Shanghai-based RedCloud Bio announced that the first patient has been dosed in a Phase I/IIa multi-center trial of H002, its fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), for non-small cell lung cancer (NSCLC) patients with resistance to prior TKIs, including C797S mutations.
Drug Profile
H002, discovered in-house by RedCloud, targets NSCLC patients who develop resistance to earlier-generation EGFR TKIs. Preclinical studies show the drug’s efficacy against single (Del19, L858R), double (Del19/C797S, L858R/C797S), and triple (Del19/T790M/C797S) mutations, with potential to address brain metastases.
Clinical Trial Design
The Phase I/IIa study includes dose-escalation and expansion phases to evaluate H002’s antitumor activity, safety, and pharmacokinetics. Biomarkers will be monitored to guide future trial designs.
Discovery Platform
RedCloud’s drug engine combines experimental structural pharmacology, molecular dynamics, computational chemistry, and AI. H002’s development leverages this platform to target complex EGFR mutations.
Strategic Outlook
The trial marks progress in RedCloud’s pipeline, aiming to provide a novel therapy for EGFR-mutant NSCLC. The company plans to expand trials globally based on initial data.-Fineline Info & Tech
