Clinical Trial to Evaluate BO-112 in Patients with Basal Cell Carcinoma (BCC)
Status:
RECRUITING
Trial end date:
2028-06-01
Target enrollment:
Participant gender:
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 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.