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This is a combination regimen consisting of four agents: ELVN-002 (a next-generation, potent, irreversible, selective, and CNS-penetrating small molecule inhibitor of HER2), trastuzumab (a recombinant humanized monoclonal antibody targeting HER2), capecitabine (an oral prodrug of 5-fluorouracil, a small molecule antimetabolite chemotherapy), and oxaliplatin (a platinum-based small molecule chemotherapeutic). This regimen is being studied experimentally for the treatment of HER2-positive or HER2-mutant advanced solid tumors, including metastatic breast cancer and non-small cell lung cancer. The aim is to provide dual HER2 inhibition while using established chemotherapies for maximal antitumor activity. ELVN-002 is designed to spare EGFR and to be CNS-penetrant, addressing brain metastases, and is being developed by Enliven Therapeutics. Trastuzumab is an established therapy for HER2-expressing cancers, acting by inhibiting HER2 signaling and mediating ADCC. Capecitabine interferes with DNA synthesis, while oxaliplatin forms DNA crosslinks inducing apoptosis[5][2][6][1].
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