A Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With First-Line Osimertinib Treatment and Harbor a C797S Mutation
Wayshine Biopharm, Inc.
Summary
This is a Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene.
Description
WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ (TKI sensitivity conferring mutation) and dual EGFRm+/C797S+ (third-generation TKI as first-line resistance conferring mutation) receptor forms of EGFR with selectivity margin over wild-type EGFR. Therefore WSD0922-FU has the potential to provide clinical benefit to patients with advanced NSCLC harboring both the single sensitivity mutations and the resistance mutation following first-line therapy with a third-generation EGFR TKI (e.g., Osimertinib). The clinical development program with WSD0922-FU will assess the safety and…