BI 765063 + ezabenlimab + chemotherapy

BI 765063 + ezabenlimab + chemotherapy is an investigational combination regimen under clinical development for advanced solid tumors, particularly head and neck squamous cell carcinoma (HNSCC) and hepatocellular carcinoma (HCC). BI 765063 is a monoclonal antibody that acts as a selective antagonist of signal-regulatory protein alpha (SIRPα), targeting the SIRPα/CD47 pathway to enhance the anti-tumor activity of myeloid cells such as macrophages and dendritic cells. Ezabenlimab (also known as BI 754091) is a programmed cell death protein 1 (PD-1) inhibitor, classified as a checkpoint inhibitor immunotherapy. The combination with chemotherapy is designed to further improve anti-cancer immune responses and clinical efficacy, particularly in tumor types where checkpoint inhibitor monotherapy has limited benefit. This regimen is being tested in an open-label multi-arm clinical trial including patients with recurrent or metastatic HNSCC or HCC, among other solid tumors. The regimen is in early-phase clinical trials led by Boehringer Ingelheim, developed in partnership with OSE Immunotherapeutics for BI 765063[1][3].