NCT04470726

Safety and Efficacy Evaluation of AIV001 in Nonmelanoma Skin Cancer of the Low Risk Basal Cell Carcinoma Subtype

An Exploratory Study to Evaluate the Safety and Efficacy of AIV001 Intradermally Administered in Subjects With Biopsy-confirmed Basal Cell Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: AiViva BioPharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate safety and efficacy of AIV001 treatment on low-risk Nonmelanoma Skin Caner of the basal cell carcinoma subtype.

Detailed description

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.

Conditions

• Superficial Basal Cell Carcinoma
• Nodular Basal Cell Carcinoma
• Nonmelanoma Skin Cancers

Interventions

Type	Name	Description
DRUG	AIV001	Intradermal/intratumoral
DRUG	AIV001 suspension	AIV001 is administered as a aqueous suspension by an intradermal/intratumoral injection

Timeline

• Start date: 2020-08-18
• Primary completion: 2023-06-20
• Completion: 2023-07-28
• First posted: 2020-07-14
• Last updated: 2024-12-27

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study