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sintilimab + ipilimumab + nab-paclitaxel + gemcitabine
- Development stage
- Unknown
- Lead developer
- Innovent Biologics
- Modality
- Nanoparticles → Drug Delivery Systems, Small Molecules, Monoclonal Antibodies → Antibody-Based Therapeutics
- Administration
- Intravenous
01
Overview
Sintilimab + Ipilimumab + AG is an investigational combination regimen being evaluated as a first-line therapy for unresectable locally advanced or metastatic biliary tract malignancies. The regimen consists of two monoclonal antibodies—sintilimab (a PD-1 inhibitor) and ipilimumab (a CTLA-4 inhibitor)—and two chemotherapy agents—albumin-bound paclitaxel (nab-paclitaxel) and gemcitabine (collectively known as the AG regimen). Sintilimab is a fully human IgG4 monoclonal antibody that blocks the PD-1/PD-L1 interaction, while ipilimumab is a human IgG1 monoclonal antibody that targets CTLA-4. The combination of dual checkpoint blockade with cytotoxic chemotherapy is designed to enhance anti-tumor immune responses and provide direct cytotoxic effects. This four-drug protocol is currently being studied in a Phase II clinical trial sponsored by Tianjin Medical University Cancer Institute and Hospital.
- Other names
- Sintilimab + Ipilimumab + AGSintilimab + Ipilimumab + nab-paclitaxel + gemcitabineSintilimab Combined With Ipilimumab (N01) Plus Albumin-bound Paclitaxel and Gemcitabine (AG)
02
Targets
TUBB (Tubulin (alpha and beta subunits))PDCD1 (Programmed cell death protein 1 receptor)CTLA-4 (Cytotoxic t-lymphocyte–associated protein 4)DNA
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