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REGN1400 + erlotinib is an investigational combination therapy comprising REGN1400, a fully human monoclonal antibody targeting ErbB3 (HER3), and erlotinib, an EGFR inhibitor. REGN1400 selectively binds ERBB3, blocking activation by its ligand neuregulin 1, and consequently inhibits downstream Akt signaling essential for cell survival. Erlotinib is a small molecule inhibitor that blocks EGFR tyrosine kinase activity, primarily inhibiting ERK-mediated proliferation pathways. Preclinical studies show augmented anti-tumor effects when both HER3 and EGFR are inhibited simultaneously. The combination is primarily developed for advanced non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and squamous cell carcinoma of the head and neck (SCCHN), especially in patients progressing on prior EGFR inhibitors. Clinical trials indicate that the regimen is generally well-tolerated; adverse events most commonly include rash, diarrhea, nausea, and fatigue. The recommended phase 2 dose for REGN1400 is 20 mg/kg IV every two weeks.
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