The 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

Lantern 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).

STAR-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.

The 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:

"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."