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Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations
Study Purpose
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.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Phase 2 Eligibility: Key Inclusion Criteria Required for locally advanced or metastatic NSCLC:
- - 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.- - 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. KeyExclusion Criteria:
Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Arms
Experimental: Phase 1 Dose Escalation - Monotherapy (Recruitment Closed)
- Advanced/metastatic NSCLC with acquired resistance EGFR mutation (eg, C797S), following a 3rd generation EGFR inhibitor in the 1st line setting (in the absence of concurrent T790M). - Advanced/metastatic NSCLC with non-classical EGFR mutation (eg, G719X) following standard-of-care therapy with an EGFR inhibitor - Recurrent GBM with confirmed EGFR alterations (including amplification, mutation, and/or variant)
Experimental: Phase 2 Cohort 1: NSCLC EGFR Non-Classical Driver Mutations
Advanced/metastatic NSCLC with a non-classical driver EGFR mutation following up to 2 lines of therapy with only 1 prior EGFR targeted regimen (third-generation preferred; other approved EGFR inhibitors acceptable)
Experimental: Phase 2 Cohort 2: NSCLC EGFR Acquired Resistance (C797S) Mutation
Advanced/metastatic NSCLC with the acquired resistance C797S EGFR mutation following up to 2 lines of therapy, including only 1 EGFR targeted regimen, which must be a third generation EGFR TKI (eg, osimertinib)
Experimental: Phase 2 Cohort 3: Treatment Naive NSCLC EGFR Non-Classical Driver Mutations
Treatment-naïve (first-line) 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.
Interventions
Drug: - silevertinib (BDTX-1535) monotherapy
Silevertinib (BDTX-1535) is a 4th generation irreversible brain penetrant EGFR MasterKey inhibitor, which targets a family of oncogenic EGFR classical and non-classical driver and resistance mutations in NSCLC.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
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University of Alabama
Birmingham, Alabama, 35294
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Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
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City of Hope Comprehensive Cancer Center (Duarte Campus)
Duarte, California, 91010
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City of Hope Huntington Beach
Huntington Beach, California, 92648
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City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
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Cedars Sinai Medical Center
Los Angeles, California, 90048
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Valkyrie Clinical Trials
Los Angeles, California, 90067
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Rocky Mountain Cancer Center
Lone Tree, Colorado, 80124
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Sibley Memorial Hospital Johns Hopkins Medicine
Washington, District of Columbia, 20016
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Mayo Clinic- Jacksonville
Jacksonville, Florida, 32224
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Miami Cancer Institute - Baptist Health South Florida
Miami, Florida, 33176
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Orlando Health Cancer Institute
Orlando, Florida, 32806
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Emory Winship Cancer Center
Atlanta, Georgia, 30322
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UHP- University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
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Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611
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Indiana University
Indianapolis, Indiana, 46202
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University of Kansas Cancer Center
Fairway, Kansas, 66205
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Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
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The Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
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Mayo Clinic- Rochester
Rochester, Minnesota, 55905
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Siteman Cancer Center
Saint Louis, Missouri, 63110
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Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
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Montefiore Medical Center
Bronx, New York, 10461
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Memorial Sloan Kettering Cancer Center
New York, New York, 10021
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Columbia University Irving Medical Center
New York, New York, 10032
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UNC Hospitals - Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
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Durham VA Medical Center
Durham, North Carolina, 27705
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Cleveland Clinic
Cleveland, Ohio, 44195
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Ohio State Comprehensive Cancer Center
Columbus, Ohio, 43210
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Thomas Jefferson University/Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
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University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
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The West Clinic PLLC, dba West Cancer Center
Germantown, Tennessee, 38138
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Tennessee Oncology
Nashville, Tennessee, 37203
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Mary Crowley Cancer Research
Dallas, Texas, 75230
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Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
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The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
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Inova Schar Cancer Institute
Fairfax, Virginia, 22031
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Next Ocology
Fairfax, Virginia, 22031
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Fred Hutchinson Cancer Center/University of Washington
Seattle, Washington, 98109
International Sites
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Princess Margaret Cancer Center- University Health Network
Toronto, Ontario, M5G 2M9
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