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항목
ADCCurated CoreFDAApproved
enfortumab vedotin (Padcev, ASG-22ME, enfortumab-vedotin-ejfv)
Astellas / Pfizer (Seagen)·Nectin-4
201 trials·t½ ADC ~3.4 days; free MMAE ~2.4 days
CGTLimited DatastalePhase 1
CAR-T therapy for nectin4-positive malignant solid tumor (CAR-T therapy for nectin4-positive malignant solid tumor)
The Sixth Affiliated Hospital of W…·Nectin4-positive Advanced Malignan…
1 trials
Overview
Program
Padcev (enfortumab vedotin)CAR-T therapy for nectin4-positive malignant solid tumor
Overview
Company
Astellas / Pfizer (Seagen)The Sixth Affiliated Hospital of Wenzhou Medical University
Overview
Modality
ADCCGT
Overview
Target
Nectin-4Nectin4-positive Advanced Malignant Soli
Overview
Indication
Locally advanced or metastatic urothelial carcinomaNectin4-positive Advanced Malignant Solid Tumor
Overview
Phase
APPROVEDPHASE_1
Overview
Status
APPROVEDACTIVE
Overview
Content status
Curated CoreLimited Data
Overview
Data Confidence
Data Confidence · HighData Confidence · Low
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · Watch
Overview
Approval status
FDA approvedInvestigational
Positioning
Key differentiator
Nectin-4 is near-uniformly expressed in urothelial carcinoma, giving an unusually clean tumor-selective target in that tissue.
Positioning
Known limitation
Nectin-4 loss, MMAE efflux, and tubulin alterations.
Positioning
Development positioning
1L standard of care in urothelial carcinoma with pembrolizumab.
Technology
Payload
MMAE (monomethyl auristatin E, tubulin inhibitor)
Technology
Linker
Protease-cleavable mc-vc-PAB, DAR ~3.8
Technology
DAR
DAR 3.8
MoA
Mechanism
Binds Nectin-4 on urothelial tumor cells, internalizes, and releases MMAE after cathepsin B cleavage; microtubule disruption arrests mitosis and triggers apoptosis.
MoA
Biomarker
Nectin-4 expression is high in urothelial carcinoma; no companion diagnostic required.
PK/PD
Half-life
ADC ~3.4 days; free MMAE ~2.4 days
PK/PD
Species
Cynomolgus monkey, ORR, PFS, OS
PK/PD
Animal (cat.)
Human, NHP, In vitro
PK/PD
Experiment
Pharmacokinetic
Toxicology
Species
Cynomolgus monkey, Mouse, Rat
Toxicology
Major finding
Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring.
Toxicology
CRS
N/A
Clinical
Safety signal
Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring.
Clinical
Selected reported efficacy
ORR 67.7%
Clinical
Reported ORR
67.7% (EV + pembrolizumab)
Clinical
Reported PFS
12.5 mo vs 6.3 mo (chemo)
Clinical
Reported OS
31.5 mo vs 16.1 mo (chemo)
Clinical
Result source
EV-302 / KEYNOTE-A39 (NCT04223856)
Clinical
Program phase
APPROVEDPHASE_1
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT04223856
Preclinical
Animal (cat.)
Human, Mouse, In vitro