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

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.

Timeline

Start

2024-05-27

Primary completion

2026-06

Completion

2028-06

Drugs

Indications