The purpose of this study is to assess the safety and tolerability of NTKR-214 in combination with nivolumab in Japanese participants with advanced malignant tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Local Institution
Chuo-ku, Tokyo, Japan
Incidence of adverse events (AEs)
Time frame: Approximately 2 years
Incidence of serious adverse events (SAEs)
Time frame: Approximately 2 years
Incidence of AEs leading to discontinuation
Time frame: Approximately 2 years
Incidence of deaths
Time frame: Approximately 2 years
Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
Time frame: Approximately 2 years
Incidence of laboratory abnormalities
Time frame: Approximately 2 years
Maximum observed concentration (Cmax)
Time frame: Approximately 2 years
Time of maximum observed concentration (Tmax)
Time frame: Approximately 2 years
Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame: Approximately 2 years
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame: Approximately 2 years
Total body clearance (CLT)
Time frame: Approximately 2 years
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Volume of distribution (Vz)
Time frame: Approximately 2 years
Apparent terminal phase half-life (T-HALF)
Time frame: Approximately 2 years
Trough observed serum concentration at the end of the dosing interval (Ctrough)
Time frame: Approximately 2 years
Incidence of anti-drug antibodies (ADA) to NKTR-214
Time frame: Approximately 2 years
Incidence of anti-drug antibodies (ADA) to nivolumab
Time frame: Approximately 2 years
Best overall response (BOR)
Time frame: Approximately 2 years
Duration of response (DOR)
Time frame: Approximately 2 years