POLYINOSINIC:POLYCYTIDYLIC ACID for Basal cell carcinoma

Inclusion criteria

• {"criterion_text":"- Must be ≥ 18 years old\n- Has primary resectable low or high risk basal cell carcinoma according to the protocol definition\n- Has diagnostic punch biopsy or incisional biopsy of all lesions intended for injection available prior to the first dose of BO-112\n- Has adequate organ function as defined in the protocol\n- 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\n- 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\n- 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\n- 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\n- Able and willing to comply with all study requirements, including surgical removal of lesion/lesion site at completion of"}

Exclusion criteria

• {"criterion_text":"- Has any BCC lesion(s) planned for injection in site of prior radiation within 6 months prior to the first dose of BO-112 or has any BCC lesion(s) planned for injection within 2 cm of the open eyelid margins\n- Has any medical contraindications to surgery\n- Has Gorlin’s syndrome\n- Has clinically active or uncontrolled skin disease or tattoos that would interfere with evaluation of the area surrounding the target lesion\n- Has another malignant disease requiring treatment, except for adequately treated carcinoma in situ of the breast or of the cervix, low grade prostate cancer on surveillance without any plans for treatment intervention other than hormonal therapy, or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms\n- 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\n- Has history of hypersensitivity to BO-112 or its excipients/vehicle\n- Female participants: lactating or pregnant\n- Has received a live vaccine or mRNA 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\n- Is immunocompromised\n- Has any prior systemic anti-lesion therapy 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\n- 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.\n- Has any experimental or investigational agents within one month of first BO-112 injection\n- Has received or is expected to receive treatment with psoralen plus UVA or UVB therapy within 6 months prior to the first dose of BO-112\n- 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"}

Primary endpoints

• {"endpoint_text":"- Composite visual and pathological response [at surgery] on patient level assessed by central review","definition_or_measurement_approach":"Assessed at surgery on patient level by central review (visual and pathological composite response)."}

Secondary endpoints

• {"endpoint_text":"- Occurrence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation or death on patient level","definition_or_measurement_approach":"Occurrence of AEs/SAEs and AEs leading to discontinuation or death measured at patient level (safety reporting)."}
• {"endpoint_text":"- Pathological response [at surgery] on patient level assessed by the investigator and central review, respectively. Visual response [during the study and at surgery] on patient level assessed by the investigator and central review, respectively.","definition_or_measurement_approach":"Pathological response at surgery and visual response during study and at surgery assessed on patient level by both investigator and central review."}
• {"endpoint_text":"- Recurrence [at 12 months] after surgery on patient level assessed by the investigator","definition_or_measurement_approach":"Recurrence assessed by investigator at 12 months after surgery on patient level."}

Spain

Earliest CTIS Part Ii Submission Date

04-07-2024

Latest Decision Or Authorization Date

02-02-2026

Processing Time Days

578

Number Of Sites

6

Number Of Participants

30

Primary sponsor

Full Name

Highlight Therapeutics S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain