This is an open label, dose escalation phase I study to evaluate the clinical safety, tolerability in subjects with advanced solid tumors, and to establish the Maximum Tolerated Dose (MTD#, if any). This study is composed of two dose level: 1 and 3 mg/kg.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
The dose levels will be escalated following a modified 3+3 dose escalation scheme.
Henan Cancer Hospital
Zhengzhou, Henan, China
safety and tolerability
Number of participants with adverse events
Time frame: From the day of first dose to 21 days after last dose
area under the curve
(AUC)0-21d
Time frame: From the time of infusion to 21 days after first dose and forth dose
maximum observed serum concentration (Cmax)
Time frame: From the time of infusion to 21 days after first dose and forth dose
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