Basal Cell Skin Cancer Clinical Trials

• Patients with high risk, locally advanced histologically confirmed (non-metastatic, node negative, single or multifocal), BCC and amenable to intratumoral injection, not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board.

• Patients with at least one injectable and measurable cutaneous or subcutaneous lesion.

• Patients must not have received prior HHIs and checkpoint inhibitors systemic treatment.

• Patients may have received prior surgery and/or radiation therapy.

• Radiotherapy must have been previously administered for their locally advanced BCC, unless radiotherapy is contraindicated or inappropriate (e.g., hypersensitivity to radiation due to genetic syndrome such as Gorlin syndrome, limitations because of location of tumor, or cumulative prior radiotherapy dose). For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation.

• Patients must have a histologically confirmed disease that is considered to be inoperable or medical contraindication to surgery or radiotherapy, in the opinion of a Mohs dermatologic surgeon, head and neck surgeon, plastic surgeon or surgical/medical oncologist. Acceptable medical contraindications to surgery include:

‣ BCC that has recurred in the same location after two or more surgical procedures and curative resection is deemed unlikely;

⁃ Anticipated substantial morbidity and/or deformity from surgery (e.g., removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation);

⁃ Medical conditions predisposing to poor surgical outcome (e.g., diabetes with history of poor wound healing);

⁃ Other conditions considered to be medically contraindicating must be discussed with the Medical Monitor before enrolling the patient.

• Prior radiotherapy to the target lesions must be completed at least 4 weeks prior to first study drug administration, with all acute RT-related toxicities resolved to ≤ Grade 1.

• Male or female patients, who are capable of giving consent, age ≥ 18 years.

• ECOG Performance Status/WHO Performance Status ≤ 1.

• Hemoglobin \> 10.0 g/dL.

• Platelets \> 100 x 109/L.

• ALT and AST, GGT and Lipase ≤ 1.5 x the upper limit of normal (ULN).

• All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 5.0) Grade ≤ 1 unless otherwise specified.

• Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening. WOCBP must be using, from screening to three months following the last study drug administration, highly effective contraception methods, as defined by the Recommendations for contraception and pregnancy testing in clinical trials issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner.

• Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration.

• Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.