Safety and Efficacy of AIV001 on Low Risk Basal Cell Carcinoma

Study Overview
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Brief Summary
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To evaluate safety and efficacy of AIV001 treatment on low-risk basal cell carcinoma.

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

Conditions
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Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma

Intervention / Treatment
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* Drug: AIV001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18 to 80 years, inclusive No clinically relevant abnormalities identified by a detailed medical history and vital signs Presence of a histologically confirmed low risk BCC lesion, with well-defined borders, and with a largest diameter measure before biopsy of 5 mm to 20 mm, located on arms or trunk Histological diagnosis of the target lesion must have been conducted 5 to 30 days prior to Day 1 No other dermatological disease within 50 mm of the target lesion at Day 1 No prior or concurrent treatment of the target lesion (including radiation therapy) Willing to undergo surgical excision approximately 63 days after first treatment. Exclusion Criteria: History or presence of systemic cancer Prior radiation treatment at the lesion site or anywhere else on the body within the past 20 years Concurrent disease or treatment that suppresses the immune system (eg, previous organ transplant history, etc.) Clinically relevant cardiovascular, endocrine, hepatic, neurologic, renal, or other major systemic disease that could complicate execution of the protocol or interpretation of the study results. History of thrombotic events, hemorrhagic events, and gastrointestinal perforation and fistula History of recurrence or presence of any other tumor subtype in the target lesion Concurrent presence of a malignant lesion within 100 mm of the target lesion that will require treatment during the study Current enrollment in any other investigational drug or device study within 60 days of Day 1 of this study Evidence of dermatological disease or confounding dermatological condition that would hinder carrying out the study or interpreting the results (eg, atopic dermatitis, eczema, psoriasis, xeroderma pigmentosa, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIV001 Treatment Dose 1<br>Intradermal/intratumoral, Dose 1 | Drug: AIV001<br>* Intradermal/intratumoral<br>|
| Experimental: AIV001 Treatment Dose 2<br>Intradermal/intratumoral, Dose 2 | Drug: AIV001<br>* Intradermal/intratumoral<br>|
| Experimental: AIV001 Treatment Dose 3<br>Intradermal/intratumoral, Dose 3 | Drug: AIV001<br>* Intradermal/intratumoral<br>|
| Experimental: AIV001 Treatment Dose 4<br>Intradermal/intratumoral, Dose 4 | Drug: AIV001<br>* Intradermal/intratumoral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Incidence of adverse events | Approximately 119 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance of basal cell carcinoma | Number of participants cleared of basal cell carcinoma within study duration | Approximately 105 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nonmelanoma Skin Cancer, Keratinocyte Carcinoma, NMSC, BCC