NCT06422936

Clinical Trial to Evaluate BO-112 in Patients With Basal Cell Carcinoma (BCC)

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Highlight Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	BO-112	Noncoding double-stranded (ds) RNA based on polyinosinic-polycytidylic acid (Poly I:C), formulated with polyethylenimine (PEI) for intra-lesional injection

Timeline

• Start date: 2024-05-27
• Primary completion: 2026-06-01
• Completion: 2028-06-01
• First posted: 2024-05-21
• Last updated: 2026-01-26

Locations

10 sites across 2 countries: Israel, Spain

Regulatory

• FDA-regulated drug study