Plus Therapeutics announces FDA clearance of its IND application for REYOBIQ

Plus Therapeutics (PSTV) announced that the U.S. Food and Drug Administration, FDA, has cleared its Investigational New Drug, IND, application for REYOBIQ for the treatment of pediatric patients with supratentorial recurrent, refractory, or progressive high-grade glioma, HGG, and ependymoma. The trial will be referred to as the ReSPECT-PBC trial and is funded by a $3.0M research grant from the U.S. Department of Defense. Phase 1/2a Trial Design Highlights: The Phase 1/2a trial is a two-part, single-arm, prospective study aimed at determining the maximum tolerated dose, safety, and tolerability of REYOBIQ in pediatric patients aged 6 to 21 years. Key elements of the trial design include: Phase 1a/b: This phase will enroll an estimated 24 patients using a modified 3+3 dose escalation scheme to establish the MTD and recommended Phase 2 dose. Safety assessment and alignment with the FDA will occur at defined intervals. Phase 2a: This phase will enroll approximately 32 patients at the RP2D to assess efficacy.