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

This study will be conducted in patients with resectable primary low- and high-risk basal cell carcinoma according to the following definition:

Low-risk nodular BCC and/or low-risk superficial BCC:

• Participants with primary resectable nodular and/or superficial BCC with well-defined borders with:

• At least one lesion with the longest diameter from 5 to 10 mm located on cheeks, forehead, scalp, neck, and pretibial. OR
• At least one lesion with the longest diameter from 5 to 20 mm located on trunk and extremities (excluding hands, feet, nail units, pretibial, and ankles).

High-risk BCC:

• Participants with primary resectable aggressive BCC (i.e. having morpheaform, basosquamous (metatypical), sclerosing, mixed infiltrative, or micronodular features in any portion of the lesion) with:

• At least one lesion with the longest diameter from 5 mm to 30 mm in any body location. OR
• Participants with primary resectable nodular and/or superficial BCC with

• At least one lesion with the longest diameter from 5 mm to 30 mm located on central face, nose, lips, chin, mandible, preauricular and postauricular skin/sulci, temple, ear, genitalia, hands, and feet OR
• At least one lesion larger than 10 mm to 30 mm located on cheeks, forehead, scalp, neck, and pretibial OR
• At least one lesion larger than 20 mm to 30 mm located on trunk and extremities.

For all participants: lesion(s) intended to be injected must be at least 2 cm apart from the open eyelid margins.

Participants with multiple lesions in both groups must have a diagnostic punch or incisional biopsy from all lesions intended for injection and all lesions intended for injection must be resectable and injectable.

Inclusion criteria

• Participant must be ≥ 18 years old [or the legal age of consent in the jurisdiction in which the study is taking place], at the time of signing the informed consent.

Type of Participant and Disease Condition

• Has primary resectable low or high risk basal cell carcinoma according to the protocol definition
• Has diagnostic punch biopsy of all lesions intended for injection available prior to the first dose of BO-112.
• Has adequate laboratory values as defined per protocol

Sex and Contraceptive/Barrier Requirements

• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study drug.
• Women of childbearing potential must be willing to use two effective methods of birth control while treated with BO-112 and for 4 weeks after the last treatment. The two forms of birth control authorized are defined as the use of a barrier method of contraception (condom with spermicide) in association with one of the following methods of birth control: bilateral tubal ligation; combined oral contraceptives (estrogens and progesterone) or implanted or injectable contraceptives from the time of informed consent.
• Male patients with female partners of childbearing potential must be willing to use two adequate contraception methods while treated with BO-112 and for 4 weeks after treatment completion.

Informed Consent

• Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Able and willing to comply with all study requirements, including surgical removal of lesion/lesion site at completion of study.

Exclusion criteria

• Has history of hypersensitivity to BO-112 or its excipients/vehicle.
• Has any BCC lesion(s) planned for injection in site of prior radiation within 6 months prior to first dose of BO-112.
• Has any BCC lesion(s) planned for injection within 2 cm of the open eyelid margins
• Has Gorlin's syndrome
• Has clinically active or uncontrolled skin disease or tattoos that would interfere with evaluation of the area surrounding the target lesion
• Has another malignant disease requiring treatment
• 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.
• Female participants: lactating or pregnant.
• 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.
• Is immunocompromised. Systemic corticosteroids at >10 mg/day prednisone or equivalent within 1 week prior to the first dose of BO-112.
• 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.
• Has any experimental or investigational agents within one month of first BO-112 injection.
• 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.
• 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.
• 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.
• Has any medical contraindications to surgery