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    DRUG CLASS:

    EGFR MasterKey inhibitor

    Related drugs:
    14d
    A Phase 0/1 Study of BDTX-1535 in Recurrent High-Grade Glioma (rHGG) and Newly Diagnosed Glioblastoma (nGBM) Participants With EGFR Alterations or Fusions (clinicaltrials.gov)
    P1, N=82, Recruiting, St. Joseph's Hospital and Medical Center, Phoenix | Trial completion date: Sep 2027 --> Dec 2027 | Trial primary completion date: Sep 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    temozolomide • silevertinib (BDTX-1535)
    5ms
    BDTX-1535-101: Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations (clinicaltrials.gov)
    P1/2, N=200, Active, not recruiting, Black Diamond Therapeutics, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    EGFR mutation • EGFR L858R • EGFR T790M • EGFR G719X
    |
    Tagrisso (osimertinib) • silevertinib (BDTX-1535)
    7ms
    Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions (clinicaltrials.gov)
    P1, N=82, Recruiting, St. Joseph's Hospital and Medical Center, Phoenix | N=34 --> 82 | Trial completion date: Oct 2025 --> Sep 2027 | Trial primary completion date: May 2025 --> Sep 2026
    Enrollment change • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    temozolomide • silevertinib (BDTX-1535)
    over1year
    Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions (clinicaltrials.gov)
    P1, N=34, Recruiting, St. Joseph's Hospital and Medical Center, Phoenix | N=22 --> 34
    Enrollment change
    |
    EGFR (Epidermal growth factor receptor)
    |
    silevertinib (BDTX-1535)
    over1year
    Phase 1/2 Study of BDTX-1535 in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations (clinicaltrials.gov)
    P1/2, N=200, Recruiting, Black Diamond Therapeutics, Inc. | Trial completion date: Mar 2025 --> Jun 2026 | Trial primary completion date: Jun 2024 --> Jul 2025
    Trial completion date • Trial primary completion date
    |
    Tagrisso (osimertinib) • silevertinib (BDTX-1535)
    almost2years
    Phase 1/2 Study of BDTX-1535 in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations (clinicaltrials.gov)
    P1/2, N=200, Recruiting, Black Diamond Therapeutics, Inc. | Phase classification: P1 --> P1/2 | N=120 --> 200
    Phase classification • Enrollment change
    |
    EGFR mutation • EGFR L858R • EGFR T790M • EGFR C797S • EGFR G719X
    |
    Tagrisso (osimertinib) • silevertinib (BDTX-1535)
    2years
    Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions (clinicaltrials.gov)
    P1, N=22, Recruiting, St. Joseph's Hospital and Medical Center, Phoenix | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor)
    |
    silevertinib (BDTX-1535)
    2years
    Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions (clinicaltrials.gov)
    P1, N=22, Not yet recruiting, St. Joseph's Hospital and Medical Center, Phoenix
    New P1 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    silevertinib (BDTX-1535)