Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorAveta Biomics, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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).
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.
Patients must be three or more months from the end of chemoradiotherapy or have biopsy or imaging consistent with disease progression.
Physiologic Status/Age: Patients must be 19 years of age or older (the age of consent in Nebraska.)
Disqualifiers
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of oral APG-157, or put the study outcomes at undue risk
Immunotherapy, chemotherapy, radiotherapy, or experimental therapy within one full cycle period before first dose of study drug (i.e., for lomustine 6 weeks, for temozolomide 4 weeks)
Lactating or pregnant
History of uncontrollable allergic reactions to bevacizumab
Trial design
Treatments tested in this trial
- APG-157
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
2Mayo Clinic55905, RochesterMinnesota, United States
University of Nebraska Medical Center68198, OmahaNebraska, United States
Sponsors and collaborators
Aveta Biomics, Inc.
Lead sponsor
Source ClinicalTrials.gov