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ruzaltatug rezetecan + almonertinib
- Development stage
- Phase 2
- Lead developer
- Hengrui Therapeutics
- Modality
- Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Small Molecules
- Administration
- Intravenous, Oral
01
Overview
ruzaltatug rezetecan + almonertinib is an investigational combination regimen under clinical development for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). The regimen combines ruzaltatug rezetecan (SHR-A2009), a human epidermal growth factor receptor 3 (HER3)-directed antibody-drug conjugate (ADC) carrying a topoisomerase I inhibitor payload (rezetecan), with almonertinib (aumolertinib), an approved oral third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). By simultaneously inhibiting EGFR signaling and targeting HER3—which is frequently upregulated as a resistance mechanism following EGFR TKI therapy—the combination aims to overcome resistance and enhance antitumor efficacy. The combination is currently being evaluated in a Phase III clinical trial (NCT07183189) as a first-line treatment for patients with EGFR-mutated, locally advanced or metastatic NSCLC.
- Other names
- almonertinib + ruzaltatug rezetecanalmonertinib + SHR-A2009aumolertinib + ruzaltatug rezetecanaumolertinib + SHR-A2009ruzaltatug rezetecan + aumolertinibSHR-A2009 + almonertinibSHR-A2009 + aumolertinib
02
Targets
EGFR (Epidermal growth factor receptor)ERBB3 (Erb-b2 receptor tyrosine kinase 3)
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