BGB-58067 for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment called BGB-58067 for individuals with suspected newly diagnosed glioblastoma, a type of brain cancer. Researchers will examine the drug's behavior in the body and assess its overall safety. Participants will be divided into two groups: one will receive BGB-58067 alone, while the other will receive it alongside another medication. Ideal participants have not yet undergone treatment for glioblastoma and have a measurable tumor. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it mentions that patients who require ongoing treatment with certain strong medications may need to consider alternatives. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that BGB-58067 has been studied to assess its safety and tolerability. Previous studies found that most patients tolerated BGB-58067 well, and researchers examined the body's reaction to the drug and its effects. These studies have not widely reported any serious side effects. However, since this trial is in an early stage, it primarily aims to gather more detailed safety information.
Direct safety information for the combination of BGB-58067 with temozolomide (TMZ) is limited. TMZ, a well-known drug for treating glioblastoma, is considered safe. The safety of combining BGB-58067 with TMZ remains under investigation.
Overall, current evidence suggests that BGB-58067 is likely safe, but further research will provide a clearer understanding. Researchers will closely monitor trial participants to ensure their safety as more information is collected.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for glioblastoma, which typically include surgery, radiation, and chemotherapy with temozolomide, BGB-58067 is paving a new path. This investigational drug is unique because it targets specific genetic markers in glioblastoma, such as unmethylated-MGMT and MTAP-deleted genes. In Arm A, BGB-58067 is used as a monotherapy for tumors with unmethylated-MGMT, while Arm B combines it with temozolomide for methylated-MGMT tumors. Researchers are excited about the potential of BGB-58067 to offer a more personalized and potentially more effective treatment for glioblastoma patients by directly targeting these genetic alterations.
What evidence suggests that BGB-58067 might be an effective treatment for glioblastoma?
Research has shown that BGB-58067 may help treat glioblastoma by blocking PRMT5, a protein linked to worse outcomes in some cancers. Early studies demonstrated its ability to slow tumor growth. In this trial, participants in Arm A will receive BGB-58067 as monotherapy. Meanwhile, Arm B will study BGB-58067 combined with temozolomide (TMZ), a drug known to improve survival rates in glioblastoma patients. Researchers are carefully studying both treatments to ensure safety and effectiveness.16789
Who Is on the Research Team?
Nader Sanai, MD
Principal Investigator
Ivy Brain Tumor Center
Are You a Good Fit for This Trial?
This trial is for adults (18+) with newly diagnosed glioblastoma that has not been treated except possibly by biopsy. Participants must have a measurable tumor, good organ function, and be healthy enough for surgery. Women of childbearing age need a negative pregnancy test.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 0
Participants receive a high dose of BGB-58067 prior to surgical resection to evaluate CNS penetration and PD effects.
Phase 2
Participants with a positive PD response continue BGB-58067 treatment with standard of care radiotherapy and/or temozolomide.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with survival data collection every 3 months.
What Are the Treatments Tested in This Trial?
Interventions
- BGB-58067
Trial Overview
The study tests BGB-58067 in people with MTAP-deleted glioblastoma. It looks at how the drug behaves in the body, its effects on tumors, safety, and survival rates over time. The trial includes both an early phase to check drug activity and a later phase to assess benefits.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants with methylated-MGMT and MTAP-deleted GBM demonstrating a positive PD response after Phase 0 surgery.
Participants with unmethylated-MGMT and MTAP-deleted GBM demonstrating a positive PD response after Phase 0 surgery.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nader Sanai
Lead Sponsor
BeOne Medicines
Industry Sponsor
Citations
Phase 0/2 PD-Trigger Study of BGB-58067 in Newly ...
ARM B Participants with methylated-MGMT and MTAP-deleted GBM demonstrating a positive PD response will continue BGB-58067 treatment concurrently ...
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BGB-58067 for Glioblastoma · Info for Participants
Participants are monitored for safety and effectiveness after treatment, with survival data collection every 3 months. 24 months. Follow-up ...
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