Clinical Trial to Evaluate BO-112 in Patients With Basal Cell Carcinoma (BCC)

Exclusion Criteria

• •1\. Has history of hypersensitivity to BO-112 or its excipients/vehicle. 2. Has any BCC lesion(s) in site of prior radiation and/or any BCC lesion(s) within 2 cm of the open eyelid margins 4. Has Gorlin's syndrome 5. Has clinically active or uncontrolled skin disease or tattoos that would interfere with evaluation of the area surrounding the target lesion 6. Has another malignant disease requiring treatment 7. Has a history of immunological disorder, severe allergic reaction, moderate or severe asthma or known history of anaphylaxis or any other serious adverse reactions to the investigational products.
• •8\. Female participants: lactating or pregnant. 9. Has received a live vaccine or messenger ribonucleic acid (mRNA) Corona virus disease (COVID) vaccine within 7 days prior to the first dose of study drug or has a vaccination planned during treatment with BO-112 and within 7 days after the last study drug administration.
• •10\. Is immunocompromised. Systemic corticosteroids at \>10 mg/day prednisone or equivalent within 1 week prior to the first dose of BO-112.
• •11\. Has any prior systemic anti-lesion therapy or local treatment for study lesions prior to first dose; any chemotherapy or immunotherapy for any other malignancy within 24 months prior to the first dose of BO-112.
• •12\. Has any experimental or investigational agents within one month of first BO-112 injection.
• •13\. Has received or is expected to receive treatment with psoralen plus ultraviolet A (UVA) or ultraviolet B (UVB) therapy within 6 months prior to the first dose of BO-112.
• •14\. Requires / or has used topical products within 5 cm of a treatment-targeted BCC lesion or systemic therapies that might interfere with the evaluation of the study medication during the study.
• •15\. Has any other concurrent anti-cancer therapy (chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational \[used for a not approved indication and in the context of a research investigation\]) within 28 days of first study drug administration; or plans to participate in an experimental drug study while enrolled in this study.
• •16\. Has any medical contraindications to surgery