Evaluating BO-112 for treating Basal Cell Carcinoma
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 study is testing if injecting a new treatment called BO-112 directly into tumors can help people with basal cell carcinoma by improving their chances of recovery after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Highlight Therapeutics Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, prednisone |
| Locations | 10 sites (Be'er Sheva and 9 other locations) |
| Trial ID | NCT06422936 on ClinicalTrials.gov |
What this trial studies
This multicenter, phase 2b clinical trial aims to assess the safety, tolerability, pharmacodynamics, and preliminary efficacy of intra-lesional BO-112 in patients with resectable primary basal cell carcinoma (BCC). The study will evaluate the complete visual and pathological response at surgery, alongside monitoring adverse events and recurrence rates over 12 and 24 months post-surgery. Participants will receive BO-112 injections directly into their tumors, and outcomes will be assessed through central review and investigator evaluations.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with primary resectable low or high-risk basal cell carcinoma.
Not a fit: Patients with non-resectable basal cell carcinoma or those who do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with basal cell carcinoma, potentially improving surgical outcomes and reducing recurrence rates.
How similar studies have performed: While this approach is being evaluated in this specific context, similar immunotherapy strategies have shown promise in treating various cancers, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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 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: 1. Has history of hypersensitivity to BO-112 or its excipients/vehicle. 2. Has any BCC lesion(s) in site of prior radiation and/or any BCC lesion(s) within 2 cm of the open eyelid margins 4. Has Gorlin's syndrome 5. Has clinically active or uncontrolled skin disease or tattoos that would interfere with evaluation of the area surrounding the target lesion 6. Has another malignant disease requiring treatment 7. 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. 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
Where this trial is running
Be'er Sheva and 9 other locations
- Soroka Medical Center — Be'er Sheva, Israel (Recruiting)
- Rambam Medical Center — Haifa, Israel (Recruiting)
- Hadassah Ein Kerem Medical Center — Jerusalem, Israel (Recruiting)
- Kaplan Medical Center — Rehovot, Israel (Recruiting)
- Sourasky Medical Center — Tel Aviv, Israel (Recruiting)
- Hospital Clínic Barcelona — Barcelona, Spain (Recruiting)
- Hospital de Basurto — Bilbao, Spain (Recruiting)
- Clínica Universitaria de Navarra (CUN) — Madrid, Spain (Not_yet_recruiting)
- Complejo Asistencial Universitario de Salamanca — Salamanca, Spain (Not_yet_recruiting)
- Instituto Valenciano de Oncología (IVO) — Valencia, Spain (Not_yet_recruiting)
Study contacts
- Study coordinator: Marisol Quintero, PhD
- Email: mquintero@highlighttherapeutics.com
- Phone: +34 682 544 814
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.