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A combination investigational therapy of TRX518, cyclophosphamide, and avelumab designed for solid tumor immuno-oncology applications. **TRX518** is a novel, humanized monoclonal antibody targeting glucocorticoid-induced TNF receptor-related protein (GITR), acting as an agonist to enhance anti-tumor immune responses by activating effector T cells and reducing immunosuppressive regulatory T cells. **Cyclophosphamide** is an alkylating chemotherapeutic agent that also has immunomodulatory effects, enhancing cancer immunotherapy outcomes. **Avelumab** is a fully human IgG1 monoclonal antibody acting as a programmed death ligand 1 (PD-L1) inhibitor (immune checkpoint inhibitor), restoring anti-tumor T cell activity. The combination is studied for synergistic immunomodulatory effects in advanced solid tumors, including a Phase 1 trial for advanced solid tumors and disease-refractory cancer, aiming to overcome immune resistance using complementary mechanisms of stimulated T-cell immunity, immune checkpoint blockade, and immunomodulation.
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