# Zolbetuximab

Source: https://onco.cc/drugs/zolbetuximab/  
OnCo record `zolbetuximab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Zolbetuximab is the first drug against Claudin 18.2, a protein exposed on stomach cancer cells. Added to chemotherapy it extends survival by two to three months; nausea is the price.

## Summary

Chimeric IgG1 binding CLDN18.2, killing via ADCC and CDC. SPOTLIGHT and GLOW positive; FDA approval 18 October 2024 with a companion IHC assay (VENTANA CLDN18). Eligible patients are CLDN18.2 ≥75% moderate-to-strong membranous staining, HER2-negative. Nausea and vomiting occur in most patients in cycle 1 and need aggressive antiemetic prophylaxis and infusion-rate adjustment.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Vyloy
- Code: IMAB362
- Modality: Monoclonal antibody (anti-Claudin 18.2)
- Mechanism: Binds CLDN18.2 exposed on malignant gastric cells; Fc-mediated ADCC and complement-dependent cytotoxicity.
- Approvals: Japan 2024: CLDN18.2+ HER2- gastric cancer (first approval, March 2024); US 2024: First-line CLDN18.2+ (≥75%), HER2- locally advanced/metastatic gastric or GEJ adenocarcinoma with fluoropyrimidine/platinum chemotherapy; EU 2024: 1L CLDN18.2+ HER2- gastric/GEJ; 19 Sep 2024
- Dosing: Intravenous; 800 mg/m² loading, then 600 mg/m² every 3 weeks or 400 mg/m² every 2 weeks with chemotherapy

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Zolbetuximab
- FDA label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761365s000lbl.pdf

## Connected records

- biomarkers: [Claudin 18.2 expression (>= 75% of tumour cells, moderate to strong)](https://onco.cc/biomarkers/cldn18-2-expression/)
- cancers: [Claudin 18.2-positive gastric cancer](https://onco.cc/cancers/gastric-cldn18-2-positive/), [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [Oesophageal and junctional adenocarcinoma](https://onco.cc/cancers/oesophageal-adenocarcinoma/), [Oesophageal cancer](https://onco.cc/cancers/esophageal/), [PD-L1-high gastric cancer](https://onco.cc/cancers/gastric-pdl1-high/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- targets: [Claudin 18.2](https://onco.cc/targets/cldn18-2/)
- companies: [Astellas](https://onco.cc/companies/astellas/)
- terms: [ADCC (antibody-dependent cellular cytotoxicity)](https://onco.cc/terms/adcc/)
- trials: [A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer](https://onco.cc/trials/nct03505320/), [A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer](https://onco.cc/trials/nct03816163/), [A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer](https://onco.cc/trials/nct06901531/), [Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2](https://onco.cc/trials/nct07431281/), [SPOTLIGHT & GLOW](https://onco.cc/trials/spotlight-glow/)
- pairings: [CLDN18.2 antibody first line → CLDN18.2 ADC or CAR-T on progression](https://onco.cc/pairings/cldn18-antibody-then-adc/)
- ideas: [Biomarker-directed first-line quadruplets in gastric cancer](https://onco.cc/ideas/idea-biomarker-quadruplet-gastric/)
- people: [Jeeyun Lee](https://onco.cc/people/lee-jeeyun/), [Kohei Shitara](https://onco.cc/people/shitara-kohei/), [Min-Hee Ryu](https://onco.cc/people/ryu-min-hee/), [Sun Young Rha](https://onco.cc/people/rha-sun-young/), [Yoon-Koo Kang](https://onco.cc/people/kang-yoon-koo/)
- key papers: [GLOW: zolbetuximab plus CAPOX in claudin 18.2-positive, HER2-negative gastric or gastro-oesophageal junction adenocarcinoma](https://onco.cc/key-papers/paper-glow-zolbetuximab-nat-med-2023/)
- pathways: [Gastric cancer (KEGG map)](https://onco.cc/pathways/gastric-cancer-signalling/)

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