Status:
RECRUITING
Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab
Lead Sponsor:
Aveta Biomics, Inc.
Conditions:
Glioma
Glioblastoma Multiforme
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
Brief 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 a...
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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).
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06011109
Start Date
December 13 2023
End Date
January 31 2026
Last Update
October 2 2025
Active Locations (2)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198