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Brief Title: A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.
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).
Study ID: NCT05322577
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Northport Veterans Affairs Medical Center, Northport, New York, United States
Ogaki Municipal Hospital, Ogaki-shi, Gifu, Japan
Gunma University Hospital, Maebashi-shi, Gunma, Japan
St Marianna University Hospital, Kawasaki-shi, Kanagawa, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan
Kochi Health Sciences Center, Kochi-shi, Kochi, Japan
Tohoku University Hospital, Sendai-shi, Miyagi, Japan
Okayama University Hospital, Okayama-shi, Okayama, Japan
Osaka General Medical Center, Osaka-shi, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital, Takatsuki-shi, Osaka, Japan
Shizuoka General Hospital, Shizuoka-shi, 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
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
National University Hospital, Singapore, , Singapore
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR