The main objectives of this study are to evaluate the safety and tolerability of bemarituzumab in combination with other anti-cancer therapies, and to evaluate the efficacy of bemarituzumab in combination with S-1 and oxaliplatin (SOX) and nivolumab as assessed by objective response.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
72
Intravenous (IV) infusion
CAPOX administered as a combination of oxaliplatin as an IV infusion and capecitabine orally as tablets.
SOX administered as a combination of oxaliplatin as an IV infusion and S-1 orally.
Part 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
Time frame: Day 1 up to Day 21
Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1 to end of treatment (up to approximately 1 year)
Part 2: Objective Response (OR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: Up to 30 Months
Part 1: Area Under the Concentration-time Curve (AUC) of Bemarituzumab
Time frame: Day 1 to end of treatment (up to approximately 1 year)
Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab
Time frame: Day 1 to end of treatment (up to approximately 1 year))
Part 1: Observed Concentration at the end of a Dose Interval (Ctrough) of Bemarituzumab
Time frame: Day 1 to end of treatment (up to approximately 1 year)
Part 1: OR per RECIST v1.1
Time frame: Up to 2 years
Part 1: Duration of Response (DoR) per RECIST v1.1
Time frame: Up to 2 years
Part 1: Disease Control Rate (DCR)
Time frame: Up to 2 years
Part 1: Progression-free Survival (PFS) per RECIST v1.1
Time frame: Up to 2 years
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IV infusion.
Northport Veterans Affairs Medical Center
Northport, New York, United States
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, Japan
Hirosaki University Hospital
Hirosaki-shi, Aomori, Japan
Chiba University Hospital
Chiba, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
Fukui Prefectural Hospital
Fukui-shi, Fukui, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Gifu University Hospital
Gifu, Gifu, Japan
Ogaki Municipal Hospital
Ogaki-shi, Gifu, Japan
...and 32 more locations
Part 1: Overall Survival (OS)
Time frame: Up to 2 years
Part 2: Number of Participants Who Experience TEAEs
Time frame: Up to 30 months
Part 2: DoR per RECIST v1.1
Time frame: Up to 30 months
Part 2: Time to Response (TTR) per RECIST v1.1
Time frame: Up to 30 months
Part 2: Disease Control (DC) per RECIST v1.1
Time frame: Up to 30 months
Part 2: PFS per RECIST v1.1
Time frame: Up to 30 months
Part 2: OS
Time frame: Up to 30 months