BGB-58067 in Newly Diagnosed Glioblastoma Patients With MTAP-Deleted Tumors
ConditionGlioblastoma (GBM)
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNader Sanai
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
LVEF < 50%
History of prolonged QTc, or QT interval corrected for heart rate using Fridericia's formula (QTcF) prolongation > 480 msec, except for right bundle branch block.
Trial design
Treatments tested in this trial
- BGB-58067
Treatment groups
78 Participants
are divided into 2 treatment groupsSponsors and collaborators
Nader Sanai
Lead sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Sponsor institution
BeOne Medicines
Collaborator
Source ClinicalTrials.gov