The purpose of this study is to evaluate safety and pharmacokinetics as well as the biodistribution of OTSA101-DTPA-111In and to evaluate the safety of intravenous administration of OTSA101-DTPA-90Y.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
single IV injection, 185MBq/body
IV injection (max. 3 injections per patient), 1110MBq/body
Osaka International Cancer Institute
Osaka, Japan
Cancer Institute Hospital of JFCR
Tokyo, Japan
National Cancer Center Hospital
Tokyo, Japan
Pharmacokinetic (PK) and Biodistribution of OTSA101-DTPA-111In
Concentration of OTSA101-DTPA in plasma and the distribution of OTSA101-DTPA in the body by imaging scan will be assessed.
Time frame: up to 72 hours post dosing
Safety of OTSA101-DTPA-111In
This outcome will be evaluated via overall listing of Treatment-Emergent Adverse Events and the incidence of each Treatment-Emergent Adverse Event that meets DLT criteria.
Time frame: up to 10 days post dosing
Safety of OTSA101-DTPA-90Y
This outcome will be evaluated via overall listing of Treatment-Emergent Adverse Events and the incidence of each Treatment-Emergent Adverse Event that meets DLT criteria.
Time frame: up to 6 weeks post dosing
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