NEW YORK – Bridge Biotherapeutics said on Sunday that it will begin evaluating its EGFR inhibitor BBT-207 in a Phase I/II trial for patients with advanced, previously treated EGFR-mutated non-small cell lung cancer.
The US Food and Drug Administration cleared an investigational new drug application allowing the Seongnam, South Korea-based Bridge Biotherapeutics to evaluate its fourth-generation EGFR tyrosine kinase inhibitor in patients resistant to earlier generation EGFR TKIs.
Based on preclinical studies, Bridge Biotherapeutics believes BBT-207 could benefit patients with a broad range of EGFR mutations, including C797S double mutations, which commonly show up among NSCLC patients resistant to third-generation EGFR inhibitors. At the American Association for Cancer Research's annual meeting last week, Bridge Biotherapeutics shared data suggesting the drug could be active against brain metastases.
The firm's upcoming 92-patient Phase I/II trial will take place at 15 sites in the US and South Korea and have three phases. The first phase will involve dose-escalation and safety and tolerability analysis; the second phase will involve evaluating objective response rates and duration of response at the recommended dose; and in the third dose-expansion phase, Bridge will study BBT-207's antitumor activity based on RECIST criteria.