Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations
Public ClinicalTrials.gov record NCT05256290. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients With Glioblastoma or Non-Small Cell Lung Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of silevertinib (BDTX-1535). The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma (GBM) expressing EGFR alterations (Phase 1 only). All patients will self-administer silevertinib (BDTX-1535) monotherapy by mouth in 21-day cycles. Phase 1 enrollment is now complete. Phase 2 is currently ongoing.
Study identification
- NCT ID
- NCT05256290
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 200 participants
Conditions and interventions
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
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2022 (Actual)
- Primary completion
- Nov 3, 2025 (Actual)
- Completion
- Dec 2027 (Estimated)
- Last update posted
- Jul 22, 2026
2022 – 2027
United States locations
- U.S. sites
- 25
- U.S. states
- 19
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | — |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| City of Hope Huntington Beach | Huntington Beach | California | 92648 | — |
| City of Hope Orange County Lennar Foundation Cancer Center | Irvine | California | 92618 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| Sibley Memorial Hospital Johns Hopkins Medicine | Washington D.C. | District of Columbia | 20016 | — |
| Mayo Clinic- Jacksonville | Jacksonville | Florida | 32224 | — |
| Miami Cancer Institute - Baptist Health South Florida | Miami | Florida | 33176 | — |
| UHP- University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | — |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611 | — |
| University of Kansas Cancer Center | Fairway | Kansas | 66205 | — |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Mayo Clinic- Rochester | Rochester | Minnesota | 55905 | — |
| Siteman Cancer Center | St Louis | Missouri | 63110 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | — |
| Columbia University Irving Medical Center | New York | New York | 10032 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| UNC Hospitals - Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27514 | — |
| University of Pittsburgh Medical Center - Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | — |
| Next Ocology | Fairfax | Virginia | 22031 | — |
| Fred Hutchinson Cancer Center/University of Washington | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05256290, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 22, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05256290 live on ClinicalTrials.gov.