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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Nader Sanai
Study ID
NCT07485049
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Glioblastoma (GBM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BGB-58067 — DRUG
    During Phase 0, a high dose of BGB-58067 will be administered over several days prior to surgery to determine PK and PD effect in resected tumor tissue. During Phase 2, BGB-58067 dosing will continue with standard radiation therapy (RT) followed with adjuvant therapy. Participants will receive monotherapy or concurrent therapy with temozolomide (TMZ) based on MGMT methylation status.

Study Details

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.

Key Dates

Start date
May 7, 2026
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2028

Study Design

Enrollment
78 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Unmethylated-MGMT GBM-BGB-58067 Monotherapy
    Participants with unmethylated-MGMT and MTAP-deleted GBM demonstrating a positive PD response after Phase 0 surgery.
  • Experimental: Arm B: Methylated-MGMT GBM-BGB-58067 + TMZ Concurrent Therapy
    Participants with methylated-MGMT and MTAP-deleted GBM demonstrating a positive PD response after Phase 0 surgery.

Primary Outcome Measure

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 [ Time Frame: Intraoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Joseph's Hospital and Medical CenterPhoenixArizona85013
Phase 0 Navigator
[email protected]
602-406-8605
Nader Sanai, MD (PRINCIPAL_INVESTIGATOR)
Yoshie Umemura, MD (SUB_INVESTIGATOR)
Kelly Braun, MD (SUB_INVESTIGATOR)
Igor Barani, MD (SUB_INVESTIGATOR)
William Kennedy, MD (SUB_INVESTIGATOR)
Sirin Gandhi, MD (SUB_INVESTIGATOR)
Eva Duran, DNP (SUB_INVESTIGATOR)

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By research site
St. Joseph's Hospital and Medical Center· Phoenix, AZ

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