Phase
Condition
Gastric Cancer
Digestive System Neoplasms
Stomach Cancer
Treatment
Bemarituzumab
SOX
Nivolumab
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults with unresectable, locally advanced or metastatic gastric or gastroesophagealjunction cancer not amendable to curative therapy.
Ability to provide tumor sample, either archival (obtained within 6 months tojoining study) or fresh biopsy.
For certain arms for Part 1, FGFR2b overexpression positive defined as any FGFR2b 2+/3+ TC determined by centrally performed immunohistochemistry (IHC), based ontumor sample provided.
For Part 2, FGFR2b overexpression positive defined as FGFR2b ≥10% 2+/3+ TCdetermined by centrally performed IHC testing, based on tumor sample provided.
Easter Cooperative Oncology Group (ECOG) performance score less than or equal to 1.
Measurable or non-measurable disease as long as evaluable by Response EvaluationCriteria Solid Tumors (RECIST) version 1.1
Participant has no contradictions to CAPOX/SOX plus or minus nivolumab.
Adequate organ function.
For Part 2, measurable disease according to RECIST v1.1.
Exclusion
Exclusion Criteria:
Prior treatment for metastatic or unresectable disease (Note: prior adjuvant orneo-adjuvant therapy for local disease is allowed if ended more than 6 months of 1stdose).
Prior treatment with any selective inhibitor of fibroblast growth factor -fibroblast growth factor receptor (FGF-FGFR) pathway.
Known human epidermal growth factor receptor 2 (HER2) positive
Untreated or symptomatic central nervous system (CNS) disease or brain metastases.
Peripheral sensory neuropathy greater than or equal to Grade 2.
Clinically significant cardiac disease.
Other malignancy within the last 2 years (exceptions for definitively treateddisease).
Chronic or systemic ophthalmological disorders.
Major surgery or other investigational study within 28 days of first study treatmentdose.
Palliative radiotherapy within 14 days of first study treatment dose.
Abnormalities of the cornea that may pose an increased risk of developing a cornealulcer.
History or evidence of systemic disease or ophthalmological disorders requiringchronic use of ophthalmic corticosteroids.
Study Design
Connect with a study center
Fujita Health University Hospital
Toyoake-shi, Aichi 470-1192
JapanActive - Recruiting
Hirosaki University Hospital
Hirosaki-shi, Aomori 036-8563
JapanActive - Recruiting
Chiba University Hospital
Chiba-shi, Chiba 260-8677
JapanActive - Recruiting
National Hospital Organization Shikoku Cancer Center
Matsuyama-shi, Ehime 791-0280
JapanActive - Recruiting
Fukui Prefectural Hospital
Fukui-Shi, Fukui 910-8526
JapanActive - Recruiting
Kyushu University Hospital
Fukuoka-shi, Fukuoka 812-8582
JapanActive - Recruiting
Fukushima Medical University Hospital
Fukushima-shi, Fukushima 960-1295
JapanActive - Recruiting
Gifu University Hospital
Gifu-shi, Gifu 501-1194
JapanActive - Recruiting
Ogaki Municipal Hospital
Ogaki-shi, Gifu 503-8502
JapanTerminated
Gunma University Hospital
Maebashi-shi, Gunma 371-8511
JapanActive - Recruiting
Gunma Prefectural Cancer Center
Ota-shi, Gunma 373-8550
JapanActive - Recruiting
Hiroshima City Hiroshima Citizens Hospital
Hiroshima-shi, Hiroshima 730-8518
JapanActive - Recruiting
Hiroshima University Hospital
Hiroshima-shi, Hiroshima 734-8551
JapanActive - Recruiting
Ibaraki Prefectural Central Hospital
Kasama-shi, Ibaraki 309-1793
JapanActive - Recruiting
Ishikawa Prefectural Central Hospital
Kanazawa-shi, Ishikawa 920-8530
JapanActive - Recruiting
Kagawa University Hospital
Kita-gun, Kagawa 761-0793
JapanActive - Recruiting
St Marianna University Hospital
Kawasaki-shi, Kanagawa 216-8511
JapanActive - Recruiting
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama-shi, Kanagawa 241-8515
JapanActive - Recruiting
Kochi Health Sciences Center
Kochi-shi, Kochi 781-8555
JapanActive - Recruiting
Kyoto University Hospital
Kyoto-shi, Kyoto 606-8507
JapanActive - Recruiting
Tohoku University Hospital
Sendai-shi, Miyagi 980-8574
JapanActive - Recruiting
Okayama University Hospital
Okayama-shi, Okayama 700-8558
JapanActive - Recruiting
Osaka General Medical Center
Osaka-shi, Osaka 558-8558
JapanActive - Recruiting
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-shi, Osaka 569-8686
JapanActive - Recruiting
Shizuoka General Hospital
Shizuoka-shi, Shizuoka 420-8527
JapanActive - Recruiting
Shizuoka Cancer Center
Sunto-gun, Shizuoka 411-8777
JapanActive - Recruiting
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi 321-0293
JapanActive - Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo 104-0045
JapanActive - Recruiting
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo 135-8550
JapanActive - Recruiting
IMSUT Hospital, The Institute of Medical Science The University of Tokyo
Minato-ku, Tokyo 108-8639
JapanActive - Recruiting
Toyama University Hospital
Toyama-shi, Toyama 930-0194
JapanActive - Recruiting
National Cancer Center
Goyang-si Gyeonggi-do, 10408
Korea, Republic ofActive - Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Korea University Guro Hospital
Seoul, 08308
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
Severance Hospital Yonsei University Health System
Seoul, 03722
Korea, Republic ofActive - Recruiting
National University Hospital
Singapore, 119074
SingaporeActive - Recruiting
National Taiwan University Hospital
Taipei, 10002
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei, 11217
TaiwanActive - Recruiting
Northport Veterans Affairs Medical Center
Northport, New York 11768
United StatesTerminated
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