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A combination therapy consisting of **INCB001158** (an oral arginase inhibitor), **gemcitabine** (a nucleoside analog antimetabolite), and **cisplatin** (a platinum-based DNA alkylating agent), evaluated for its safety, tolerability, and antitumor activity primarily in patients with advanced or metastatic solid tumors including biliary tract cancers. INCB001158 acts by inhibiting arginase 1 in the tumor microenvironment, thereby increasing local arginine levels, reversing immune suppression, and potentially enhancing T cell-mediated antitumor immunity. The combination is designed to leverage immunomodulation (by arginase inhibition) alongside standard cytotoxic chemotherapy[4][6][10].
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