Actively Recruiting
BGB-58067 in Newly Diagnosed Glioblastoma Patients With MTAP-Deleted Tumors
Led by Nader Sanai · Updated on 2026-05-14
78
Participants Needed
1
Research Sites
129 weeks
Total Duration
On this page
Sponsors
N
Nader Sanai
Lead Sponsor
B
BeOne Medicines
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 with no prior tumor treatment except biopsy
- Measurable disease before surgery with at least one contrast-enhancing lesion measuring 1 cm or larger
- Age 18 years or older at time of consent
- Performance status of 2 or less on the ECOG scale
- Adequate bone marrow function: neutrophils 1500/bcL, platelets 100,000/bcL, hemoglobin 9.0 g/dL without recent transfusion or erythropoietin
- Adequate liver function: bilirubin 1.5x upper limit of normal (ULN), AST and ALT 2.5x ULN (with some exceptions for liver metastases)
- Adequate kidney function: eGFR 160 mL/min/1.73 m2
- Adequate metabolic function: albumin 2.8 g/dL
- Adequate coagulation: INR, PT, and aPTT 1.5x ULN
- For females of childbearing potential: negative pregnancy test before treatment start, use of effective contraception during and for 6 months after treatment, no breastfeeding, and no egg donation during and 6 months after treatment
- For females not of childbearing potential: confirmation of menopause or equivalent
- For males: agreement to avoid sperm donation and either remain abstinent or use condoms with partner's contraception during and for 3 months after treatment
- Agreement to follow lifestyle considerations during the study
- Ability and willingness to comply with study visits, treatments, lab tests, and procedures
- Understanding and voluntary signing of informed consent before any screening procedures
You will not qualify if you...
- Unable to have brain MRI with intravenous contrast
- Active systemic bacterial, fungal, or detectable viral infection (e.g., HIV or active hepatitis B or C)
- Cardiovascular issues including left ventricular ejection fraction under 50%, prolonged QTc interval over 480 msec (except right bundle branch block), or significant uncontrolled heart conditions within 6 months
- Symptomatic or imaging evidence of leptomeningeal disease
- Severe psychiatric or uncontrolled medical conditions posing safety risks or compliance issues
- Prior treatment with investigational drugs within 5 half-lives of study drug or previous PRMT5 inhibitor use
- Known allergies to BGB-58067 components
- Need for ongoing treatment with strong CYP3A or CYP2C8 inhibitors or inducers near study start
- Receipt of live or attenuated vaccine within 30 days before first treatment (inactivated flu vaccine allowed)
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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