Phase 02 Study of BGB-58067 Drug in Adults with Newly Diagnosed Glioblastoma Having MTAP-Deleted Tumors Scheduled for Surgery to Study Drug Effects and Safety

What this Trial Is About

Researchers are evaluating BGB-58067, a drug being studied in people with suspected newly diagnosed glioblastoma nGBM, a type of brain tumor. This open-label, multi-center Phase 02 trial aims to assess how BGB-58067 behaves in the body pharmacokinetics and pharmacodynamics, its safety, and its effect on tumor tissue. The study includes patients scheduled for surgical tumor removal and focuses on tumors with a methylthioadenosine phosphorylase MTAP deletion. The primary goals are to reduce a tumor marker called symmetric dimethylarginine SDMA in Phase 0 and to measure the 12-month survival rate in Phase 2. In Phase 0, participants receive a high dose of BGB-58067 before surgery to study drug penetration and effects on the tumor. After surgery, those with a positive drug response are assigned to Phase 2, divided into two groups based on a tumor marker called MGMT methylation status. Arm A includes patients with unmethylated tumors receiving BGB-58067 alongside standard radiation therapy, followed by continuous BGB-58067 monotherapy. Arm B includes patients with methylated tumors who receive BGB-58067 with radiation and temozolomide chemotherapy, continuing BGB-58067 through and after chemotherapy. Treatment continues until disease progression or other reasons for stopping. Participants undergo regular assessments including MRI scans every 2 to 3 months to monitor tumor progression. Safety follow-up visits occur after treatment ends, with survival data collected approximately every 3 months for up to 24 months. Researchers may also analyze tumor and cerebrospinal fluid samples collected during surgery and follow-up to study genetic changes and understand resistance to treatment. The study includes detailed safety assessments and monitoring to track outcomes such as survival and progression-free survival.

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