Safety and Efficacy of AIV001 on Low Risk Basal Cell Carcinoma

AiViva BioPharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Superficial Basal Cell Carcinoma; Nodular Basal Cell Carcinoma

Treatments: Drug: AIV001

Study type: Interventional

Funder types: Industry

Identifiers

NCT04470726

AIV001-C01

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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26 participants in 4 patient groups

AIV001 Treatment Dose 1

Experimental group

Description:

Intradermal/intratumoral, Dose 1

Treatment:

Drug: AIV001

AIV001 Treatment Dose 2

Experimental group

Description:

Intradermal/intratumoral, Dose 2

Treatment:

Drug: AIV001

AIV001 Treatment Dose 3

Experimental group

Description:

Intradermal/intratumoral, Dose 3

Treatment:

Drug: AIV001

AIV001 Treatment Dose 4

Experimental group

Description:

Intradermal/intratumoral, Dose 4

Treatment:

Drug: AIV001