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Therapy Name | IBI363 |
Synonyms | |
Therapy Description |
IBI363 is a bispecific antibody fusion protein comprised of a monoclonal antibody that targets PD-1 (PDCD1) linked to a modified form of IL-2, which potentially leads to decreased PD-1 signaling, elevated IL-2-dependent signaling, and restoration of the anti-tumor immune response (NCI Drug Dictionary). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
IBI363 | IBI-363|IBI 363 | PD-L1/PD-1 antibody 122 | IBI363 is a bispecific antibody fusion protein comprised of a monoclonal antibody that targets PD-1 (PDCD1) linked to a modified form of IL-2, which potentially leads to decreased PD-1 signaling, elevated IL-2-dependent signaling, and restoration of the anti-tumor immune response (NCI Drug Dictionary). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
CD274 positive | colorectal cancer | predicted - sensitive | IBI363 | Phase I | Actionable | In a Phase I trial, IBI363 treatment demonstrated safety in patients with advanced or metastatic CD274 (PD-L1)-positive (CPS>=1) colorectal cancer who had failed on or were intolerant to standard therapy (n=13) and resulted in an objective response rate of 30.8% and disease control rate of 76.9% (J Clin Oncol 42, 2024 (suppl 16; abstr 2504); NCT05460767). | detail... |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT05290597 | Phase I | IBI363 | A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or Lymphomas | Recruiting | AUS | 0 |
NCT06281678 | Phase II | IBI363 | A Study of IBI363 in Subjects With Advanced Solid Malignancies | Recruiting | USA | 0 |