This is a multicenter, open-label, uncontrolled, phase I study to evaluate the tolerability, safety, pharmacokinetics, and efficacy of ONO-4538HSC administered subcutaneously in participants with advanced or metastatic solid tumors. This study consists of the tolerability confirmation part to determine the recommended dose for Japanese participants by evaluating the DLTs and the expansion part to evaluate the safety and pharmacokinetics and to explore the efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
ONO-4538HSC will be administered subcutaneously once every 4 weeks.
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
Dose-limiting toxicities (DLT)
Time frame: 28 days
Adverse event (AE)
Time frame: UP to 100 days after the last dose
Pharmacokinetics(serum concentration of Nivolumab)
Time frame: Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)
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Kindai University Hospital
Osakasayama-shi, Osaka, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital Of JFCR
Koto-ku, Tokyo, Japan