A Pilot Study of APG-157 With Bevacizumab for Patients With Recurrent High-Grade Glioma

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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).

Locations
United States
Minnesota
Mayo Clinic
RECRUITING
Rochester
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
Contact Information
Primary
Nicole Shonka, MD
nshonka@unmc.edu
402-559-3881
Backup
Apar Ganti, MD
aganti@unmc.edu
Time Frame
Start Date: 2023-12-13
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 30
Treatments
Experimental: APG-157
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.
Sponsors
Leads: Aveta Biomics, Inc.

This content was sourced from clinicaltrials.gov

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