APG-157 and Bevacizumab for Recurrent High-Grade Glioma

This study is testing a new combination treatment for people with high-grade glioma (a type of brain tumor) that has returned after previous treatment. You would receive APG-157 daily, which are pastilles that dissolve in your mouth, along with your standard Bevacizumab treatment. Researchers want to see if this combination can help you live longer without the tumor growing (progression-free survival) and improve overall survival. They will also look at your quality of life and how the tumor responds on imaging scans. To join, you must be at least 19 years old, have a high-grade glioma that has progressed while on Bevacizumab, and have had prior radiation and temozolomide.

Study design
This is an interventional study with a planned enrollment of 30 participants. The phase of the study is not specified.
What's involved
You would take APG-157 pastilles three times a day (six pastilles total) and continue to receive Bevacizumab. You would also attend scheduled visits and examinations.
Compensation
Not stated in the trial record.
Follow-up
Researchers will assess progression-free survival and overall survival for up to 12 months from the start of treatment.

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NCT06011109

Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab

Recruiting
PHASE1Ages 19+InterventionalTreatment
Aveta Biomics, Inc.
~30 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:APG-157

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free Survival
Measured over 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
+1 more outcome measured
Glioma
Glioblastoma Multiforme
2 sites across 2 states
Minnesota1
Nebraska1
  • Nicole Shonka, MD · PRINCIPAL_INVESTIGATOR · University of Nebraska
  • Joon Uhm, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Exclusion

Inadequately controlled hypertension (i.e., systolic blood pressure (SBP) \> 160 mm Hg and/or diastolic blood pressure (DBP) \> 90 mm Hg despite antihypertensive therapy)
History of cerebrovascular accident (CVA) within 6 months
Myocardial infarction or unstable angina within 6 months 6. Evidence or history of bleeding diathesis (greater than normal risk of bleeding, i.e., Hereditary Hemorrhagic Telangiectasia type I or HHT-1) or coagulopathy in the absence of therapeutic anti-coagulation or any hemorrhage/bleeding event \> Grade 3 within 4 weeks prior to registration. Note: Patients with full-dose anticoagulants are eligible provided the patient has been on a stable dose for at least 2 weeks 7. Active wound, a serious or non-healing wound, an active ulcer or untreated bone fracture within the last two months. 8. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess ≤ 6 months prior to registration. 9. Major surgical procedure, open biopsy, or significant traumatic injury ≤ 28 days prior to registration 10. Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
  • Progression-free SurvivalFrom 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 SurvivalFrom 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