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항목
ADCStandard DatabasestalePhase 3
T-DM1 (Trastuzumab emtansine, Trastuzumab emtansine (T-DM1))
Roche / Genentech·HER2
59 trials·t½ 4 h
Overview
Program
Trastuzumab emtansine (T-DM1)
Overview
Company
Roche / Genentech
Overview
Modality
ADC
Overview
Target
HER2
Overview
Indication
Unrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer Participants
Overview
Phase
PHASE_3
Overview
Status
RECRUITING
Overview
Content status
Standard Database
Overview
Data Confidence
Data Confidence · Medium
Overview
Development Signal
Development Signal · Emerging
Overview
Approval status
Investigational
Technology
Payload
DM1 via butelase-1 with ABD fusion for pote
Technology
Linker
cleavable peptide linker and a topoisomerase I payload with byst
MoA
Mechanism
targeting human epidermal growth factor receptor
MoA
Biomarker
HER2-positive
PK/PD
Half-life
4 h
PK/PD
Species
Mouse
PK/PD
Animal (cat.)
Mouse, In vitro
PK/PD
Experiment
tumor growth inhibition
Toxicology
Species
Mouse
Toxicology
Animal (cat.)
Mouse, In vitro
Toxicology
Major finding
Interstitial lung disease was observed for both agents
Clinical
Safety signal
Interstitial lung disease was observed for both agents
Clinical
Selected reported efficacy
ORR 69.7%
Clinical
Reported ORR
69.7%
Clinical
Reported PFS
17.8
Clinical
Reported OS
39.2
Clinical
Result source
ClinicalTrials.gov NCT03523585
Clinical
Program phase
PHASE_3
Clinical
Trial ref
NCT03523585