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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: Recruiting Early Phase 1 study, sponsored by Nader Sanai.
NCT07485049 is a Early Phase 1 study that is actively recruiting participants, run by Nader Sanai. The registered enrollment target is 78 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What NCT07485049 shows while recruiting
NCT07485049 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 1 intervention - of which BGB-58067 is the first listed.
NCT07485049 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07485049's enrollment target sits among peer trials
78 300th of 2000 higher than 1,700 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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