Safety and Efficacy of AIV001 on Low Risk Basal Cell Carcinoma

Superficial Basal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04470726
• Other study ID #: AIV001-C01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 18, 2020
• Est. completion date: July 28, 2023

Study information

• Verified date: January 2024
• Source: AiViva BioPharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 28, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male or female, aged 18 to 80 years, inclusive

2. No clinically relevant abnormalities identified by a detailed medical history and vital signs

3. 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

4. Histological diagnosis of the target lesion must have been conducted 5 to 30 days prior to Day 1

5. No other dermatological disease within 50 mm of the target lesion at Day 1

6. No prior or concurrent treatment of the target lesion (including radiation therapy)

7. Willing to undergo surgical excision approximately 63 days after first treatment.

Exclusion Criteria:

1. History or presence of systemic cancer

2. Prior radiation treatment at the lesion site or anywhere else on the body within the past 20 years

3. Concurrent disease or treatment that suppresses the immune system (eg, previous organ transplant history, etc.)

4. 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.

5. History of thrombotic events, hemorrhagic events, and gastrointestinal perforation and fistula

6. History of recurrence or presence of any other tumor subtype in the target lesion

7. Concurrent presence of a malignant lesion within 100 mm of the target lesion that will require treatment during the study

8. Current enrollment in any other investigational drug or device study within 60 days of Day 1 of this study

9. 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.)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell
• Nodular Basal Cell Carcinoma
• Superficial Basal Cell Carcinoma

Intervention

Drug:
• AIV001
Intradermal/intratumoral

Locations

Country	Name	City	State
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	Island Dermatology	Newport Beach	California
United States	Austin Institute for Clinical Research	Pflugerville	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AiViva BioPharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Incidence of adverse events	Approximately 119 days
Secondary	Clearance of basal cell carcinoma	Number of participants cleared of basal cell carcinoma within study duration	Approximately 105 days