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KD6001 + toripalimab is an investigational combination therapy under clinical evaluation for advanced melanoma. **KD6001** is a novel, fully human anti-CTLA-4 IgG1 monoclonal antibody that exerts immunomodulatory effects by enhancing T-cell-mediated anti-tumor immune response. **Toripalimab** is an approved anti–PD-1 monoclonal antibody immune checkpoint inhibitor that blocks PD-1 to promote immune system recognition and destruction of tumor cells. The combination aims to provide dual immune checkpoint blockade (CTLA-4 and PD-1 pathways) to enhance anti-tumor responses in patients with advanced melanoma, including those who have failed prior anti–PD-1/L1 therapy. As of 2025, this combination is being studied in phase 1/2 clinical trials (NCT05723432), showing acceptable safety, tolerability, and preliminary anti-tumor activity in heavily pre-treated populations, including subtypes such as mucosal melanoma[1][5][3][7][8][9].
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