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Monoclonal Antibodies

Bemarituzumab + Chemotherapy for Stomach Cancer (FORTITUDE-101 Trial)

Phase 3
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) less than or equal to 1
Participant has no contraindications to mFOLFOX6 chemotherapy
Must not have
Known human epidermal growth factor receptor 2 (HER2) positive
Evidence of or recent history (within 6 months) of corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3.5 years
Awards & highlights
Pivotal Trial

Summary

This trial is testing whether adding bemarituzumab to standard chemotherapy helps patients live longer. It targets patients whose tumors have a specific marker (FGFR2b). The treatment works by blocking a protein that helps cancer cells grow.

Who is the study for?
Adults with advanced gastric or gastroesophageal junction cancer that can't be removed by surgery, showing high levels of FGFR2b protein. They must have a good performance status (ECOG ≤1), measurable disease per RECIST criteria, and adequate organ function. Not eligible if they have brain metastases, significant heart problems, certain eye disorders, HER2 positive cancer, recent major surgery or other treatments for their cancer.
What is being tested?
The trial is testing the effectiveness of bemarituzumab combined with mFOLFOX6 chemotherapy versus a placebo plus mFOLFOX6 in improving survival rates. Bemarituzumab targets the FGFR2b protein overexpressed in some cancers.
What are the potential side effects?
Potential side effects include reactions related to infusion of bemarituzumab such as fever and chills; nerve damage causing numbness or tingling; eye issues like corneal defects; and general chemotherapy-related effects like fatigue, nausea, low blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active and can carry on all pre-disease activities without restriction.
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I can safely receive mFOLFOX6 chemotherapy.
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My tumor shows high FGFR2b levels based on a recent test.
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I have advanced stomach or gastroesophageal cancer that cannot be removed by surgery.
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My blood counts and liver/kidney functions are within safe ranges for treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is HER2 positive.
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I have had recent eye problems, including corneal defects or a corneal transplant.
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I have been treated with drugs targeting the FGF-FGFR pathway.
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I have moderate to severe numbness or tingling in my hands or feet.
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I have long-term eye problems.
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I received palliative radiotherapy within the last 14 days.
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I have brain metastases that are either untreated or causing symptoms.
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I have a serious heart condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from Baseline Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
Abdominal Pain
Change from Baseline of Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L)
+13 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bemarituzumab with mFOLFOX6Experimental Treatment2 Interventions
Group II: Placebo with mFOLFOX6Active Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bemarituzumab
2018
Completed Phase 2
~250
mFOLFOX6
2009
Completed Phase 4
~1600

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for stomach cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy drugs like 5-fluorouracil (5-FU) and oxaliplatin work by damaging the DNA of cancer cells, preventing them from dividing and growing. Targeted therapies, such as Bemarituzumab, inhibit specific proteins like FGFR2b that are overexpressed in some gastric cancers, thereby blocking the signals that promote cancer cell growth and survival. Immunotherapy leverages the body's immune system to recognize and attack cancer cells. Understanding these mechanisms is crucial for stomach cancer patients as it helps in selecting the most effective treatment based on the molecular profile of their tumor, potentially improving outcomes and minimizing unnecessary side effects.
Does tumor profile in gastric and gastroesophageal (GE) junction cancer justify off-label use of targeted therapy?-a narrative review.New and emerging combination therapies for esophageal cancer.Promising novel therapies for the treatment of endometrial cancer.

Find a Location

Who is running the clinical trial?

Zai Lab (China only)UNKNOWN
AmgenLead Sponsor
1,442 Previous Clinical Trials
1,397,197 Total Patients Enrolled
MDStudy DirectorAmgen
980 Previous Clinical Trials
940,953 Total Patients Enrolled

Media Library

Bemarituzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05052801 — Phase 3
Stomach Cancer Research Study Groups: Bemarituzumab with mFOLFOX6, Placebo with mFOLFOX6
Stomach Cancer Clinical Trial 2023: Bemarituzumab Highlights & Side Effects. Trial Name: NCT05052801 — Phase 3
Bemarituzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05052801 — Phase 3
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