New pill targets tough cancers: early trial underway
NCT ID NCT05256290
First seen Jun 26, 2026 · Last updated Jul 23, 2026 · Updated 3 times
Summary
This study tests an experimental oral drug called silevertinib (BDTX-1535) in about 200 adults with advanced non-small cell lung cancer or glioblastoma, a type of brain cancer. The drug is designed to block specific EGFR mutations that help these cancers grow. The trial has two phases: Phase 1 determined the safest dose, and Phase 2 is now checking how well the drug shrinks tumors. Participants take the drug daily in 21-day cycles.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Silevertinib (BDTX-1535), an oral drug that targets specific EGFR mutations in cancer cells
- What this could lead to
- If successful, this could provide a new treatment option for people with certain types of lung cancer or brain tumors that have not responded to other therapies.
- What could go wrong
- This is an early-phase trial (Phase 1/2) with a small number of participants. The drug may not work as hoped, and side effects could be significant. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
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Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
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City of Hope Huntington Beach
Huntington Beach, California, 92648, United States
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City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618, United States
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Columbia University Irving Medical Center
New York, New York, 10032, United States
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
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Fred Hutchinson Cancer Center/University of Washington
Seattle, Washington, 98109, United States
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Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
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Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
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Mayo Clinic- Jacksonville
Jacksonville, Florida, 32224, United States
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Mayo Clinic- Rochester
Rochester, Minnesota, 55905, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
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Miami Cancer Institute - Baptist Health South Florida
Miami, Florida, 33176, United States
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Montefiore Medical Center
The Bronx, New York, 10461, United States
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Next Ocology
Fairfax, Virginia, 22031, United States
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Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611, United States
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Sibley Memorial Hospital Johns Hopkins Medicine
Washington D.C., District of Columbia, 20016, United States
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Siteman Cancer Center
St Louis, Missouri, 63110, United States
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Tennessee Oncology
Nashville, Tennessee, 37203, United States
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The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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UHP- University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
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UNC Hospitals - Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514, United States
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University of Alabama
Birmingham, Alabama, 35294, United States
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University of Kansas Cancer Center
Fairway, Kansas, 66205, United States
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University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new immunotherapy combo outsmart advanced lung cancer?
- Double attack on mutant KRAS: can two targeted drugs outsmart resistant cancers?
- Can a pill keep lung cancer from returning after surgery?
- New imaging clues could sharpen brain tumor monitoring
- Seeing the fight: new imaging tracer may reveal how immune cells attack lung cancer
- Could a bronchial wash detect lung cancer mutations faster?