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A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.
Sponsor: Amgen
Summary
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.
Official title: A Phase 1b/2 Study Evaluating the Safety, Tolerability, Efficacy, and Pharmacokinetics of Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer (FORTITUDE-103).
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2022-05-17
Completion Date
2026-08-12
Last Updated
2025-12-05
Healthy Volunteers
No
Interventions
Bemarituzumab
Intravenous (IV) infusion
CAPOX
CAPOX administered as a combination of oxaliplatin as an IV infusion and capecitabine orally as tablets.
SOX
SOX administered as a combination of oxaliplatin as an IV infusion and S-1 orally.
Nivolumab
IV infusion.
Locations (42)
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
Gunma University Hospital
Maebashi, Gunma, Japan
Gunma Prefectural Cancer Center
Ota-shi, Gunma, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Hiroshima, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Ibaraki Prefectural Central Hospital
Kasama-shi, Ibaraki, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
St Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Kochi Health Sciences Center
Kochi, Kochi, Japan
Kyoto University Hospital
Kyoto, Kyoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Osaka General Medical Center
Osaka, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-shi, Osaka, Japan
Shizuoka General Hospital
Shizuoka, Shizuoka, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan
IMSUT Hospital, The Institute of Medical Science The University of Tokyo
Minato-ku, Tokyo, Japan
Toyama University Hospital
Toyama, Toyama, Japan
National University Hospital
Singapore, Singapore
National Cancer Center
Goyang-si Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan