Drug intelligence / Profile preview

TST001 + nivolumab + chemotherapy

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

Overview

Triple combination therapy of **TST001** (osemitamab, a high-affinity humanized monoclonal antibody targeting Claudin 18.2), **nivolumab** (an anti-PD-1 monoclonal antibody), and **chemotherapy** (typically capecitabine and oxaliplatin, CAPOX regimen, or 5-fluorouracil, folinic acid, and oxaliplatin, mFOLFOX6) for the first-line treatment of HER2-negative, locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. *TST001* works via ADCC (antibody-dependent cellular cytotoxicity) targeting CLDN18.2, while nivolumab blocks PD-1 to enhance the immune response; chemotherapy provides cytotoxic antineoplastic effects. This combination is under Phase 3 clinical evaluation, has demonstrated promising efficacy (including in CLDN18.2 high/medium and PD-L1 negative tumors), and an acceptable safety profile. Developed primarily by Transcenta, with nivolumab developed by Bristol Myers Squibb[1][2][3][5][7].

Brand names
Opdivo
Other names
osemitamab + nivolumab + chemotherapy
02

Targets

DNAClaudin 18.2PDCD1 (Programmed cell death protein 1 receptor)

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