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항목
AntibodyCurated CoreFDAApproved
trastuzumab (Herceptin, Ogivri, Herzuma)
Roche / Genentech·HER2
1100 trials·t½ 4 h
Overview
Program
Herceptin (trastuzumab)
Overview
Company
Roche / Genentech
Overview
Modality
ANTIBODY
Overview
Target
HER2
Overview
Indication
HER2+ breast cancer, HER2+ gastric/GEJ 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
novel bifunctional chelator (2E-C-NETA) for applications in 177 Lu-based TRT
Positioning
Known limitation
resistance to trastuzumab-based targeted therapy and limited intratumoral antibody penetration continue to restrict clinical outcomes
MoA
Mechanism
Trastuzumab binds domain IV of HER2, inhibiting ligand-independent HER2 signaling, mediating ADCC via Fcγ receptors, and inducing internalization/degradation of HER2.
MoA
Biomarker
HER2 IHC 3+ or ISH amplified (ASCO/CAP guidelines).
PK/PD
Half-life
4 h
PK/PD
Species
Mouse, OS in metastatic BC
PK/PD
Animal (cat.)
Mouse, In vitro
PK/PD
Experiment
Pharmacokinetic
Toxicology
Species
Mouse, Rat
Toxicology
Major finding
Cardiotoxicity (LVEF decline, CHF risk especially with anthracyclines); infusion reactions; myelosuppression in combos.
Toxicology
CRS
N/A
Clinical
Safety signal
Cardiotoxicity (LVEF decline, CHF risk especially with anthracyclines); infusion reactions; myelosuppression in combos.
Clinical
Selected reported efficacy
ORR 91.2%
Clinical
Reported ORR
91.2%
Clinical
Result source
ClinicalTrials.gov NCT02149524
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT02149524