IBI343 + capecitabine

IBI343 + capecitabine is a combination regimen consisting of IBI343, an investigational antibody-drug conjugate (ADC), and capecitabine, an oral fluoropyrimidine chemotherapy agent. IBI343 is composed of a recombinant humanized anti-claudin 18.2 (CLDN18.2) monoclonal antibody conjugated to the topoisomerase I inhibitor exatecan via a cleavable linker, utilizing site-specific glycol conjugation technology with a drug-to-antibody ratio (DAR) of 4. Capecitabine acts as a prodrug that is enzymatically converted to 5-fluorouracil (5-FU) within tumor cells, where it inhibits DNA synthesis. This combination is primarily being evaluated for the treatment of CLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC) in patients who have progressed on first-line gemcitabine-based therapy. The regimen aims to leverage the targeted delivery of a potent cytotoxic payload by the ADC while utilizing the synergistic antineoplastic effects of capecitabine to improve outcomes in CLDN18.2-expressing tumors.