GliomaPhase 1/2NCT06011109
Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab
A Phase 1/2 study testing APG-157 in people with Glioma and Glioblastoma Multiforme, run by Aveta Biomics, Inc. at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Glioma, Glioblastoma Multiforme
- What is being tested?
- APG-157
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Dec 2023to 30 Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
- Patients must have recovered from any toxicity of prior therapy to Grade 1 or less.
- ECOG Performance Status of 0-3.
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- Patients must have an adequate bone marrow reserve (ANC count ≥1,500/mm3, hemoglobin > 8 g/dL, platelet count ≥100,000/mm3).
- Patients must have adequate renal and hepatic function with:
- creatinine < 1.5 x institutional upper limit of normal (ULN).
- total bilirubin < 1.5 x ULN (unless due to Gilbert's disease)
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 x ULN
- serum alkaline phosphatase less than 2.5 times the upper limits of normal)
- 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.
- 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.
- 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).
Who cannot join
- 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
- 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)
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- History of cerebrovascular accident (CVA) within 6 months
- Myocardial infarction or unstable angina within 6 months
- 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
- Active wound, a serious or non-healing wound, an active ulcer or untreated bone fracture within the last two months.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess ≤ 6 months prior to registration.
- Major surgical procedure, open biopsy, or significant traumatic injury ≤ 28 days prior to registration
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Pilot Study of APG-157 With Bevacizumab for Patients With Recurrent High-Grade Glioma
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.
Read the detailed 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 who have previously progressed on bevacizumab alone. 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
Additional aims include:
- characterization of pharmacokinetics (PK) of APG-157 in the presence of bevacizumab; and
- optionally serum changes in VEGF and HIF-1 alpha, if the study shows preliminary indication of efficacy
The participants will take APG-157 daily by dissolving two pastilles in their mouth at around breakfast, lunch and dinner time (total of 6 pastilles per day). The pastilles dissolve in the mouth.
The participants will continue to receive Bevacizumab and be present for scheduled visits and examinations as standard of care.
- Conditions
- Glioma, Glioblastoma Multiforme
- Being tested
- APG-157
- Keywords
- APG-157, Bevacizumab
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APG-157Drug
The participants will receive APG-157 daily; and continue to receive Bevacizumab as standard of care.
| Study group | Role | What they receive |
|---|---|---|
| APG-157 | Experimental | The 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. Receives: Drug: APG-157 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
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.
Measured: 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
Overall Survival
To evaluate overall survival of participants with recurrent high-grade glioma treated with APG-157 and Bevacizumab
Measured: 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.
Secondary outcomes (3)
QOL assessment (EORTC QLQ-C30)
Descriptively examine quality of life (QOL) using EORTC QLQ-C30 (Organization for Research and Treatment in Cancer Quality of Life Questionnaire C30). EORTC QLQ-C30 is a standardized questionnaire that rates function, symptoms and health status from patient perspective using various questions on a scale of 1 - 4 where generally 1 is rated as normal or no issue (not at all) and 4 being the maximum adverse impact being experienced (very much).
Measured: Every 8 weeks; 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
Radiographic studies MRI or CT of the brain
To measure tumor size in response to treatment
Measured: Every 8 weeks; from date of commencement of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Pharmacokinetics (PK) of APG-157
Measure the amount of APG-157 components in the blood in the presence of bevacizumab
Measured: At three timepoints: at start of dosing; at end of cycle 1 (each cycle is 28 days); and at end of cycle 2 after start of dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start13 Dec 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aveta Biomics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole Shonka, MD, Principal investigator, University of NebraskaJoon Uhm, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011109
- Sponsor's protocol ID
- AVTA 22-01
- Status last verified
- Sep 2026
- First submitted
- 9 Aug 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of APG-157 With Bevacizumab for Patients With Recurrent High-Grade Glioma
- ClinicalTrials.gov ID
- NCT06011109
- Acronym / sponsor ID
- AVTA 22-01
- Conditions
- Glioma, Glioblastoma Multiforme
- Keywords
- APG-157, Bevacizumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aveta Biomics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 who have previously progressed on bevacizumab alone. 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
Additional aims include:
- characterization of pharmacokinetics (PK) of APG-157 in the presence of bevacizumab; and
- optionally serum changes in VEGF and HIF-1 alpha, if the study shows preliminary indication of efficacy
The participants will take APG-157 daily by dissolving two pastilles in their mouth at around breakfast, lunch and dinner time (total of 6 pastilles per day). The pastilles dissolve in the mouth.
The participants will continue to receive Bevacizumab and be present for scheduled visits and examinations as standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APG-157 | Experimental | Drug: 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.)
- Patients must have recovered from any toxicity of prior therapy to Grade 1 or less.
Key exclusion criteria (13 listed)
- 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
- Clinically Significant Cardiovascular Disease Defined as follows:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APG-157The participants will receive APG-157 daily; and continue to receive Bevacizumab as standard of care. | Drug | APG-157 |
Primary outcome
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
3 secondary outcomes
QOL assessment (EORTC QLQ-C30)
Time frame: Every 8 weeks; 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
Radiographic studies MRI or CT of the brain
Time frame: Every 8 weeks; from date of commencement of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Pharmacokinetics (PK) of APG-157
Time frame: At three timepoints: at start of dosing; at end of cycle 1 (each cycle is 28 days); and at end of cycle 2 after start of dosing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Shonka, MD principal investigator
University of Nebraska
Joon Uhm, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing APG-157 in people with Glioma and Glioblastoma Multiforme, run by Aveta Biomics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.