What side effects are associated with this type of intervention?

Common treatments for stomach cancer, such as the combination of Bemarituzumab with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU), often result in side effects like nausea, vomiting, fatigue, and diarrhea. Other targeted therapies and chemotherapeutic agents used in similar contexts may also cause skin toxicity, mucositis, and gastrointestinal issues. These side effects are consistent with those observed in various clinical trials for advanced gastric cancer treatments.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of stomach cancer have included various targeted therapies and chemotherapeutic agents. While specific FGFR2b inhibitors like Bemarituzumab are still under investigation, other targeted therapies such as trastuzumab, a monoclonal antibody targeting HER2, have been approved for HER2-positive gastric cancer. Additionally, ramucirumab, a VEGFR-2 antagonist, has been approved for advanced gastric cancer. These treatments, often used in combination with chemotherapy, represent the ongoing efforts to target specific molecular pathways in stomach cancer.

What other types of research exist?

Promising alternatives to Bemarituzumab for stomach cancer patients include: 1) Ramucirumab combined with paclitaxel, which has shown efficacy as a second-line therapy. 2) Pembrolizumab, an immunotherapy option for patients with PD-L1 positive tumors. 3) Trifluridine/tipiracil, which has demonstrated benefits in heavily pretreated metastatic gastric cancer. 4) Atezolizumab, another immunotherapy agent being evaluated in combination with chemotherapy. These treatments have shown potential in clinical trials and may be considered for patients in 2024.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3.5 years

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

0 / 13Eligibility criteria met

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.

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