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API CSV32행 · 1개 프로그램

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항목
AntibodyCurated CorestalePhase 2
Cemiplimab (Cemiplimab)
Regeneron / Sanofi·Solid Tumor
123 trials·t½ 22 h
Overview
Program
Cemiplimab
Overview
Company
Regeneron / Sanofi
Overview
Modality
ANTIBODY
Overview
Target
Solid Tumor
Overview
Indication
Breast Neoplasms; Breast Cancer
Overview
Phase
PHASE_2
Overview
Status
RECRUITING
Overview
Content status
Curated Core
Overview
Data Confidence
Data Confidence · High
Overview
Development Signal
Development Signal · Emerging
Overview
Approval status
Investigational
Positioning
Key differentiator
unique and favorable safety profile with no reported grade 4 or 5 immune-related adverse events after more than 2 years of fol
Positioning
Known limitation
resistance to immune checkpoint blockade
MoA
Mechanism
, clinical trial data, and its role compared to other PD-1/PD-L1 inhibitors, such as pembrolizumab and cemiplimab
MoA
Biomarker
biomarker-driven phase II platform trial evaluating cemiplimab-based immunotherapy in microsatellite-stable c
PK/PD
Half-life
22 h
PK/PD
Species
Cynomolgus monkey
PK/PD
Animal (cat.)
NHP, Monkey
PK/PD
Experiment
pharmacokinetic
Toxicology
Species
Cynomolgus monkey
Toxicology
Animal (cat.)
NHP, Monkey
Toxicology
Major finding
thrombocytopenia and one of Grade 2 cytokine release syndrome, while Cohort B had one case of &#
Toxicology
CRS
Reported
Clinical
Safety signal
thrombocytopenia and one of Grade 2 cytokine release syndrome, while Cohort B had one case of &#
Clinical
Selected reported efficacy
ORR 52%
Clinical
Reported ORR
52%
Clinical
Reported PFS
2.8
Clinical
Reported OS
11.7
Clinical
Result source
ClinicalTrials.gov NCT03257267
Clinical
Program phase
PHASE_2
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT03257267