CompletedPhase 1/2

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

United States26 participantsStarted 2020-08-18

Plain-language summary

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

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.
✕

Number of adverse events during study period

Timeframe: Approximately 119 days

Percentage of Histological Clearance achieved of BCC treated lesion

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

NCT IDNCT04470726

SponsorAiViva BioPharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-20

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.
✕