ACNS1821: A Phase 1/2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG)
ACNS1821
What is the goal of the study?
Primary Aims (Dose-finding phase) To define toxicities and estimate the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of selinexor administered as an oral formulation in combination with standard of care radiation therapy (RT), to pediatric patients with newly diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG). (Efficacy phase) To estimate the event-free survival (EFS) distribution for DMG/HGG patients and overall survival (OS) distribution for DIPG patients associated with selinexor plus RT, followed by selinexor in patients with newly diagnosed HGG (H3 K27M-mutant DMG or H3 K27-wild type HGG) or DIPG, and to compare those outcomes to historical controls. Exploratory Aims To bank tumor specimens and body fluids (blood and cerebrospinal fluid) for future studies.
Who can participate in the study?
Please contact the study team listed below to learn more.