Study on Treating Recurrent High-Grade Glioma with APG-157 and Bevacizumab
Sponsor: Aveta Biomics, Inc.
ClinicalTrials ID:NCT06011109
This clinical trial is testing a new treatment combination of APG-157 and Bevacizumab for patients with recurrent high-grade glioma, a type of brain cancer. The study aims to see if this combination can improve survival, quality of life, and tumor response.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to evaluate the effectiveness of a new treatment combination using APG-157 and Bevacizumab for patients with recurrent high-grade glioma, a type of aggressive brain cancer. The study will look at how well patients do in terms of survival without the cancer getting worse, overall survival, quality of life, and how the tumors respond to the treatment on scans. Participants will take APG-157 by dissolving two pastilles in their mouth three times a day, around meal times, while continuing their standard Bevacizumab treatment.
Description
This study is testing a new treatment approach for patients with recurrent high-grade glioma, a type of brain cancer that has come back after previous treatment. The study combines APG-157, a new drug, with Bevacizumab, a standard treatment. The main goals are to see if this combination can help patients live longer without the cancer getting worse, improve their overall survival, and enhance their quality of life. Researchers will also look at how the tumors respond to the treatment on imaging scans.
Participants will take APG-157 by dissolving two pastilles in their mouth three times a day, around breakfast, lunch, and dinner. They will continue to receive Bevacizumab as part of their standard care. The study will also explore how the body processes APG-157 when used with Bevacizumab and may look at changes in certain blood markers if the treatment shows promise.
Participants will need to attend regular visits and examinations as part of their standard care while participating in the study.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of high-grade glioma (grade III or IV) that has returned after treatment with Bevacizumab.
- Have previously received radiation therapy and standard chemotherapy with temozolomide.
- Be at least three months past the end of chemoradiotherapy or have evidence of disease progression.
- Be 19 years or older.
- Have recovered from any side effects of previous treatments to a mild level.
- Have an ECOG performance status of 0 to 3, indicating varying levels of activity.
- Have adequate blood cell counts and organ function, including:
- Neutrophil count of at least 1,500/mm3.
- Hemoglobin level above 8 g/dL.
- Platelet count of at least 100,000/mm3.
- Normal kidney and liver function as indicated by specific blood tests.
- Be willing to provide informed consent and understand the study procedures and potential risks.
- Women of childbearing potential must not be pregnant or nursing and must agree to use effective birth control during the study and for six months after treatment.
- Women must have a negative pregnancy test before starting the study.
Exclusion Criteria
- Have any life-threatening illness or medical condition that could affect safety or the study's outcomes.
- Have received immunotherapy, chemotherapy, radiotherapy, or experimental therapy within a specific period before starting the study.
- Be pregnant or breastfeeding.
- Have a history of severe allergic reactions to Bevacizumab.
- Have significant heart or blood pressure problems, such as uncontrolled high blood pressure or recent heart attack.
- Have a history of bleeding disorders or recent significant bleeding events.
- Have active or serious wounds, ulcers, or untreated bone fractures.
- Have had major surgery or significant injury within the last 28 days.
- Have any other medical or psychiatric condition that could interfere with the study or informed consent.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.