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.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Phase 2 Eligibility: Key Inclusion Criteria Required for locally advanced or metastatic NSCLC: * Measurable disease by RECIST 1.1 criteria. * Adequate bone marrow or organ function. * Life expectancy of ≥ 3 months. * Sufficient performance status. * Confirmed NSCLC, without small cell lung cancer transformation with or without brain metastases. * Disease progression following or intolerance of standard of care (excluding patients in the treatment-naïve non-classical driver cohort): * Cohort 1 (Non-Classical driver cohort): Advanced/metastatic NSCLC with a non-classical driver EGFR mutation (eg, G719X) following up to 2 lines of therapy with only 1 prior EGFR TKI regimen (third-generation preferred; other approved EGFR TKI acceptable). * Cohort 2 (Acquired resistance C797S cohort): Advanced/metastatic NSCLC with the acquired resistance C797S EGFR mutation following up to 2 lines of therapy, including only one EGFR TKI, which must be a third generation EGFR TKI (eg, osimertinib). * Cohort 3 (First-line non-classical driver cohort): Treatment-naïve advanced/metastatic NSCLC with a non-classical driver EGFR mutation (1 cycle of chemotherapy or immune checkpoint inhibitor are permitted). Patients with co-occurring L858R mutations and a non-classical mutation are eligible for inclusion. * Identification of one (or more) of the following EGFR mutations by Next Generation Sequencing (NGS) as determined by a local assay performed in a validated laboratory in the absence of other known resistance mutations (eg, T790M, MET): * Non-classical driver EGFR mutations (eg, L861R, S768I, G719X). * EGFR acquired resistance mutation (eg, C797S) to a 3rd generation EGFR TKI. * For Phase 2, dose expansion, patients in Cohort 1 who received 3rd generation EGFR TKI (eg, osimertinib), the NGS report within 6 months prior to the start of Screening is acceptable. For patients in Cohort 2, the NGS report must be from the last disease progression on the immediate prior therapy. For patients in Cohort 3, the NGS report must be at the time of diagnosis. Key Exclusion Criteria: * Known resistant mutations in tumor tissue or by liquid biopsy (eg, T790M, MET). * Received more than 1 EGFR TKI therapy (ie, erlotinib or gefitinib) for the treatment of metastatic or recurrent EGFR NSCLC. * Any history of interstitial lung disease related to EGFR TKI use. * Symptomatic or radiographic leptomeningeal disease. * Symptomatic brain metastases or spinal cord compression requiring urgent clinical intervention. * Unresolved toxicity from prior therapy. * Significant cardiovascular disease. * Major surgery within 4 weeks of study entry or planned during study. * Ongoing or recent anticancer therapy or radiation therapy. * Evidence of malignancy (other than study-specific malignancies) requiring active therapy within the next 2 years. * Active hepatitis B or C infection and/or known human immunodeficiency virus (HIV) carrier. * Poorly controlled gastrointestinal disorders.
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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
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