The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and maximum tolerated dose (MTD) of YYB101, HGF-neutralizing humanized Mab, in advanced solid tumors patients who are refractory to standard therapy.
To evaluate the safety, tolerability, and pharmacokinetics of YYB101, patients who are refractory to standard therapy will be enrolled in this study. In dose-escalation cohort, subjects will be enrolled sequentially into four dose cohorts receiving a single dose of YYB101 (0.3, 1, 3, or 5 mg/kg; 3 or 6 subjects per dose cohort) and will be entered the 4-week treatment-free period to evaluate safety and pharmacokinetics. If no dose-limiting toxicity (DLT) is observed during the 4-week period, YYB101 administration will be resumed at the same dose level every 2 weeks until disease progression or unacceptable toxicity development. After the completion of the dose-escalation cohort, additional subjects will be enrolled into a dose-expansion cohort at the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) for further exploration of safety, tolerability, efficacy and pharmacodynamics.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Dose-escalation cohort: YYB101 of each dose level (0.3mg/kg to 5mg/kg), IV infusion on Day 1, Day 29, and followed by every 2 weeks until disease progression or unacceptable toxicity development. Dose-expansion cohort: YYB101 of MTD (or RP2D), IV infusion every 2 weeks until disease progression or unacceptable toxicity development
Samsung Medical Center
Seoul, South Korea
Dose-escalation cohort: DLTs and MTD
Time frame: 28 days
Incidence of AEs that result in discontinuation and dose reduction of YYB101
Time frame: By 12 months after enrollment of the last subject
Clinical laboratory abnormalities that result in discontinuation and dose reduction of YYB101
Time frame: By 12 months after enrollment of the last subject
Vital sign that result in discontinuation and dose reduction of YYB101
Time frame: By 12 months after enrollment of the last subject
Anti-YYB101 antibody that result in discontinuation and dose reduction of YYB101
Time frame: By 12 months after enrollment of the last subject
Area under the plasma concentration versus time curve (AUC) of YYB101
Time frame: By 4 and 8 weeks after last administration, average 16 weeks
Peak Plasma Concentration (Cmax) of YYB101
Time frame: By 4 and 8 weeks after last administration, average 16 weeks
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