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항목
ADCStandard DatabasestalePhase 3
Inotuzumab ozogamicin (Inotuzumab ozogamicin)
Pfizer·Precursor Cell Lymphoblastic Leuke…
53 trials·t½ 12.3 h
Overview
Program
Inotuzumab ozogamicin
Overview
Company
Pfizer
Overview
Modality
ADC
Overview
Target
Precursor Cell Lymphoblastic Leukemia-Ly
Overview
Indication
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative; Recurrent B Acute Lymphoblastic Leukemia
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
Linker
linker, or payload that have limited their development
MoA
Mechanism
targeting specific cell surface antigens, many ADCs have also been associated with unique toxicities related to the antigen
MoA
Biomarker
CD19 expression, whereas cytoplasmic CD22 expression
PK/PD
Half-life
12.3 h
PK/PD
Species
Mouse
PK/PD
Animal (cat.)
Mouse, In vitro
PK/PD
Experiment
Pharmacokinetic
Toxicology
Species
Mouse
Toxicology
Animal (cat.)
Mouse, In vitro
Toxicology
Major finding
thrombocytopenia (31 patients [84%]), being the most common
Toxicology
CRS
Reported
Clinical
Safety signal
thrombocytopenia (31 patients [84%]), being the most common
Clinical
Reported PFS
5.0
Clinical
Reported OS
7.7
Clinical
Result source
ClinicalTrials.gov NCT01564784
Clinical
Program phase
PHASE_3
Clinical
Trial ref
NCT01564784