Could a daily pastille help fight recurrent brain tumors?
NCT ID NCT06011109
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests whether adding APG-157 (a pastille dissolved in the mouth) to standard bevacizumab can help people with recurrent high-grade glioma. About 30 participants will take APG-157 three times daily while continuing bevacizumab. The study tracks survival, tumor response on scans, and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- APG-157 (a pastille dissolved in the mouth) plus bevacizumab (standard of care)
- What this could lead to
- If it works, this combination could offer a new option to slow tumor growth and improve quality of life for patients with recurrent high-grade glioma.
- What could go wrong
- This is a small, early-phase pilot study with only 30 participants, so results may not apply broadly. The added benefit of APG-157 over bevacizumab alone is uncertain, and side effects are not yet well understood.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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: 1. creatinine \< 1.5 x institutional upper limit of normal (ULN). 2. total bilirubin \< 1.5 x ULN (unless due to Gilbert's disease) 3. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \<2.5 x ULN 4. serum alkaline phosphatase less than 2.5 times the upper limits of normal) 9. The patient must willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts. 10. Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment. 11. Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study. (Non-child bearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries). Exclusion Criteria: 1. 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 2. 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) 3. Lactating or pregnant 4. History of uncontrollable allergic reactions to bevacizumab 5. Clinically Significant Cardiovascular Disease Defined as follows: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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University of Nebraska Medical Center
RECRUITINGOmaha, Nebraska, 68198, United States
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