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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06011109
Study type Interventional
Source Aveta Biomics, Inc.
Contact Nicole Shonka, MD
Phone 402-559-3881
Email nshonka@unmc.edu
Status Recruiting
Phase Phase 1/Phase 2
Start date December 13, 2023
Completion date January 31, 2025

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