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ACTIVE NOT RECRUITING
NCT05322577
PHASE1/PHASE2

A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.

Sponsor: Amgen

View on ClinicalTrials.gov

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

DRUG

Bemarituzumab

Intravenous (IV) infusion

DRUG

CAPOX

CAPOX administered as a combination of oxaliplatin as an IV infusion and capecitabine orally as tablets.

DRUG

SOX

SOX administered as a combination of oxaliplatin as an IV infusion and S-1 orally.

DRUG

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