This study is to evaluate the tolerability and safety of ONO-7428 in participants with unresectable advanced or recurrent solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Specified dose on specified days
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
RECRUITINGNational Cancer Center Hospital East
Kashiwa, Chiba, Japan
Dose-limiting toxicities(DLT)
Time frame: 21 days
Adverse event (AE)
Time frame: Up to 2 years
Cmax
Time frame: Up to 2 years
Tmax
Time frame: Up to 2 years
Area under the Plasma Concentration versus Time Curve (AUC)
Time frame: Up to 2 years
Ctrough
Time frame: Up to 2 years
Objective Response Rate (ORR)
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Progression-Free Survival (PFS)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Time to Response (TTR)
Time frame: Up to 2 years
Best Overall Response (BOR)
Time frame: Up to 2 years
North America Clinical Trial Support Desk
CONTACT
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Kurume University Hospital
Kurume, Fukuoka, Japan
RECRUITINGHyogo Medical University Hospital
Nishinomiya, Hyōgo, Japan
RECRUITINGKitasato University Hospital
Sagamihara, Kanagawa, Japan
RECRUITINGKanagawa Cancer Center
Yokohama, Kanagawa, Japan
RECRUITINGKochi Medical School Hospital
Nankoku, Kochi, Japan
RECRUITINGKyoto University Hospital
Kyoto, Kyoto, Japan
RECRUITINGKansai Medical University Hospital
Hirakata, Osaka, Japan
RECRUITINGOsaka International Cancer Institute
Osaka, Osaka, Japan
RECRUITING...and 5 more locations
Percent change from baseline in the sum of diameters of target lesions
Time frame: Up to 2 years
Best reduction percent change from baseline in the sum of diameters of target lesions
Time frame: Up to 2 years