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항목
AntibodyCurated CoreFDAApproved
zolbetuximab (Vyloy, IMAB362, zolbetuximab-clzb, claudiximab)
Astellas·CLDN18.2 (claudin-18.2)
26 trials·t½ ~11 days
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
Data Confidence · High
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
Only approved CLDN18.2 agent; CAR-T and ADC competitors are still in trials.
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.
PK/PD
Half-life
~11 days
PK/PD
Animal (cat.)
Human, In vitro
PK/PD
Experiment
pharmacokinetic
Toxicology
Species
Mouse
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
Selected reported efficacy
48.1%
Clinical
Result source
SPOTLIGHT (NCT03504397) / GLOW (NCT03653507)
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT03504397
Preclinical
Animal (cat.)
Mouse, In vitro