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Combination of **copanlisib**, a potent reversible pan-class I phosphoinositide 3-kinase (PI3K) inhibitor with predominant activity against PI3K-α and PI3K-δ isoforms, plus **cisplatin** and **gemcitabine**, two standard cytotoxics. This regimen has been investigated for safety and efficacy in advanced solid tumors, especially biliary tract cancer (BTC) and cholangiocarcinoma. Copanlisib inhibits the PI3K/AKT pathway, supporting the hypothesis that this pathway’s blockade may sensitize tumors to DNA-damaging chemotherapy. Clinical studies evaluating this triple combination as first-line therapy in advanced BTC did not show improved survival over standard-of-care chemotherapy, although some objective responses were observed in early-phase trials. Copanlisib is developed by Bayer, and cisplatin/gemcitabine are established generics[1][2][3][4][5].
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