Actively Recruiting
A Phase 0/2 Study of BGB-58067, an MTA Cooperative PRMT5 Inhibitor, in Newly Diagnosed Glioblastoma Patients With MTAP-Deleted Tumors Scheduled for Surgical Resection to Evaluate CNS Penetration and Pharmacodynamic Response
Led by Nader Sanai · Updated on 2026-05-14
78
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
Nader Sanai
Lead Sponsor
B
BeOne Medicines
Collaborating Sponsor
AI-Summary
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 0/2 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.
CONDITIONS
Brief Title
BGB-58067 in Newly Diagnosed Glioblastoma Patients With MTAP-Deleted Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected newly diagnosed glioblastoma according to 2021 WHO criteria without prior tumor treatment other than biopsy
- Measurable brain tumor with at least one contrast-enhancing lesion measuring 1 cm or more
- Age 18 years or older at time of consent
- Performance status of 2 or less on the ECOG scale
- Adequate bone marrow, liver, kidney, metabolic, and coagulation function as defined by specific laboratory values
- For females of childbearing potential: negative pregnancy test and use of highly effective contraception during and after the study
- Females of non-childbearing potential must have confirmed menopause
- For males: agreement to avoid sperm donation and use contraception or abstain from heterosexual intercourse during and after the study
- Willingness to follow lifestyle considerations and comply with study visits, treatments, and tests
- Able to understand and provide informed consent
You will not qualify if you...
- Unable to undergo brain MRI with intravenous contrast
- Active systemic bacterial, fungal, or detectable viral infection
- Significant cardiovascular conditions including low heart function, prolonged QTc interval, or recent heart events
- Presence of symptomatic or radiographic leptomeningeal disease
- Severe psychiatric or uncontrolled medical conditions that may pose safety risks
- Prior treatment with another investigational drug or PRMT5 inhibitor within a defined period
- Known allergies to components of BGB-58067
- Requirement for ongoing strong CYP3A or CYP2C8 inhibitors or inducers
- Receipt of live or attenuated vaccines within 30 days before treatment
- Pregnancy or breastfeeding
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Several days prior to surgery
Participants receive a high dose of BGB-58067 over several days prior to surgical tumor resection to evaluate drug penetration and pharmacodynamic effects.
1 to 2 visits including dosing and surgery
Duration - Until disease progression, unacceptable toxicity, or withdrawal
Participants demonstrating a positive pharmacodynamic response continue BGB-58067 treatment with standard radiotherapy. Participants with methylated MGMT tumors also receive temozolomide concurrently. After radiotherapy, participants receive adjuvant BGB-58067 monotherapy or combined with temozolomide depending on MGMT status, continuing until disease progression, unacceptable toxicity, or withdrawal.
Regular visits following a fixed cycle calendar during concurrent and adjuvant therapy
Duration - Approximately 30 days post last dose
Participants return to the clinic for safety monitoring after discontinuing BGB-58067 treatment.
1 to 2 visits
Duration - Up to 24 months
Participants are contacted approximately every 3 months for up to 24 months to collect survival data following the safety follow-up.
Quarterly contact every 3 months
Trial Site Locations
Total: 1 location
1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Actively Recruiting
Research Team
P
Phase 0 Navigator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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