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New hope for stomach cancer: targeted drug combo enters human trials

NCT ID NCT05322577

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This study tests a new drug called bemarituzumab, given together with chemotherapy and an immunotherapy drug (nivolumab), in 72 adults with advanced stomach or gastroesophageal junction cancer that cannot be removed by surgery. The main goals are to check safety and see if the combination shrinks tumors. The trial is for people whose tumors have not been treated before and who have a specific protein (FGFR2b) on their cancer cells.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bemarituzumab (a targeted antibody) combined with chemotherapy (CAPOX or SOX) and the immunotherapy nivolumab
What this could lead to
If successful, this could lead to a new combination treatment option for people with advanced stomach or gastroesophageal junction cancer that has not been treated before.
What could go wrong
This is an early-phase trial with only 72 participants, so results may not apply to everyone. Side effects from combining multiple cancer drugs could be significant, and the treatment may not shrink tumors as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

72 people

The number who actually took part.

Started

May 2022

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amendable to curative therapy. * Ability to provide tumor sample, either archival (obtained within 6 months to joining 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 on tumor sample provided. * For Part 2, FGFR2b overexpression positive defined as FGFR2b ≥10% 2+/3+ TC determined 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 Evaluation Criteria 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 Criteria: * Prior treatment for metastatic or unresectable disease (Note: prior adjuvant or neo-adjuvant therapy for local disease is allowed if ended more than 6 months of 1st dose). * 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 treated disease). * Chronic or systemic ophthalmological disorders. * Major surgery or other investigational study within 28 days of first study treatment dose. * Palliative radiotherapy within 14 days of first study treatment dose. * Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer. * History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmic corticosteroids.

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Conditions

The condition(s) this trial relates to.

gastric cancer gastric neoplasm gastroesophageal cancer gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric cancer Gastroesophageal junction cancer

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Chiba University Hospital

    Chiba, Chiba, 260-8677, Japan

  • Dokkyo Medical University Hospital

    Shimotsuga-gun, Tochigi, 321-0293, Japan

  • Fujita Health University Hospital

    Toyoake-shi, Aichi-ken, 470-1192, Japan

  • Fukui Prefectural Hospital

    Fukui-shi, Fukui, 910-8526, Japan

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295, Japan

  • Gifu University Hospital

    Gifu, Gifu, 501-1194, Japan

  • Gunma Prefectural Cancer Center

    Ota-shi, Gunma, 373-8550, Japan

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511, Japan

  • Hirosaki University Hospital

    Hirosaki-shi, Aomori, 036-8563, Japan

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, Hiroshima, 730-8518, Japan

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551, Japan

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

    Minato-ku, Tokyo, 108-8639, Japan

  • Ibaraki Prefectural Central Hospital

    Kasama-shi, Ibaraki, 309-1793, Japan

  • Ishikawa Prefectural Central Hospital

    Kanazawa, Ishikawa-ken, 920-8530, Japan

  • Kagawa University Hospital

    Kita-gun, Kagawa-ken, 761-0793, Japan

  • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515, Japan

  • Kochi Health Sciences Center

    Kochi, Kochi, 781-8555, Japan

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507, Japan

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582, Japan

  • National Cancer Center

    Goyang-si Gyeonggi-do, 10408, South Korea

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • National University Hospital

    Singapore, 119074, Singapore

  • Northport Veterans Affairs Medical Center

    Northport, New York, 11768, United States

  • Ogaki Municipal Hospital

    Ogaki-shi, Gifu, 503-8502, Japan

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558, Japan

  • Osaka General Medical Center

    Osaka, Osaka, 558-8558, Japan

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki-shi, Osaka, 569-8686, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777, Japan

  • Shizuoka General Hospital

    Shizuoka, Shizuoka, 420-8527, Japan

  • St Marianna University Hospital

    Kawasaki-shi, Kanagawa, 216-8511, Japan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550, Japan

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • Toyama University Hospital

    Toyama, Toyama, 930-0194, Japan

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