Clinical-stage biopharmaceutical company Nuvalent, Inc. (Nasdaq:NUVL) announced on Monday the initiation of HEROEX-1, a Phase 1a/1b clinical trial for NVL-330.

NVL-330 is a novel HER2-selective inhibitor targeting HER2-altered non-small cell lung cancer (NSCLC) in pre-treated patients. HER2 alterations, including exon 20 mutations, are key oncogenic drivers in NSCLC with no approved TKIs for this patient population. NVL-330 aims to address this by maintaining activity against HER2 exon 20 mutations, limiting EGFR-related toxicities, and penetrating the brain to tackle metastases.

HEROEX-1 will evaluate NVL-330's safety, tolerability, recommended Phase 2 dose, pharmacokinetic profile and preliminary anti-tumor activity.

This trial involves a multicenter, open-label, dose-escalation and expansion study design. NVL-330's differentiated preclinical profile supports its potential efficacy in this clinical investigation.