Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab
Part of paid clinical trials in Rochester, Minnesota.
- Sponsor
- Aveta Biomics, Inc.
- Study ID
- NCT06011109
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Glioblastoma Multiforme
- Glioma
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- APG-157 — DRUGThe participants will receive APG-157 daily; and continue to receive Bevacizumab as standard of care.
Study Details
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.
Key Dates
- Start date
- Dec 13, 2023
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2026
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: APG-157The participants will receive APG-157 daily by taking 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.
Primary Outcome Measure
Progression-free Survival [ Time Frame: From date of commencement of treatment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months ]
Central Contacts
- Nicole Shonka, MD402-559-3881
- Apar Ganti, MD
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 |
Find similar trials in Rochester, MN
Related Studies
- A Study Utilizing Escitalopram in Glioma PatientsPHASE2 · Recruiting · University of Nebraska · Omaha, Nebraska
- Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System MalignanciesRecruiting · Mayo Clinic · Rochester, Minnesota
- Evaluation of Hippocampal-Avoidance Using Proton Therapy in Low-Grade GliomaRecruiting · St. Jude Children's Research Hospital · Rochester, Minnesota
- SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)PHASE3 · Recruiting · Nuvation Bio Inc. · Birmingham, Alabama