A Pilot Study of APG-157 With Bevacizumab for Patients With Recurrent High-Grade Glioma
Aveta Biomics, Inc.
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.
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 indic…
Eligibility
- Age range
- 19+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must have pathologically proven diagnosis of high grade (aka grade III or IV) glioma that has progressed on bevacizumab (anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, gliosarcoma, H3K27M mutant glioma). 2. Patients must have received prior radiation therapy and standard temozolomide. Patients who have received any number of therapies for previous progressions will be considered eligible. 3. Patients must be three or more months from the end of chemoradiotherapy or have biopsy or imaging consistent with disease progression. 4. Physiologic S…
Interventions
- DrugAPG-157
The participants will receive APG-157 daily; and continue to receive Bevacizumab as standard of care.
Locations (2)
- Mayo ClinicRochester, Minnesota
- University of Nebraska Medical CenterOmaha, Nebraska