Drug intelligence / Profile preview

givastomig + nivolumab + oxaliplatin + leucovorin + fluorouracil

Development stage
Phase 2
Lead developer
ABL Bio
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous
01

Overview

Givastomig + nivolumab + oxaliplatin + leucovorin + fluorouracil is an investigational combination chemoimmunotherapy regimen under clinical development for the treatment of Claudin 18.2 (CLDN18.2)-positive gastrointestinal malignancies, including gastric, gastroesophageal junction, and esophageal adenocarcinomas. The regimen combines givastomig (TJ033721/ABL111), a bispecific antibody that simultaneously targets CLDN18.2 on tumor cells and conditionally activates T cells via the 4-1BB (CD137) pathway in the tumor microenvironment, with the anti-PD-1 checkpoint inhibitor nivolumab and the standard mFOLFOX6 chemotherapy backbone (oxaliplatin, leucovorin, and fluorouracil). By combining localized 4-1BB agonism, systemic immune checkpoint blockade, and cytotoxic chemotherapy, the regimen aims to synergistically enhance anti-tumor immune responses and overcome immunosuppressive tumor microenvironments while minimizing systemic toxicities. The combination is being evaluated in Phase 1b and Phase 2 clinical trials (such as the GIVA-2 study).

Other names
givastomig + nivolumab + FOLFOXgivastomig + nivolumab + chemotherapygivastomig + nivolumab + mFOLFOX6givastomig + nivolumab + mFOLFOX6 regimen
02

Targets

Claudin 18.2DNAPDCD1 (Programmed cell death protein 1 receptor)CD274 (Programmed cell death protein 1 ligand 1)TS (Thymidylate synthase)TNFRSF9 (CD137 extracellular domain)

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