Drug intelligence / Profile preview

TST001 + nivolumab

Development stage
Unknown
Lead developer
Transcenta
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

TST001 + nivolumab is a **combination therapy** composed of TST001 (osemitamab), a high-affinity humanized monoclonal antibody targeting claudin 18.2 (CLDN18.2), and nivolumab, a programmed cell death protein 1 (PD-1) immune checkpoint inhibitor. TST001 exerts its antitumor effects through **NK cell-mediated antibody-dependent cellular cytotoxicity (ADCC)** against CLDN18.2-expressing tumor cells, whereas nivolumab blocks the PD-1 pathway to enhance T cell-mediated antitumor immunity. This combination, often given with chemotherapy (e.g., CAPOX), is being evaluated in advanced or metastatic **HER2-negative gastric and gastroesophageal junction (G/GEJ) adenocarcinoma**. Early-phase trials have shown that the regimen is generally safe and well-tolerated, with encouraging antitumor efficacy regardless of PD-L1 or CLDN18.2 status[1][2][4][5].

Brand names
Opdivo
Other names
TST001 + nivolumabosemitamab + nivolumabTST001 plus nivolumabTST-001 plus nivolumabTST 001 plus nivolumab
02

Targets

Claudin 18.2PDCD1 (Programmed cell death protein 1 receptor)

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