Zolbetuximab

Summary

Zolbetuximab (CHEMBL2109427) is an approved antibody (ATC L01FX31) targeting CLDN18; indicated across 3 conditions including neoplasm and adenocarcinoma; with CIViC clinical evidence for 2 variant-indication associations (e.g. CLDN18 positive in gastric adenocarcinoma).

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: L01FX31
• Targets: 1 (CLDN18)
• Indications: 3 conditions
• Clinical trials: 19
• Precision-oncology evidence (CIViC): 2 variant–indication associations

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2109427
Name	Zolbetuximab
Type	Antibody
Max phase	4
ATC	L01FX31

Also known as: Claudiximab, IMAB-362, IMAB362, Vyloy, Zolbetuximab, Zolbetuximab-clzb, ZOLBETUXIMAB

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
CLDN18	claudin 18	Binding		0.3%	P56856

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): CLDN18.

Top Reactome pathways

1 total, by targets touching each:

Pathway	Targets	Genes
Tight junction interactions	1	CLDN18

Dominant GO biological processes

GO term	Targets
cell adhesion	1
negative regulation of tumor necrosis factor-mediated signaling pathway	1
calcium-independent cell-cell adhesion	1
protein localization to nucleus	1
organ growth	1
epithelial fluid transport	1
response to ethanol	1
negative regulation of bone resorption	1
lung alveolus development	1
digestive tract development	1
epithelial cell proliferation	1
bicellular tight junction assembly	1
cellular response to estrogen stimulus	1
tight junction organization	1
negative regulation of protein localization to nucleus	1

Indications & clinical

Indications

3 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
neoplasm	4	MONDO:0005070	EFO:0000616
adenocarcinoma	4	MONDO:0004970	MONDO:0003219

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 19.

Phase distribution

Phase	Trials
PHASE2	7
PHASE3	4
PHASE1	4
Not specified	3
PHASE1/PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03504397	PHASE3	ACTIVE_NOT_RECRUITING	A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
NCT03653507	PHASE3	ACTIVE_NOT_RECRUITING	A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW).
NCT06901531	PHASE3	RECRUITING	A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer
NCT07431281	PHASE3	RECRUITING	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
NCT03505320	PHASE2	ACTIVE_NOT_RECRUITING	A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer
NCT03816163	PHASE2	ACTIVE_NOT_RECRUITING	A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer
NCT06468280	PHASE2	RECRUITING	Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer
NCT06732856	PHASE1/PHASE2	RECRUITING	A Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric Cancer
NCT06881017	PHASE2	NOT_YET_RECRUITING	Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping
NCT06962137	PHASE2	RECRUITING	Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer
NCT01197885	PHASE2	COMPLETED	Efficacy and Safety Study of Multiple Doses of IMAB362 in Patients With Advanced Gastroesophageal Cancer
NCT01630083	PHASE2	COMPLETED	Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer
NCT06396091	PHASE1	ACTIVE_NOT_RECRUITING	A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer
NCT00909025	PHASE1	COMPLETED	Safety and Tolerability Study of Claudiximab in Patients With Advanced Gastroesophageal Cancer
NCT01671774	PHASE1	COMPLETED	Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer
NCT04086758	PHASE1	COMPLETED	A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
NCT06048081	Not specified	AVAILABLE	Early Access Program for Zolbetuximab
NCT06902545	Not specified	RECRUITING	A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer.
NCT03528629	Not specified	COMPLETED	A Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma

Clinical evidence (CIViC)

Variant × indication × effect (2 predictive associations from 2 curated evidence items):

Variant	Indication	Effect	Therapy	Level	CIViC
CLDN18 positive	Gastric Adenocarcinoma	Sensitivity/Response	FOLFOX-6 Regimen + Zolbetuximab	CIViC A	EID12215
CLDN18 positive	Gastric Adenocarcinoma	Sensitivity/Response	CAPOX Regimen + Zolbetuximab	CIViC A	EID12216

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).