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    DRUG:

    silevertinib (BDTX-1535)

    i
    Other names: BDTX-1535
    Company:
    Black Diamond Therap
    Drug class:
    EGFR inhibitor, 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
    Overcoming triple mutant EGFR-tyrosine kinase barriers in the therapeutics of non-small cell lung cancer: a patent review on fourth-generation inhibitors (2017-2024). (PubMed, Expert Opin Ther Pat)
    This review highlights the significance of fourth-generation EGFR tyrosine kinase inhibitors (EGFR-TKIs) in addressing acquired resistance mechanisms, such as the C797S mutation, which compromises the efficacy of third-generation inhibitors like Osimertinib and explores their potential to revolutionize NSCLC treatment through enhanced molecular specificity. Preclinical trials highlight the potential of sulfonyl and phosphine oxide-based compounds for their potency, selectivity, and favorable pharmacokinetics. Promising clinical trials with inhibitors like BDTX-1535, JIN-A02, and HS-10504 could redefine NSCLC treatment, with future success likely relying on innovative strategies, such as combination therapies, to combat resistance and enhance efficacy.
    Review • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR T790M
    |
    Tagrisso (osimertinib) • JIN-A02 • 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)
    8ms
    A clinical review on third and fourth generation EGFR tyrosine kinase inhibitors for the treatment of non-small cell lung cancer. (PubMed, Bioorg Med Chem)
    This review delves into the current clinical status, efficacy, safety profiles, and regulatory approvals of third-generation EGFR TKIs, including Osimertinib, Lazertinib, Furmonertinib, Aumolertinib, Rezivertinib, Befotertinib, Sunvozertinib...Notable fourth-generation candidates such as TQB3804, BPI-361175, BDTX-1535, WJ13404, QLH11811, H002, HS-10375, BBT-207, JIN-A02, and HS-10504 are highlighted for their potential to overcome the C797S mutation...By evaluating the therapeutic potential and limitations of these EGFR TKIs, this review aims to guide future research in the management of EGFR-mutant NSCLC. This acts as guiding beacon for the strategic design and development of third and fourth generation EGFR-TK inhibitors to overcome the drug resistance hurdles in the development of EGFR-TK inhibitors.
    Review • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M
    |
    Tagrisso (osimertinib) • Ameile (aumolertinib) • Ivesa (firmonertinib) • Lazcluze (lazertinib) • JIN-A02 • silevertinib (BDTX-1535) • Semena (befotertinib) • Zegfrovy (sunvozertinib) • Rui Bi Da (rezivertinib) • BPI-361175 • BBT-207 • HS-10375 • QLH11811 • TQB3804
    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)
    over3years
    Anti-tumor activity of BDTX-1535, an irreversible CNS penetrant inhibitor of multiple EGFR extracellular domain alterations, in preclinical glioblastoma models (AACR-NCI-EORTC 2022)
    RWE findings demonstrate a heterogeneous EGFR mutational profile in GBM patients, with persistent prevalence over time. BDTX-1535 is currently in a phase I clinical study (NCT05256290).
    Preclinical
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR amplification • EGFR wild-type • EGFR mutation + EGFR amplification • EGFRvIII expression
    |
    Tempus xT Assay
    |
    silevertinib (BDTX-1535)