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IBI363 + investigator's choice SOC is a combination therapy consisting of IBI363, a first-in-class PD-1/IL-2 α-bias bispecific antibody fusion protein, administered together with the standard of care (SOC) as determined by the clinical investigator for each patient. IBI363 is designed to block the PD-1 immune checkpoint and selectively activate IL-2 signaling in tumor-specific T cells by cis-targeting IL-2α (CD25), thereby rejuvenating exhausted T cells and enhancing antitumor immunity. The IL-2 arm maintains affinity for IL‑2Rα while reducing binding to IL‑2Rβ and γ, aiming to minimize toxicity compared to traditional IL‑2 therapies. The combination with SOC allows tailored treatment regimens based on current best practices for specific cancer types or patient populations. This approach has shown promising efficacy and manageable safety in early-phase trials across multiple advanced solid tumors, including melanoma, non-small cell lung cancer (NSCLC), colorectal cancer, biliary tract cancer (BTC), head and neck squamous cell carcinoma (HNSCC), cervical cancer, and ovarian cancer[1][5][7].
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