Lantern Pharma and Starlight Therapeutics Receive FDA Clearance for Phase 1 Pediatric CNS Cancer Trial of STAR-001.

Lantern Pharma and Starlight Therapeutics have received FDA clearance for an IND application for a planned Phase 1 pediatric CNS cancer trial of STAR-001. The trial will evaluate STAR-001 as monotherapy and in combination with spironolactone in children with relapsed or refractory CNS malignancies, including ATRT, DIPG, GBM, medulloblastoma, and ependymoma. The trial aims to address a critical unmet need in pediatric neuro-oncology, with an estimated 4,975 new cases of primary brain tumors diagnosed in children and adolescents in the US in 2026.