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zanidatamab + zongertinib
- Development stage
- Phase 2
- Lead developer
- Boehringer Ingelheim
- Modality
- Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Small Molecules
- Administration
- Intravenous, Oral
01
Overview
Zanidatamab + zongertinib is an investigational combination of two HER2-directed agents being evaluated for the treatment of HER2-driven cancers, including HER2-positive breast cancer and HER2-mutated non-small cell lung cancer (NSCLC). Zanidatamab is a humanized bispecific monoclonal antibody that binds to two non-overlapping extracellular domains of HER2 (ECD2 and ECD4), promoting receptor clustering, internalization, and immune-mediated cytotoxicity. Zongertinib is an oral, highly selective, irreversible tyrosine kinase inhibitor (TKI) that targets the intracellular kinase domain of HER2 while sparing wild-type EGFR. By combining these two agents, the regimen achieves dual HER2 blockade, inhibiting HER2 signaling both extracellularly and intracellularly to overcome or delay resistance.
- Other names
- zongertinib + zanidatamab
02
Targets
NeuraminidaseFcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)Human epidermal growth factor receptor 2 (HER2) extracellular domain IIHuman epidermal growth factor receptor 2 (HER2) extracellular domain IVERBB2 (Erb-b2 receptor tyrosine kinase 2)
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