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A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients With Glioblastoma or Non-Small Cell Lung Cancer

  • Protocol Number: 202211002
  • Principal Investigator: Chen, Haobin
  • Cancer Types: Lung

Learn more about this study at: clinicaltrials.gov

For more information on this trial, contact us here:

Phone
800-600-3606
Email
[email protected]

Brief Summary

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 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 multiforme (GBM) expressing EGFR alterations (Phase 1 only). All patients will self administer BDTX-1535 monotherapy by mouth in 21-day cycles.

Phase 1 enrollment is now complete. Phase 2 is currently enrolling.

Protocol Interventions

BDTX-1535 monotherapy