Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations
Running, not enrolling · Phase 1/Phase 2
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT05256290
- Run by
- Black Diamond Therapeutics, Inc.
- People needed
- 200
- Starts
- 2022-03-31
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama — Birmingham, Alabama, United States
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
- City of Hope Huntington Beach — Huntington Beach, California, United States
- City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States
- Cedars Sinai Medical Center — Los Angeles, California, United States
- Sibley Memorial Hospital Johns Hopkins Medicine — Washington D.C., District of Columbia, United States
- Mayo Clinic- Jacksonville — Jacksonville, Florida, United States
- Miami Cancer Institute - Baptist Health South Florida — Miami, Florida, United States
- UHP- University of Hawaii Cancer Center — Honolulu, Hawaii, United States
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University — Chicago, Illinois, United States
- University of Kansas Cancer Center — Fairway, Kansas, United States
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Mayo Clinic- Rochester — Rochester, Minnesota, United States
- Siteman Cancer Center — St Louis, Missouri, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Columbia University Irving Medical Center — New York, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- UNC Hospitals - Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
- University of Pittsburgh Medical Center - Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
- Tennessee Oncology — Nashville, Tennessee, United States
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- Inova Schar Cancer Institute — Fairfax, Virginia, United States
- Next Ocology — Fairfax, Virginia, United States
- Fred Hutchinson Cancer Center/University of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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