RecruitingPhase 1Phase 2NCT06011109

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

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


Sponsor

Aveta Biomics, Inc.

Enrollment

30 participants

Start Date

Dec 13, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of APG-157 (an experimental oral drug derived from curcumin) and bevacizumab (a drug that blocks tumor blood vessel growth) for patients with high-grade brain tumors (glioma, grade III or IV) that have come back after prior treatment. **You may be eligible if...** - You are 19 or older (age of consent in Nebraska) - You have been diagnosed with a high-grade glioma (grade III or IV, including glioblastoma) that has progressed on bevacizumab - You have previously received radiation therapy and standard temozolomide chemotherapy - You are in reasonable health (ECOG 0–3) - Your blood counts, kidney function, and liver function are within acceptable levels **You may NOT be eligible if...** - Your cancer is not a high-grade glioma or has not previously progressed on bevacizumab - You have not recovered from side effects of your last treatment - You are pregnant or breastfeeding - You have severe organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAPG-157

The participants will receive APG-157 daily; and continue to receive Bevacizumab as standard of care.


Locations(2)

Mayo Clinic

Rochester, Minnesota, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

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NCT06011109


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