NCT06011109

Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab

A Pilot Study of APG-157 With Bevacizumab for Patients With Recurrent High-Grade Glioma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Aveta Biomics, Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The goal of this interventional study is to evaluate the efficacy of APG-157 in combination with Bevacizumab in subjects with recurrent high-grade glioma. The main questions the study aims to answer are: * Progression-free and overall survival of patients receiving this combination; * Quality of Life (QOL); and * Tumor response on imaging The participants will take APG-157 daily by dissolving two pastilles in their mouth at around breakfast, lunch and dinner time (total of six pastilles per day). The pastilles dissolve in the mouth. The participants will continue to receive Bevacizumab as standard of care.

Detailed description

The goal of this interventional study is to evaluate the efficacy of APG-157 in combination with Bevacizumab in subjects with recurrent high-grade glioma who have previously progressed on bevacizumab alone. The main questions the study aims to answer are: * Progression-free and overall survival of patients receiving this combination; * Quality of Life (QOL); and * Tumor response on imaging Additional aims include: * characterization of pharmacokinetics (PK) of APG-157 in the presence of bevacizumab; and * optionally serum changes in VEGF and HIF-1 alpha, if the study shows preliminary indication of efficacy The participants will take APG-157 daily by dissolving two pastilles in their mouth at around breakfast, lunch and dinner time (total of 6 pastilles per day). The pastilles dissolve in the mouth. The participants will continue to receive Bevacizumab and be present for scheduled visits and examinations as standard of care.

Conditions

• Glioma
• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	APG-157	The participants will receive APG-157 daily; and continue to receive Bevacizumab as standard of care.

Timeline

• Start date: 2023-12-13
• Primary completion: 2025-12-31
• Completion: 2026-01-31
• First posted: 2023-08-25
• Last updated: 2025-10-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study