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RECRUITING
NCT06724926
PHASE1

Concurrent Azeliragon With Craniospinal Irradiation

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

Summary

Single institution study to assess the safety of concurrent Azeliragon with craniospinal irradiation (CSI) in patients with leptomeningeal metastasis from solid tumor malignancies and high-grade gliomas.

Official title: A Phase IB Study to Assess Safety of Concurrent Azeliragon With Craniospinal Irradiation in Patients With Leptomeningeal Metastasis From Solid Tumor Malignancies or High-Grade Gliomas

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-02-18

Completion Date

2031-01

Last Updated

2026-01-02

Healthy Volunteers

No

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.

Locations (1)

NYU Langone Health

New York, New York, United States