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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

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Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 23 Jul 2025

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At a glance

  • Drugs Silevertinib (Primary) ; Temozolomide
  • Indications Glioblastoma; Non-small cell lung cancer
  • Focus Adverse reactions; First in man; Proof of concept; Therapeutic Use
  • Sponsors Black Diamond Therapeutics

Most Recent Events

  • 11 Jul 2025 Status changed from recruiting to active, no longer recruiting.
  • 12 May 2025 According to a Black Diamond Therapeutics media release, in 4Q of 2025 company expects to disclose initial Phase 2 clinical data for BDTX-1535 in newly diagnosed patients with non-small cell lung cancer (NSCLC) and plans to solicit U.S. Food and Drug Administration (FDA) feedback on a potential pivotal registrational path.
  • 07 Mar 2025 According to a Black Diamond Therapeutics media release, company planning to solicit U.S. Food and Drug Administration (FDA) feedback on a potential pivotal registrational path for BDTX-1535 in newly diagnosed EGFRm NSCLC patients in the second half of 2025.

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