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givastomig + nivolumab
- Development stage
- Unknown
- Lead developer
- ABL Bio
- Modality
- Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
- Administration
- Intravenous
01
Overview
Givastomig + nivolumab is an investigational combination immunotherapy regimen being evaluated for the first-line treatment of Claudin 18.2 (CLDN18.2)-positive, HER2-negative advanced or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinomas. Givastomig (formerly TJ033721 or ABL111) is a bispecific antibody designed to target CLDN18.2 on tumor cells and conditionally activate T cells via the 4-1BB (CD137) costimulatory pathway within the tumor microenvironment, thereby minimizing systemic hepatotoxicity. Nivolumab (Opdivo) is a fully human IgG4 monoclonal antibody that acts as an immune checkpoint inhibitor by binding to the programmed death-1 (PD-1) receptor, blocking its interaction with PD-L1 and PD-L2 to restore anti-tumor T-cell activity. The combination, typically administered alongside chemotherapy (such as mFOLFOX6 or CAPOX), is currently in Phase 2 clinical development under NovaBridge Biosciences (formerly I-Mab) and ABL Bio, with a registrational Phase 3 trial planned.
- Other names
- ABL111 + OpdivoABL111 + nivolumabTJ033721 + OpdivoTJ033721 + nivolumabgivastomig + Opdivogivastomig plus Opdivogivastomig plus nivolumab
02
Targets
CD274 (Programmed cell death protein 1 ligand 1)Claudin 18.2PDCD1 (Programmed cell death protein 1 receptor)PDCD1LG2 (Programmed cell death 1 ligand 2)TNFRSF9 (CD137 extracellular domain)
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