Concurrent Azeliragon With Craniospinal Irradiation

PHASE1RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

February 19, 2025

Primary Completion Date

January 31, 2027

Study Completion Date

January 31, 2031

Conditions
Solid TumorHigh-grade GliomaLeptomeningeal Metastasis
Interventions
DRUG

Azeliragon

"Azeliragon is orally administered. Patients start Azeliragon 7 days before CSI and take their last dose 7 days post-CSI.~The first 6 patients will start at Dose Level 1 \[DL1\] (Loading dose for 7 days: 30 mg twice daily; Concurrent/adjuvant dose: 20 mg once daily).~If 1 or fewer of 6 patients develop dose-limiting toxicity (DLT) then the recommended dose will be DL1. If at least 2 of 6 develops a DLT, then an additional 6 patients will be enrolled at Dose Level -1 \[DL-1\] (Loading dose for 7 days: 15mg twice daily; Concurrent/adjuvant dose: 10mg once daily).~If 1 or fewer out of 6 patients at DL-1 develop DLT, then the recommended dose will be DL-1. If at least 2 of 6 at DL-1 develops a DLT, then an additional 6 patients will be enrolled at Dose Level -2 \[DL-2\] (Loading dose for 7 days: 15mg twice daily; Concurrent/adjuvant dose: 5mg once daily).~At the recommended dose, an additional 14 patients will be enrolled for the Dose Expansion portion."

PROCEDURE

CSI

Patients will receive CSI.

Trial Locations (1)

10016

RECRUITING

NYU Langone Health, New York

All Listed Sponsors
lead

NYU Langone Health

OTHER