Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations
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Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
200estimated
Sites
25
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 | 2022-03-31 | actual | When the study began enrolling |
| Primary completion | 2025-11-03 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2022-02-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Non-Small Cell Lung Cancer
- Advanced Non-Small Cell Squamous Lung Cancer
- Metastatic Lung Non-Small Cell Carcinoma
- Metastatic Lung Cancer
- NSCLC
- Advanced Lung Carcinoma
- Epidermal Growth Factor Receptor C797S
- Epidermal Growth Factor Receptor G719X
- EGF-R Positive Non-Small Cell Lung Cancer
- EGFR-TKI Resistant Mutation
Intervention
- Drug: silevertinib (BDTX-1535) monotherapy
Primary outcomes
what the primary-completion date above is the date OFPhase 1 Dose Escalation: To determine the maximum tolerated dose (MTD), if one exists, and the preliminary recommended Phase 2 dose(s) (RP2D[s]) of silevertinib (BDTX-1535)
measured The first treatment 21-day cycle (Cycle 1)
Phase 2: To assess antitumor efficacy of silevertinib (BDTX-1535)
measured Day 1 every 2 cycles starting on Cycle 3 Day 1 to study completion, approximately 1 year (each cycle is 21 days)
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