BGB-58067 in Newly Diagnosed Glioblastoma Patients With MTAP-Deleted Tumors

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.

NCT Number	NCT07485049
Lead Sponsor	Nader Sanai Collaborators: BeOne Medicines
Conditions	Glioblastoma (GBM)
Enrollment	78 participants
Start Date	2026-05-07
Primary Completion	2027-11 (estimated)
Study Completion	2028-11 (estimated)
Updated on ClinicalTrials.gov	2026-05-14