SPOTLIGHT 204: a Multicenter, Phase 2b, Open-label, Non-randomized, Clinical Trial to Evaluate Safety, Tolerability and Preliminary Efficacy of Intra-lesional BO-112 in Patients with Resectable Primary Low and High Risk Basal Cell Carcinoma
This is a multicenter, phase 2b, open-label, non-randomized, clinical trial to evaluate safety, tolerability, pharmacodynamics and preliminary efficacy of intra-lesional BO-112 in patients with resectable primary low and high risk basal cell carcinoma. * primary endpoint is complete visual and pathological response \[at surgery\] on patient level assessed by central review * secondary endpoints are 1. Occurrence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation or death on patient level. 2. Pathological response \[at surgery\] on patient level assessed by the investigator and central review, respectively, and visual response \[during the study and at surgery\] on patient level assessed by the investigator and central review, respectively. 3. Recurrence \[at 12 and 24 months\] after surgery on patient level assessed by the investigator.
• 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 organ function defined as defined per protocol
• 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.