NEW YORK – RedCloud Bio on Monday said the first non-small cell lung cancer patient resistant to earlier-generation EGFR tyrosine kinase inhibitors has received its investigational agent H002 in a Phase I/IIa clinical trial.
The study will involve around 76 patients with locally advanced or metastatic NSCLC harboring an active EGFR mutation, including the C797S mutation. The US Food and Drug Administration in March accepted RedCloud's investigational new drug application for this trial of H002, a fourth-generation EGFR TKI.
The first part of the trial will be a dose-escalation study to assess safety and tolerability of H002 and to establish a maximum tolerated dose, optimal biologically effective dose, and a recommended Phase II dose. Researchers will also collect data on the pharmacokinetics and antitumor activity of the drug.
In the second part of the study, RedCloud will gather safety, efficacy, and pharmacokinetic data at selected doses for patients with certain NSCLC mutations. Patients will be monitored for multiple biomarkers, which may guide future clinical trial designs for H002.
Shanghai-based RedCloud has demonstrated in preclinical studies that H002 can overcome resistance due to EGFR C797S mutations and has activity against multiple other EGFR mutations including single point mutations, double mutations, and triple mutations. The agent has shown durable antitumor activity and a favorable safety profile preclinically, and the data suggest H002 may have activity in EGFR mutation-positive brain metastases.