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NCT07485049 · ClinicalTrials.gov registry record · Early Phase 1
BGB-58067 in Newly Diagnosed Glioblastoma Patients With MTAP-Deleted Tumors
A Early Phase 1 study, sponsored by Nader Sanai.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 78
- Enrollment target
NCT07485049 is a Early Phase 1 study that is actively recruiting participants, run by Nader Sanai. The registered enrollment target is 78 participants.
The verdict
NCT07485049, a Early Phase 1 study, is actively recruiting participants, sponsored by Nader Sanai.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 78 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG BGB-58067
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2026-05-07 |
| Est. Completion | 2028-11 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07485049
The ClinicalTrials.gov registry entry for NCT07485049 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nader Sanai, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BGB-58067 is the first listed.
NCT07485049 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07485049 about?
NCT07485049 is a clinical study titled "BGB-58067 in Newly Diagnosed Glioblastoma Patients With MTAP-Deleted Tumors". 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 pharma...
What is the current status of trial NCT07485049?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 78 participants. The study started on 2026-05-07. Estimated completion is 2028-11.
What interventions are being tested in trial NCT07485049?
The interventions under investigation include: BGB-58067 (DRUG).
Who is sponsoring clinical trial NCT07485049?
This trial is sponsored by Nader Sanai, which has 13 total clinical trials registered on ClinicalTrials.gov.
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