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

Last updated: August 20, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

1/2

Condition

Gastric Cancer

Digestive System Neoplasms

Stomach Cancer

Treatment

Bemarituzumab

SOX

Nivolumab

Clinical Study ID

NCT05322577
20210099
  • Ages 18-100
  • All Genders

Study 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.

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

Total Participants: 70
Treatment Group(s): 4
Primary Treatment: Bemarituzumab
Phase: 1/2
Study Start date:
May 17, 2022
Estimated Completion Date:
August 15, 2028

Connect with a study center

  • Fujita Health University Hospital

    Toyoake-shi, Aichi 470-1192
    Japan

    Active - Recruiting

  • Hirosaki University Hospital

    Hirosaki-shi, Aomori 036-8563
    Japan

    Active - Recruiting

  • Chiba University Hospital

    Chiba-shi, Chiba 260-8677
    Japan

    Active - Recruiting

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama-shi, Ehime 791-0280
    Japan

    Active - Recruiting

  • Fukui Prefectural Hospital

    Fukui-Shi, Fukui 910-8526
    Japan

    Active - Recruiting

  • Kyushu University Hospital

    Fukuoka-shi, Fukuoka 812-8582
    Japan

    Active - Recruiting

  • Fukushima Medical University Hospital

    Fukushima-shi, Fukushima 960-1295
    Japan

    Active - Recruiting

  • Gifu University Hospital

    Gifu-shi, Gifu 501-1194
    Japan

    Active - Recruiting

  • Ogaki Municipal Hospital

    Ogaki-shi, Gifu 503-8502
    Japan

    Terminated

  • Gunma University Hospital

    Maebashi-shi, Gunma 371-8511
    Japan

    Active - Recruiting

  • Gunma Prefectural Cancer Center

    Ota-shi, Gunma 373-8550
    Japan

    Active - Recruiting

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima-shi, Hiroshima 730-8518
    Japan

    Active - Recruiting

  • Hiroshima University Hospital

    Hiroshima-shi, Hiroshima 734-8551
    Japan

    Active - Recruiting

  • Ibaraki Prefectural Central Hospital

    Kasama-shi, Ibaraki 309-1793
    Japan

    Active - Recruiting

  • Ishikawa Prefectural Central Hospital

    Kanazawa-shi, Ishikawa 920-8530
    Japan

    Active - Recruiting

  • Kagawa University Hospital

    Kita-gun, Kagawa 761-0793
    Japan

    Active - Recruiting

  • St Marianna University Hospital

    Kawasaki-shi, Kanagawa 216-8511
    Japan

    Active - Recruiting

  • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

    Yokohama-shi, Kanagawa 241-8515
    Japan

    Active - Recruiting

  • Kochi Health Sciences Center

    Kochi-shi, Kochi 781-8555
    Japan

    Active - Recruiting

  • Kyoto University Hospital

    Kyoto-shi, Kyoto 606-8507
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai-shi, Miyagi 980-8574
    Japan

    Active - Recruiting

  • Okayama University Hospital

    Okayama-shi, Okayama 700-8558
    Japan

    Active - Recruiting

  • Osaka General Medical Center

    Osaka-shi, Osaka 558-8558
    Japan

    Active - Recruiting

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki-shi, Osaka 569-8686
    Japan

    Active - Recruiting

  • Shizuoka General Hospital

    Shizuoka-shi, Shizuoka 420-8527
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka 411-8777
    Japan

    Active - Recruiting

  • Dokkyo Medical University Hospital

    Shimotsuga-gun, Tochigi 321-0293
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo 104-0045
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo 135-8550
    Japan

    Active - Recruiting

  • IMSUT Hospital, The Institute of Medical Science The University of Tokyo

    Minato-ku, Tokyo 108-8639
    Japan

    Active - Recruiting

  • Toyama University Hospital

    Toyama-shi, Toyama 930-0194
    Japan

    Active - Recruiting

  • National Cancer Center

    Goyang-si Gyeonggi-do, 10408
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Korea University Guro Hospital

    Seoul, 08308
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • National University Hospital

    Singapore, 119074
    Singapore

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • Northport Veterans Affairs Medical Center

    Northport, New York 11768
    United States

    Terminated

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