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Gastric CancerPhase 1/2FORTITUDE-103NCT05322577

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

A Phase 1/2 study testing Bemarituzumab, CAPOX and SOX in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Amgen at 42 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Bemarituzumab, CAPOX and SOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
42 sitesin 5 countries
Study dates
17 May 2022to 21 Nov 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • Participant has no contradictions to CAPOX/SOX plus or minus nivolumab.
  • Adequate organ function.
  • For Part 2, measurable disease according to RECIST v1.1.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

42 sites in 5 countries.

42 sites in 5 countries

Japan31 sites

  • Chiba University Hospital

    Chiba, Chiba, 260-8677

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • Fukui Prefectural Hospital

    Fukui-shi, Fukui, 910-8526

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

  • Gifu University Hospital

    Gifu, Gifu, 501-1194

  • Hirosaki University Hospital

    Hirosaki-shi, Aomori, 036-8563

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, Hiroshima, 730-8518

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • Ishikawa Prefectural Central Hospital

    Kanazawa, Ishikawa-ken, 920-8530

  • Ibaraki Prefectural Central Hospital

    Kasama-shi, Ibaraki, 309-1793

  • St Marianna University Hospital

    Kawasaki-shi, Kanagawa, 216-8511

  • Kagawa University Hospital

    Kita-gun, Kagawa-ken, 761-0793

  • Kochi Health Sciences Center

    Kochi, Kochi, 781-8555

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

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

    Minato-ku, Tokyo, 108-8639

  • Ogaki Municipal Hospital

    Ogaki-shi, Gifu, 503-8502

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • Osaka General Medical Center

    Osaka, Osaka, 558-8558

  • Gunma Prefectural Cancer Center

    Ota-shi, Gunma, 373-8550

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Dokkyo Medical University Hospital

    Shimotsuga-gun, Tochigi, 321-0293

  • Shizuoka General Hospital

    Shizuoka, Shizuoka, 420-8527

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki-shi, Osaka, 569-8686

  • Toyama University Hospital

    Toyama, Toyama, 930-0194

  • Fujita Health University Hospital

    Toyoake-shi, Aichi-ken, 470-1192

  • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

South Korea7 sites

  • National Cancer Center

    Goyang-si Gyeonggi-do, 10408

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

Taiwan2 sites

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

United States1 site

  • Northport Veterans Affairs Medical Center

    Northport, New York, 11768

Other trials in United States

Singapore1 site

  • National University Hospital

    Singapore, 119074

Other trials in Singapore

About this study

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).

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.

Being tested
Bemarituzumab, CAPOX, SOX, Nivolumab
Keywords
Gastric Cancer, Gastroesophageal Junction Cancer, Bemarituzumab, FGFR2b Overexpression
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BemarituzumabDrug

    Intravenous (IV) infusion

  • CAPOXDrug

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

  • SOXDrug

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

  • NivolumabDrug

    IV infusion.

Study groups in NCT05322577
Study groupRoleWhat they receive
Part 1 Cohort A: Bemarituzumab with CAPOXExperimentalNot described
Receives: Drug: Bemarituzumab; Drug: CAPOX
Part 1 Cohort C: Bemarituzumab with CAPOX and NivolumabExperimentalNot described
Receives: Drug: Bemarituzumab; Drug: CAPOX; Drug: Nivolumab
Part 1 Cohort D: Bemarituzumab with SOX and NivolumabExperimentalNot described
Receives: Drug: Bemarituzumab; Drug: SOX; Drug: Nivolumab
Part 2: Bemarituzumab with SOX and Nivolumab.ExperimentalNot described
Receives: Drug: Bemarituzumab; Drug: SOX; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT)

    Measured: Day 1 up to Day 21

  2. Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)

    Measured: Day 1 to end of treatment (up to approximately 1 year)

  3. Part 2: Objective Response (OR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Measured: Up to 30 Months

Secondary outcomes (14)

  1. Part 1: Area Under the Concentration-time Curve (AUC) of Bemarituzumab

    Measured: Day 1 to end of treatment (up to approximately 1 year)

  2. Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab

    Measured: Day 1 to end of treatment (up to approximately 1 year))

  3. Part 1: Observed Concentration at the end of a Dose Interval (Ctrough) of Bemarituzumab

    Measured: Day 1 to end of treatment (up to approximately 1 year)

  4. Part 1: OR per RECIST v1.1

    Measured: Up to 2 years

  5. Part 1: Duration of Response (DoR) per RECIST v1.1

    Measured: Up to 2 years

  6. Part 1: Disease Control Rate (DCR)

    Measured: Up to 2 years

  7. Part 1: Progression-free Survival (PFS) per RECIST v1.1

    Measured: Up to 2 years

  8. Part 1: Overall Survival (OS)

    Measured: Up to 2 years

  9. Part 2: Number of Participants Who Experience TEAEs

    Measured: Up to 30 months

  10. Part 2: DoR per RECIST v1.1

    Measured: Up to 30 months

  11. Part 2: Time to Response (TTR) per RECIST v1.1

    Measured: Up to 30 months

  12. Part 2: Disease Control (DC) per RECIST v1.1

    Measured: Up to 30 months

  13. Part 2: PFS per RECIST v1.1

    Measured: Up to 30 months

  14. Part 2: OS

    Measured: Up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2022
  2. Study start17 May 2022
  3. Primary completion21 Nov 2025
  4. Study completion21 Nov 2025

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05322577
Sponsor's protocol ID
20210099
Acronym
FORTITUDE-103
Status last verified
Jul 2026
First submitted
4 Apr 2022
Last updated
29 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Bemarituzumab, CAPOX and SOX in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Amgen at 42 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in Japan, South Korea, Taiwan, United States, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT) (time frame: Day 1 up to Day 21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05322577.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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