Plus Therapeutics announced on June 25, 2025, that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application (No. 168178) for REYOBIQ™. This clearance is for the treatment of pediatric patients with supratentorial recurrent, refractory, or progressive high-grade glioma (HGG) and ependymoma.
The trial, to be known as ReSPECT-PBC, is a two-part, single-arm, prospective Phase 1/2a study. It is designed to determine the maximum tolerated dose (MTD), safety, and tolerability of REYOBIQ in pediatric patients aged 6 to 21 years.
This initiative is significantly supported by a $3.0 million research grant from the U.S. Department of Defense. The clearance offers hope for children with aggressive and difficult-to-treat brain cancers, building on promising preclinical and adult clinical data.
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