SNB-101 receives IND clearance from FDA for Ph 1b/2 trial in SCLC patients
“SN BioScience has revealed details of its Phase 1b/2 clinical trial for SNB-101, targeting patients diagnosed with Extensive Stage Small Cell Lung Cancer (ES-SCLC). The trial will concentrate on dose escalation and optimization to improve both efficacy and safety. Approximately 55 patients will be enrolled, with a focus on reflecting the racial diversity of the U.S. population. Furthermore, the study, aimed at supporting Phase 2 clearance in Europe, will be conducted across South Korea, the U.S., and Europe. Efficacy, safety, and pharmacokinetics will serve as the primary endpoints. Following the dose optimization phase, the company plans to assess SNB-101’s efficacy and safety in approximately 100 patients through a single-arm, single-dose, open-label monotherapy study. If the results are positive, SN BioScience targets early U.S. commercialization, with market entry expected as early as 2028.”
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