Business
Lantern Pharma and Starlight Therapeutics Announce FDA Clearance of IND for a Planned Phase 1 Pediatric CNS Cancer Trial of STAR-001
The Planned Multicenter Phase 1 Trial Will Evaluate STAR-001 as Monotherapy and in Combination with Spironolactone in Children with Relapsed or Refractory
About this update from Lantern Pharma Inc.
[{"type":"text","content":"\nThe Planned Multicenter Phase 1 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\n\n\n DALLAS--(BUSINESS WIRE)--\nLantern Pharma Inc. (NASDAQ: LTRN) and its CNS-oncology focused wholly owned subsidiary Starlight Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for STAR-001 in a planned Phase 1 pediatric clinical trial (IND No. 179145).\n\n\nSTAR-001 is a precision oncology compound whose CNS and pediatric CNS indications were initially identified using Lantern's proprietary RADR® AI platform. The planned trial will evaluate STAR-001 as a single agent and in combination with spironolactone in pediatric patients with relapsed or refractory central nervous system (CNS) malignancies.\n\n\nThe trial is planned to be conducted in collaboration with POETIC — the Pediatric Oncology Experimental Therapeutics Investigators' Consortium — a multicenter network of 14 leading academic children's cancer centers across the United States, Canada, and Israel. The study protocol, as reviewed and cleared by the FDA, is titled:\n\n\n\"A PHASE 1, MULTICENTER, OPEN-LABEL, DOSE ESCALATION STUDY OF STAR-001 (LP-184) AS A SINGLE AGENT AND IN COMBINATION WITH SPIRONOLACTONE IN PEDIATRIC PATIENTS WITH RELAPSED OR REFRACTORY CENTRAL NERVOUS SYSTEM MALIGNANCIES.\"\n\n\nADDRESSING A CRITICAL UNMET NEED IN PEDIATRIC NEURO-ONCOLOGY\n\n\nPediatric CNS tumors represent one of the most devastating and treatment-resistant categories of childhood cancer. In the United States, an estimated 4,975 new cases of primary brain tumors will be diagnosed in children and adolescents in 2026 alone — making brain tumors the leading cause of cancer-related death among children and adolescents ages 0 to 19. The burden extends far beyond U.S. borders: globally, approximately 47,600 new pediatric CNS tumor cases are diagnosed each year, resulting in an estimated 23,500 deaths annually. Across Europe, the disease is similarly pervasive, with wide disparities in survival outcomes for children facing high-grade or relapsed cancers.\n\n\nDespite significant advances in molecular profiling and surgical technique over the past two decades, survival ou...