GI-102 + doxorubicin

GI-102 + doxorubicin is an **investigational combination therapy** for advanced and metastatic solid tumors, currently under evaluation in phase 1/2 clinical trials. GI-102 is a novel bispecific Fc fusion protein engineered to combine the immunomodulatory properties of the CD80 ectodomain with an interleukin-2 (IL-2) variant, joined via a human IgG4 Fc. The CD80 component targets tumor and immune cells and inhibits CTLA-4 on regulatory T cells (Tregs). The modified IL-2 is designed to minimize activation of Tregs by losing IL-2Rα binding, while strongly promoting proliferation and activation of NK and CD8+ T cells via IL-2Rβγ, thus enhancing anti-tumor immunity. When combined with doxorubicin, a conventional anthracycline chemotherapeutic agent that intercalates DNA and inhibits topoisomerase II, the regimen aims to maximize immunogenic cell death and immune activation by integrating GI-102’s immune enhancement with doxorubicin's cytotoxic effects. This combination is being developed primarily for patients with advanced/metastatic solid tumors, including those refractory to standard immuno-oncology agents[1][2][3][4].