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Clinical Trial Summary

This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of BLU-945, a selective EGFR inhibitor, as monotherapy or in combination with osimertinib.


Clinical Trial Description

The study will include an initial Phase 1 portion to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BLU-945 as monotherapy (initially in a QD regimen with the option to evaluate BID dosing, if supported by emerging PK and safety data), as well as an additional dose-escalation portion to determine the RP2D of BLU-945 in combination with osimertinib. The BLU-945 monotherapy Phase 2 expansion groups will consist of patients with tumors harboring specific mutation profiles (EGFR T790M and C797S mutation [Group 1]; EGFR T790M but not C797S [Group 2]; or EGFR C797S but not T790M [Group 3]). The BLU-945 with osimertinib Phase 2 expansion (Group 4) will include approximately 24 evaluable patients, with at least 12 slots reserved for patients with EGFR T790M and C797S mutation. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Antineoplastic Agents
  • Bronchial Neoplasms
  • Carcinoma
  • Carcinoma, Bronchogenic
  • Carcinoma, Non-Small-Cell Lung
  • EGF-R Positive Non-Small Cell Lung Cancer
  • EGFR Activating Mutation
  • EGFR Gene Mutation
  • EGFR T790M
  • Lung Diseases
  • Lung Neoplasms
  • Neoplasms
  • Neoplasms by Histologic Type
  • Neoplasms by Site
  • Neoplasms, Nerve Tissue
  • Protein Kinase Inhibitors
  • Respiratory Tract Disease
  • Respiratory Tract Diseases
  • Respiratory Tract Neoplasms
  • Thoracic Neoplasms

NCT number NCT04862780
Study type Interventional
Source Blueprint Medicines Corporation
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date June 29, 2021
Completion date January 31, 2025

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