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    DRUG:

    BDTX-1535

    i
    Other names: BDTX-1535
    Company:
    Black Diamond Therap
    Drug class:
    EGFR inhibitor, EGFR MasterKey inhibitor
    Related drugs:
    4ms
    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)
    |
    BDTX-1535
    7ms
    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) • BDTX-1535
    12ms
    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) • BDTX-1535
    1year
    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)
    |
    BDTX-1535
    1year
    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)
    |
    BDTX-1535
    over2years
    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
    |
    BDTX-1535
    3years
    BDTX-1535 Goes After Osimertinib Resistance. (PubMed, Cancer Discov)
    According to a preclinical report, the investigational tyrosine kinase inhibitor BDTX-1535 may mitigate resistance to osimertinib, the standard of care for EGFR-mutant non-small cell lung cancer. It could also potentially treat central nervous system metastases, having shown preclinical efficacy in glioblastoma.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Tagrisso (osimertinib) • BDTX-1535
    3years
    [VIRTUAL] BDTX-1535, a CNS penetrant MasterKey inhibitor of common, uncommon and resistant EGFR mutations, demonstrates in vivo efficacy and has potential to treat osimertinib-resistant NSCLC with or without brain metastases (AACR-NCI-EORTC 2021)
    No abstract available
    Preclinical
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Tagrisso (osimertinib) • BDTX-1535