Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
← catalyst calendarNCT07326566 · readout ≤ 834 d
Sponsored by Black Diamond Therapeutics, Inc. (industry) · BDTX — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
162estimated
Sites
24
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-05-05 | actual | When the study began enrolling |
| Primary completion | Nov 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2026-01-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Glioblastoma (GBM)
- Newly Diagnosed Glioblastoma
- GBM
- Glioblastoma Multiforme (GBM)
- Glioma
- Central Nervous System Diseases
- Brain Cancer
Interventions
- Drug: silevertinib in combination with temozolomide — also filed as BDTX-1535, Temodar, TMZ
- Drug: temozolomide (TMZ) — also filed as TMZ, Temodar
Primary outcome
what the primary-completion date above is the date OFProgression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)
measured 12 months
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