NCT06011109 · Aveta Biomics, Inc.
Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab
What this study is about
The goal of this interventional study is to evaluate the effectiveness of APG-157 in combination with Bevacizumab in subjects with recurrent high-grade glioma.
View original scientific 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.
Interventions
DRUG
APG-157
The participants will receive APG-157 daily; and continue to receive Bevacizumab as standard of care.
Primary outcome measures
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
To evaluate progression-free survival of participants with recurrent high-grade glioma treated with APG-157 and Bevacizumab. Progression of the disease will be assessed using commonly used imaging modality such as Magnetic Resonance Imaging or CT scan.
Overall Survival
Time frame: From date of commencement of treatment until the date of death from any cause. Duration of assessment will be 12 months from the date of commencement of the treatment.
To evaluate overall survival of participants with recurrent high-grade glioma treated with APG-157 and Bevacizumab
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 Status/Age: Patients must be 19 years of age or older (the age of consent in Nebraska.) 5. Patients must have recovered from any toxicity of prior therapy to Grade 1 or less. 6. ECOG Performance Status of 0-3. 7. Patients must have an adequate bone marrow reserve (ANC count ≥1,500/mm3, hemoglobin \> 8 g/dL, platelet count ≥100,000/mm3). 8. Patients must have adequate renal and hepatic function with
Where
- Rochester, Minnesota
- Omaha, Nebraska
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations