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항목
AntibodyCurated CoreFDAstaleApproved
zolbetuximab (Vyloy, IMAB362, zolbetuximab-clzb, claudiximab)
Astellas·CLDN18.2 (claudin-18.2)
26 trials
Overview
Program
Vyloy (zolbetuximab)
Overview
Company
Astellas
Overview
Modality
ANTIBODY
Overview
Target
CLDN18.2 (claudin-18.2)
Overview
Indication
CLDN18.2-positive HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma
Overview
Phase
APPROVED
Overview
Status
APPROVED
Overview
Content status
Curated Core
Overview
Data Confidence
Editorial scope · Curated Core
Overview
Development Signal
Development Signal · Established
Overview
Approval status
FDA approved
Positioning
Key differentiator
Exploits a tight-junction protein that only becomes accessible after malignant transformation, creating tumor selectivity without a novel modality.
Positioning
Known limitation
CLDN18.2 heterogeneity and loss under treatment pressure.
Positioning
Development positioning
1L with fluoropyrimidine and platinum chemotherapy
MoA
Mechanism
Binds CLDN18.2 on gastric tumor cells and kills them through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity.
MoA
Biomarker
CLDN18.2 IHC with ≥75% of tumor cells at moderate-to-strong membranous staining.
Toxicology
Major finding
Nausea and vomiting are frequent and often infusion-related, requiring rate adjustment and antiemetics. Hypoalbuminemia, appetite loss, and hypersensitivity also occur.
Toxicology
CRS
N/A
Clinical
Safety signal
Nausea and vomiting are frequent and often infusion-related, requiring rate adjustment and antiemetics. Hypoalbuminemia, appetite loss, and hypersensitivity also occur.
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts