marked.bio

EGFR TKI (4th generation) · small molecule

silevertinib

3 active trials, targeting EGFR. Not approved for any biomarker on marked.bio yet.

Also known as BDTX-1535.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
EGFR exon 19 deletion / L858R 3 3 Phase 2

Sponsors

Industry sponsors leading active biomarker-selected trials of silevertinib.

  1. Black Diamond Therapeutics 2

Trials

3 of 3 trials shown

  1. Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII

    Recruiting Phase 2 Black Diamond Therapeutics Started 2026Primary completion 2028-11 NCT07326566

    silevertinibtemozolomide

    For Part 1 (Safety Lead-in) ONLY: EGFR alterations.

    EGFR exon 19 deletion / L858RGlioblastoma (GBM), Newly Diagnosed Glioblastoma, GBM, Glioblastoma Multiforme (GBM)

  2. Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations

    Active, not recruiting Phase 1/2 Black Diamond Therapeutics Started 2022Primary completion 2025-11 NCT05256290

    silevertinib

    …ed 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 ge…

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer, Advanced Non-Small Cell Squamous Lung Cancer, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Lung Cancer

  3. 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

    Recruiting Early Phase 1 St. Joseph's Hospital and Medical Center, Phoenix Started 2023Primary completion 2027-12 NCT06072586

    silevertinibtemozolomide

    The tissue must have evidence of EGFR alterations including variants, fusion, and mutations with or without amplifications. rHGG participan…

    EGFR exon 19 deletion / L858RHigh Grade Glioma, Glioblastoma