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BGB-58067 for Newly Diagnosed Glioblastoma with MTAP-Deleted Tumors

This study is testing a drug called BGB-58067 for people newly diagnosed with glioblastoma (GBM), a type of brain cancer, whose tumors have a specific genetic change called MTAP-deletion. In the first part of the study (Phase 0), you would receive a high dose of BGB-58067 before surgery to see how the drug affects your tumor. If your tumor responds well, you may be able to continue with BGB-58067 along with standard radiation therapy in the second part of the study (Phase 2). Researchers will be looking to see if the drug reduces a marker called SDMA in your tumor and if it helps people live longer. You can join if you are 18 or older, have newly diagnosed glioblastoma, and have a measurable tumor.

Study design
This is an open-label, multi-center study with two parts (Phase 0 and Phase 2) planning to enroll up to 78 participants. It is not randomized, meaning there is no comparison group receiving a placebo.
What's involved
In Phase 0, you would receive BGB-58067 for several days before surgery. If you continue to Phase 2, you would receive BGB-58067 with radiation therapy and then as ongoing adjuvant therapy.
Compensation
Not stated in the trial record.
Follow-up
Participants in Phase 2 will be followed for up to 12 months to assess overall survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07485049

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Nader Sanai
~78 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:BGB-58067

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 0: Proportion of Participants with ≥ 50% Decrease from Baseline in SDMA Expression, or with SDMA H-Score ≤ 70, in Phase 0 Tumor Tissue Collected Intraoperatively
Measured over Intraoperatively
+1 more outcome measured

Conditions

Glioblastoma (GBM)

Explore related trials

GlioblastomaMTAP Gene

Where it's being run

1 sites across 1 states
Arizona1

Study leadership

  • Nader Sanai, MD · PRINCIPAL_INVESTIGATOR · Ivy Brain Tumor Center

Who to contact

Phase 0 Navigator
[email protected]
602-406-8605
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

1\. Suspected newly diagnosed glioblastoma according to 2021 WHO criteria who have not received any tumor directed intervention other than biopsy.
2\. Has measurable disease (preoperatively), defined as at least one contrast-enhancing lesion with two perpendicular measurements of at least 1 cm.
3\. Age ≥ 18 at time of consent.
4\. Has a performance status of ≤ 2 on the ECOG scale.
5\. Has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility):
6\. For females of childbearing potential:
7\. For females of non-childbearing potential, is no longer of childbearing potential due to surgical, chemical, or natural menopause.
8\. For males:
9\. Agrees to adhere to protocol defined Lifestyle Considerations throughout study duration.
10\. Able and willing to comply with scheduled visits, treatment plans, laboratory tests and other procedures.
11\. Understands the informed consent document and has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable). Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.

Exclusion

1\. Unable to undergo MRI of the brain with intravenous (IV) contrast.
2\. Has a known active systemic bacterial infection (on IV antibiotics or has fever \> 38.5°C at time of initiating study treatment) or fungal infection, or has a detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[e.g., hepatitis B surface antigen positive\]). NOTE: Screening of viral infection is not required for enrollment.
3\. Has cardiovascular abnormalities including:
4\. Has symptomatic or radiographic leptomeningeal disease.
5\. Has other known concurrent severe psychiatric and/or uncontrolled medical condition that, in the investigator's judgment, would cause unacceptable safety risks, contraindicate participation in the clinical study, or compromise compliance with the protocol.
6\. Has received prior treatment with another investigational drug or other intervention within 5 half lives of the investigational product, whichever is longer.
7\. Has received prior treatment with another PRMT5 inhibitor.
8\. Has known allergic reactions to components of BGB-58067.
9\. Patients who require ongoing treatment with a strong CYP3A or CYP2C8 inhibitor or inducer, ≤ 5 half-lives or ≤ 14 days, whichever is shorter or known. Consider using alternative medications, per Investigator judgment.
10\. Has received a live/attenuated vaccine within 30 days of anticipated first treatment. The use of inactivated seasonal influenza vaccines (e.g., Fluzone®) will be permitted.
11\. Is pregnant or breastfeeding.

What this trial measures

  • Phase 0: Proportion of Participants with ≥ 50% Decrease from Baseline in SDMA Expression, or with SDMA H-Score ≤ 70, in Phase 0 Tumor Tissue Collected IntraoperativelyIntraoperatively

    Decrease in SDMA expression in tumor tissue collected during Phase 0 surgery relative to baseline will be used if pre-treatment biopsy tissue is available. Otherwise, H-score ≤ 70 in tumor tissue collected during Phase 0 surgery will be used.

  • Phase 2: Proportion of Participants Alive at 12 MonthsDate of Phase 0 surgery to date of death due to any cause, assessed up to 12 months

    Overall survival at 12 months (OS12)