Phase
Condition
Gastric Cancer
Stomach Cancer
Digestive System Neoplasms
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-ken 1865694 470-1192
JapanSite Not Available
Hirosaki University Hospital
Hirosaki-shi, Aomori 2130656 036-8563
JapanSite Not Available
Chiba University Hospital
Chiba-shi, Chiba 260-8677
JapanSite Not Available
Chiba University Hospital
Chiba 2113015, Chiba 2113014 260-8677
JapanSite Not Available
National Hospital Organization Shikoku Cancer Center
Matsuyama-shi, Ehime 791-0280
JapanSite Not Available
National Hospital Organization Shikoku Cancer Center
Matsuyama 1926099, Ehime 1864226 791-0280
JapanSite Not Available
Fukui Prefectural Hospital
Fukui-Shi, Fukui 910-8526
JapanSite Not Available
Fukui Prefectural Hospital
Fukui-shi 1863985, Fukui 1863983 910-8526
JapanSite Not Available
Kyushu University Hospital
Fukuoka-shi, Fukuoka 812-8582
JapanSite Not Available
Kyushu University Hospital
Fukuoka 1863967, Fukuoka 1863958 812-8582
JapanSite Not Available
Fukushima Medical University Hospital
Fukushima-shi, Fukushima 960-1295
JapanSite Not Available
Fukushima Medical University Hospital
Fukushima 2112923, Fukushima 2112922 960-1295
JapanSite Not Available
Gifu University Hospital
Gifu-shi, Gifu 501-1194
JapanSite Not Available
Gifu University Hospital
Gifu 1863641, Gifu 1863640 501-1194
JapanSite Not Available
Ogaki Municipal Hospital
Ogaki-shi, Gifu 1863640 503-8502
JapanSite Not Available
Gunma University Hospital
Maebashi-shi, Gunma 371-8511
JapanSite Not Available
Gunma University Hospital
Maebashi 1857843, Gunma 1863501 371-8511
JapanSite Not Available
Gunma Prefectural Cancer Center
Ota-shi, Gunma 1863501 373-8550
JapanSite Not Available
Hiroshima City Hiroshima Citizens Hospital
Hiroshima-shi, Hiroshima 730-8518
JapanSite Not Available
Hiroshima University Hospital
Hiroshima-shi, Hiroshima 734-8551
JapanActive - Recruiting
Hiroshima City Hiroshima Citizens Hospital
Hiroshima 1862415, Hiroshima 1862413 730-8518
JapanSite Not Available
Hiroshima University Hospital
Hiroshima 1862415, Hiroshima 1862413 734-8551
JapanSite Not Available
Ibaraki Prefectural Central Hospital
Kasama-shi, Ibaraki 2112669 309-1793
JapanSite Not Available
Ishikawa Prefectural Central Hospital
Kanazawa-shi, Ishikawa 920-8530
JapanSite Not Available
Ishikawa Prefectural Central Hospital
Kanazawa 1860243, Ishikawa-ken 1861387 920-8530
JapanSite Not Available
Kagawa University Hospital
Kita-gun, Kagawa-ken 1860834 761-0793
JapanSite Not Available
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama-shi, Kanagawa 241-8515
JapanSite Not Available
St Marianna University Hospital
Kawasaki-shi, Kanagawa 1860291 216-8511
JapanSite Not Available
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama 1848354, Kanagawa 1860291 241-8515
JapanSite Not Available
Kochi Health Sciences Center
Kochi-shi, Kochi 781-8555
JapanSite Not Available
Kochi Health Sciences Center
Kochi 1859146, Kochi 1859133 781-8555
JapanSite Not Available
Kyoto University Hospital
Kyoto-shi, Kyoto 606-8507
JapanSite Not Available
Kyoto University Hospital
Kyoto 1857910, Kyoto 1857907 606-8507
JapanSite Not Available
Tohoku University Hospital
Sendai-shi, Miyagi 980-8574
JapanSite Not Available
Tohoku University Hospital
Sendai 2111149, Miyagi 2111888 980-8574
JapanSite Not Available
Okayama University Hospital
Okayama-shi, Okayama 700-8558
JapanSite Not Available
Okayama University Hospital
Okayama 1854383, Okayama-ken 1854381 700-8558
JapanSite Not Available
Osaka General Medical Center
Osaka-shi, Osaka 558-8558
JapanSite Not Available
Osaka General Medical Center
Osaka 1853909, Osaka 1853904 558-8558
JapanSite Not Available
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-shi, Osaka 1853904 569-8686
JapanSite Not Available
Shizuoka General Hospital
Shizuoka-shi, Shizuoka 420-8527
JapanSite Not Available
Shizuoka General Hospital
Shizuoka 1851717, Shizuoka 1851715 420-8527
JapanSite Not Available
Shizuoka Cancer Center
Sunto-gun, Shizuoka 1851715 411-8777
JapanSite Not Available
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi 1850310 321-0293
JapanSite Not Available
National Cancer Center Hospital
Chuo-ku, Tokyo 1850144 104-0045
JapanSite Not Available
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo 1850144 135-8550
JapanSite Not Available
IMSUT Hospital, The Institute of Medical Science The University of Tokyo
Minato-ku, Tokyo 1850144 108-8639
JapanSite Not Available
Toyama University Hospital
Toyama-shi, Toyama 930-0194
JapanSite Not Available
Toyama University Hospital
Toyama 1849876, Toyama 1849872 930-0194
JapanSite Not Available
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 ofSite Not Available
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
SingaporeSite Not Available
National University Hospital
Singapore 1880252, 119074
SingaporeSite Not Available
National Cancer Center
Goyang-si Gyeonggi-do, 10408
South KoreaSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
South KoreaSite Not Available
Asan Medical Center
Seoul 1835848, 05505
South KoreaSite Not Available
Korea University Guro Hospital
Seoul 1835848, 08308
South KoreaSite Not Available
Samsung Medical Center
Seoul 1835848, 06351
South KoreaSite Not Available
Seoul National University Hospital
Seoul 1835848, 03080
South KoreaSite Not Available
Severance Hospital Yonsei University Health System
Seoul 1835848, 03722
South KoreaSite Not Available
National Taiwan University Hospital
Taipei, 10002
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei, 11217
TaiwanSite Not Available
National Taiwan University Hospital
Taipei 1668341, 10002
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei 1668341, 11217
TaiwanSite Not Available
Northport Veterans Affairs Medical Center
Northport, New York 11768
United StatesSite Not Available
Northport Veterans Affairs Medical Center
Northport 5129290, New York 5128638 11768
United StatesSite Not Available

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