ELVN-002 + trastuzumab + capecitabine

ELVN-002 + trastuzumab + capecitabine is an investigational combination regimen comprising three agents: - **ELVN-002**: a potent, highly selective, irreversible, central nervous system penetrant small molecule inhibitor of HER2 (ERBB2), targeting both wild-type HER2 and a broad spectrum of HER2 mutations. Designed to spare wild-type EGFR, ELVN-002 aims to reduce off-target toxicity and overcome resistance mechanisms in HER2-driven cancers. - **Trastuzumab**: a monoclonal antibody that binds the extracellular domain of HER2, mediating antibody-dependent cellular cytotoxicity and inhibiting downstream signaling. - **Capecitabine**: an oral prodrug converted to 5-fluorouracil, which inhibits DNA synthesis in rapidly dividing tumor cells. This regimen is under investigation primarily for HER2-positive and HER2-mutant advanced/metastatic solid tumors, especially breast cancer and non-small cell lung cancer. ELVN-002 in particular is being tested in combination with approved agents for patients with disease progression after standard anti-HER2 therapies. The combination leverages vertical HER2 blockade (small molecule + antibody) alongside cytotoxic chemotherapy to maximize antitumor efficacy[1][5][3].