JZP3507 for Meningioma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medicine, JZP3507, for individuals with Grade 2 or 3 meningiomas, a type of brain tumor. The goal is to determine if JZP3507 can shrink these tumors and ensure its safety. Those whose tumors have not responded to other treatments may be suitable candidates, particularly if their tumor is growing or they have developed a new tumor. Participants must be able to swallow pills and have had recent brain scans to join the trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant medical advancements.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking certain medications, such as strong CYP3A4 inhibitors and inducers, at least 14 days before starting the study. If you're on any anticancer therapy or investigational agents, you need to stop them 28 days before the trial, or 42 days if it's antibody-based therapy.
Is there any evidence suggesting that JZP3507 is likely to be safe for humans?
Research has shown that JZP3507, also known as ONC206, is under study for its safety in treating certain brain tumors called meningiomas. Early results suggest that ONC206 is generally well-tolerated. In one study, patients with meningiomas that had spread outside the brain showed promising results, with some patients maintaining stable disease for six months or more.
Early evidence also indicates that ONC206 can be used safely with other treatments, like CAR T cells, without interfering with their function. This suggests it might be safe to use in combination with other therapies.
Since the current study is in Phase 2, the treatment has already passed basic safety tests in earlier trials. This means it is considered safe enough for more people to try, but researchers continue to closely monitor its effects on humans.12345Why do researchers think this study treatment might be promising for meningioma?
Unlike the standard treatments for meningioma, which typically involve surgery and radiation, JZP3507 (ONC206) is unique because it targets the tumor's cellular machinery in a novel way. This treatment works by inhibiting a specific pathway that is crucial for the survival and growth of tumor cells, potentially offering a more direct and effective approach. Researchers are excited about JZP3507 because it promises a new mechanism of action that could enhance treatment outcomes and offer hope to patients who may not respond well to current options.
What evidence suggests that JZP3507 might be an effective treatment for meningioma?
Research has shown that JZP3507, also known as ONC206, may help treat meningioma, a type of brain tumor. Studies have found that JZP3507 alters the mitochondria, the energy centers of cells. This alteration can slow tumor growth and improve survival rates. In tests with mice, JZP3507 significantly increased survival, demonstrating strong anti-cancer effects. These results suggest that JZP3507 could effectively treat meningioma in humans. Participants in this trial will receive JZP3507 to further evaluate its effectiveness in treating meningioma.14678
Are You a Good Fit for This Trial?
This trial is for adults (18+) with Grade 2 or 3 meningioma that has come back or gotten worse after standard treatments, and who have at least one tumor visible on MRI. Participants must be able to swallow pills, have a good performance status, and meet certain lab test requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral doses of JZP3507 to evaluate antitumor activity and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- JZP3507
Trial Overview
The study tests an oral drug called JZP3507 in people with recurrent Grade 2 or 3 meningioma. All participants receive the drug to see how well it works against their tumors and to monitor its safety.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jazz Pharmaceuticals
Lead Sponsor
Bruce C. Cozadd
Jazz Pharmaceuticals
Chief Executive Officer since 2009
BA in Economics from Yale University, MBA from Stanford University
Dr. Austin
Jazz Pharmaceuticals
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland
Chimerix, Inc.
Industry Sponsor
Citations
A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 ...
This study will recruit participants with Grade 2 and 3 meningiomas who have failed prior therapy. Participants will receive oral doses of ...
2.
investor.jazzpharma.com
investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-showcases-new-clinical-and-translational/Jazz Pharmaceuticals Showcases New Clinical and ...
Data highlight continued progress in Jazz's brain tumor research and demonstrate the company's commitment to advancing treatment options for ...
Meningioma: Novel Diagnostic and Therapeutic Approaches
This manuscript aims to provide a comprehensive review of novel diagnostic and therapeutic approaches against these tumors.
Allosteric ClpP agonist ONC206 alters mitochondrial ...
Our results indicate that ClpP agonism is directly involved in mediating the anticancer effects of potent novel agent ONC206 in meningioma.
TMET-26. Allosteric ClpP agonist ONC206 alters ...
Our results indicate that ClpP agonism is directly involved in mediating the anti-cancer effects of potent novel agent ONC206 in meningioma.
A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 ...
This study will recruit participants with Grade 2 and 3 meningiomas who have failed prior therapy. Participants will receive oral doses of JZP3507. The ...
Clinical Significance of Molecular Alterations and Systemic ...
Notably, the trial enrolled seven patients with metastatic extracranial meningiomas, of whom four achieved 6-month PFS and one patient had PFS lasting for ...
8.
academic.oup.com
academic.oup.com/neuro-oncology/advance-article/doi/10.1093/neuonc/noag025/8460778Preclinical efficacy of combinatorial B7-H3 CAR T cells and ...
Our data demonstrates that ONC206 can be combined with B7-H3 CAR T cells without compromising T cell metabolic fitness, phenotype, or ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.