This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of DS-1123a in Japanese subjects with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
starting intravenous (IV) dose of 0.1 mg/kg.
Unnamed facility
Tokyo, Japan
Maximum concentration (Cmax)
Time frame: Cycles 1, 2 : Days 1,2, 4, 8, 15
Number and severity of treatment emergent adverse events (TEAEs)
Time frame: Day 1 to Day 31
Time of maximum concentration (Tmax)
Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15
Elimination rate constant (Kel)
Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15
area under the curve AUClast
pharmacokinetics profile
Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15
Area under the curve (AUCtau)
Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15
Area under the curve (AUCinf)
Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15
Half-life (T1/2)
Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15
Drug clearance (CL)
Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15
Volume of distribution (Vz)
Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15
Mean residence time (MRTinf)
Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15
DS-1123a antibody
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
DS-1123a antibody on Cycle 1: Days 1,15; Cycles 2 and on: Day 1, Stop date, final follow-up date
Time frame: Cycle 1: Days 1,15; Cycles 2: Day 1; Stop date, final follow-up date
Change in Cytokines expression
Change in DS-1123a biomarkers Cytokines expression on Cycle 1: Days 1, 2, 15, 16; Cycle 2: Days 1, 2
Time frame: Cycle 1: Days 1, 2, 15, 16; Cycle 2: Days 1, 2