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Evaluating a new treatment for advanced gastric cancer

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).

Phase1; Phase2 Interventional Amgen · NCT05322577

This study is testing a new treatment combining bemarituzumab with other cancer drugs to see if it helps adults with advanced gastric cancer that can’t be surgically removed.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment80 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorAmgen Industry-sponsored
Drugs / interventionsnivolumab, bemarituzumab
Locations40 sites (Northport, New York and 39 other locations)
Trial IDNCT05322577 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of bemarituzumab when combined with other anti-cancer therapies for patients with previously untreated advanced gastric or gastroesophageal junction cancer. Participants will receive bemarituzumab alongside S-1 and oxaliplatin (SOX) and nivolumab, with the aim of assessing their response to treatment. The study will include adults with unresectable cancer who have FGFR2b overexpression, as determined by tumor samples. The research will be conducted in multiple locations, including medical centers in the United States and Japan.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer who have FGFR2b overexpression.

Not a fit: Patients with resectable cancer or those who do not have FGFR2b overexpression may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced gastric cancer.

How similar studies have performed: Other studies have shown promise with similar approaches targeting FGFR2b in gastric cancer, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Northport, New York and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Gastric CancerGastroesophageal Junction CancerBemarituzumabFGFR2b Overexpression
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.