BGB-58067 for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This is an open-label, multi-center, Phase 0/2 trial designed to enroll up to 78 total participants with suspected newly diagnosed glioblastoma (nGBM) who are scheduled for surgical resection to accrue at least 14 participants in Arm A and 10 participants in Arm B. The trial will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of BGB-58067.
The study is composed of a Phase 0 and expansion Phase 2 component. The Phase 0 primary endpoint will be suppression of symmetric dimethylarginine (SDMA) in tumor tissue measured by immunohistochemistry (IHC). The Phase 2 primary endpoint will be 12-month overall survival rate (OS12).
The Phase 0 secondary endpoint will be to characterize the PK of BGB-58067 in tumor tissue, plasma, and cerebrospinal fluid (CSF). The Phase 2 secondary endpoints will include assessing the safety profile of BGB-58067 and evaluating clinical efficacy of BGB 58067 using overall survival (OS) and the 6-month progression-free survival rate (PFS6) estimated by Kaplan-Meier (K-M) methods.
Who Is on the Research Team?
Nader Sanai, MD
Principal Investigator
Ivy Brain Tumor Center
Are You a Good Fit for This Trial?
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
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
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