Clinical Trial to Evaluate BO-112 in Patients With Basal Cell Carcinoma (BCC)
NCT ID: NCT06422936
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2024-05-27
2028-06-30
Brief Summary
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* primary endpoint is 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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort I
patients with low risk nodular BCC
BO-112
Noncoding double-stranded (ds) RNA based on polyinosinic-polycytidylic acid (Poly I:C), formulated with polyethylenimine (PEI) for intra-lesional injection
Cohort II
patients with high risk BCC
BO-112
Noncoding double-stranded (ds) RNA based on polyinosinic-polycytidylic acid (Poly I:C), formulated with polyethylenimine (PEI) for intra-lesional injection
Interventions
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BO-112
Noncoding double-stranded (ds) RNA based on polyinosinic-polycytidylic acid (Poly I:C), formulated with polyethylenimine (PEI) for intra-lesional injection
Eligibility Criteria
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Inclusion Criteria
Type of Participant and Disease Condition
2. Has primary resectable low or high risk basal cell carcinoma according to the protocol definition
3. Has diagnostic punch biopsy of all lesions intended for injection available prior to the first dose of BO-112.
4. Has adequate organ function defined as defined per protocol
5. 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.
6. 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.
7. 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
8. 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.
9. Able and willing to comply with all study requirements, including surgical removal of lesion/lesion site at completion of study.
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Highlight Therapeutics
INDUSTRY
Responsible Party
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Locations
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Soroka Medical Center
Beersheba, , Israel
Rambam Medical Center
Haifa, , Israel
Hadassah Ein Kerem Medical Center
Jerusalem, , Israel
Kaplan Medical Center
Rehovot, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Hospital Clínic Barcelona
Barcelona, , Spain
Hospital de Basurto
Bilbao, , Spain
Clínica Universitaria de Navarra (CUN)
Madrid, , Spain
Complejo Asistencial Universitario de Salamanca
Salamanca, , Spain
Instituto Valenciano de Oncología (IVO)
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Adi Saadia, MD
Role: primary
Michal Ramon, MD
Role: primary
Sharon Merims, MD
Role: primary
Other Identifiers
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BOT-112-204
Identifier Type: -
Identifier Source: org_study_id