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

NCT04470726 | Completed Phase 1 FDA Drug

• 1 other identifier: AIV001-C01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

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

Keywords

Nonmelanoma Skin Cancer; Keratinocyte Carcinoma; NMSC; BCC; basal cell carcinoma

Outcome Measures

Primary Outcomes (2)

• Number of adverse events during study period

  Incidence of adverse events

  Approximately 119 days

• Percentage of Histological Clearance achieved of BCC treated lesion

  full clearance is no residual BCC cells by histology

  Cohort 1-3 Day 63; Cohort 4 Day 105 or Day 126

Secondary Outcomes (1)

• Percentage of Clinical Clearance of treated basal cell carcinoma lesion on skin surface

  Cohort 1-3 Day 63; Cohort 4 Day 105 or Day 126

Study Arms (4)

AIV001 Treatment Dose 1

EXPERIMENTAL

Intradermal/intratumoral, Dose 1

Drug: AIV001; Drug: AIV001 suspension

AIV001 Treatment Dose 2

EXPERIMENTAL

Intradermal/intratumoral, Dose 2

Drug: AIV001; Drug: AIV001 suspension

AIV001 Treatment Dose 3

EXPERIMENTAL

Intradermal/intratumoral, Dose 3

Drug: AIV001; Drug: AIV001 suspension

AIV001 Treatment Dose 4

EXPERIMENTAL

Intradermal/intratumoral, Dose 4

Drug: AIV001; Drug: AIV001 suspension

Interventions

AIV001 DRUG

Intradermal/intratumoral

AIV001 Treatment Dose 1; AIV001 Treatment Dose 2; AIV001 Treatment Dose 3; AIV001 Treatment Dose 4

AIV001 suspension DRUG

AIV001 is administered as a aqueous suspension by an intradermal/intratumoral injection

AIV001 Treatment Dose 1; AIV001 Treatment Dose 2; AIV001 Treatment Dose 3; AIV001 Treatment Dose 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• AiViva BioPharma, Inc.: lead

Study Sites (4)

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Island Dermatology

Newport Beach, California, 92660, United States

Location

Skin Surgery Medical Group

San Diego, California, 92117, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be treated once, twice or three times at 21 days interval and lesions examined at the end of the study investigators will evaluate the lesion surface area for clearance and excise the original lesion area for histological assessment.

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 14, 2020
• Study Start: August 18, 2020
• Primary Completion: June 20, 2023
• Study Completion: July 28, 2023
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

US (4)