NCT06724926

Concurrent Azeliragon With Craniospinal Irradiation

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor
• High-grade Glioma
• Leptomeningeal Metastasis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-18
• Primary completion: 2027-01-01
• Completion: 2031-01-01
• First posted: 2024-12-09
• Last updated: 2026-01-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study