefit patients who are averse to surgery, at risk of wound healing complications or concerned with cosmesis outcomes or fatigued from multiple surgeries. Patient populations (i.e., elderly or patients with diabetes) who are at risk of delayed wound healing would benefit from an injectable option. This study will evaluate injection methods, interval of treatment, four ascending doses, safety, histological clearance and clinical clearance of biopsy-confirmed "low-risk" BCC lesion of \<20 mm located on non-facial skin.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Intradermal/intratumoral
AIV001 is administered as a aqueous suspension by an intradermal/intratumoral injection
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Island Dermatology
Newport Beach, California, United States
Skin Surgery Medical Group
San Diego, California, United States
Austin Institute for Clinical Research
Pflugerville, Texas, United States
Number of adverse events during study period
Incidence of adverse events
Time frame: Approximately 119 days
Percentage of Histological Clearance achieved of BCC treated lesion
full clearance is no residual BCC cells by histology
Time frame: Cohort 1-3 Day 63; Cohort 4 Day 105 or Day 126
Percentage of Clinical Clearance of treated basal cell carcinoma lesion on skin surface
Number of participants with no surface tumor visible in the study lesion on excision day
Time frame: Cohort 1-3 Day 63; Cohort 4 Day 105 or Day 126
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.