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항목
AntibodyLimited DatastalePhase 3
H1 receptor antagonist (H1 receptor antagonist)
Merck Sharp & Dohme LLC·Lung Neoplasm Malignant
31 trials
Overview
Program
H1 receptor antagonist
Overview
Company
Merck Sharp & Dohme LLC
Overview
Modality
ANTIBODY
Overview
Target
Lung Neoplasm Malignant
Overview
Indication
Ovarian Cancer; Fallopian Tube Cancer
Overview
Phase
PHASE_3
Overview
Status
RECRUITING
Overview
Content status
Limited Data
Overview
Data Confidence
Data Confidence · Low
Overview
Development Signal
Development Signal · Emerging
Overview
Approval status
Investigational
MoA
Mechanism
inhibits glioblastoma cell growth primarily through G 1 arrest and cytoskeletal remodeling, with minimal contribution from classical cell death pathway
MoA
Biomarker
PD-1/PD-L1 resistance in oncogenic driver mutation-positive
PK/PD
Species
Mouse, precluding FDA approval.
PK/PD
Animal (cat.)
Mouse
PK/PD
Experiment
pharmacokinetic
Toxicology
Species
Mouse, precluding FDA approval.
Toxicology
Animal (cat.)
Mouse
Toxicology
Major finding
hepatotoxicity and limited efficacy, precluding FDA approval
Clinical
Safety signal
hepatotoxicity and limited efficacy, precluding FDA approval
Clinical
Selected reported efficacy
ORR 6%
Clinical
Reported ORR
6%
Clinical
Reported PFS
4.7
Clinical
Reported OS
11.2
Clinical
Result source
ClinicalTrials.gov NCT00332163
Clinical
Program phase
PHASE_3
Clinical
Trial ref
NCT00332163
Preclinical
Animal (cat.)
Mouse