Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations (NCT05256290)
A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients With Glioblastoma or Non-Small Cell Lung Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (25 Sites)
- University of Alabama — Birmingham, Alabama
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- City of Hope Huntington Beach — Huntington Beach, California
- City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California
- Cedars Sinai Medical Center — Los Angeles, California
- Sibley Memorial Hospital Johns Hopkins Medicine — Washington D.C., District of Columbia
- Mayo Clinic- Jacksonville — Jacksonville, Florida
- Miami Cancer Institute - Baptist Health South Florida — Miami, Florida
- UHP- University of Hawaii Cancer Center — Honolulu, Hawaii
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University — Chicago, Illinois
- University of Kansas Cancer Center — Fairway, Kansas
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Mayo Clinic- Rochester — Rochester, Minnesota
- Siteman Cancer Center — St Louis, Missouri
- Memorial Sloan Kettering Cancer Center — New York, New York
- Columbia University Irving Medical Center — New York, New York
- Montefiore Medical Center — The Bronx, New York
- UNC Hospitals - Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina
- University of Pittsburgh Medical Center - Hillman Cancer Center — Pittsburgh, Pennsylvania
- Tennessee Oncology — Nashville, Tennessee
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- Inova Schar Cancer Institute — Fairfax, Virginia
- Next Ocology — Fairfax, Virginia
- Fred Hutchinson Cancer Center/University of Washington — Seattle, Washington
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Osimertinib and Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer — Boston, Massachusetts
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Explore by condition: All Non-Small Cell Lung Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.