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Monoclonal Antibodies

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

Phase 3

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3.5 years

Awards & highlights

FORTITUDE-101 Trial Summary

This trial is testing if adding the drug bemarituzumab to standard chemotherapy can help people with colorectal cancer live longer.

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.Check my eligibility

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.See study design

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.

FORTITUDE-101 Trial 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.

FORTITUDE-101 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

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)

+16 more

FORTITUDE-101 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

~1400

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Zai Lab (China only)UNKNOWN

AmgenLead Sponsor

1,370 Previous Clinical Trials

1,377,172 Total Patients Enrolled

MDStudy DirectorAmgen

913 Previous Clinical Trials

923,615 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Where is this test being taken place?

"At the moment, this research is being conducted in 16sites. These include locations in Montreal, Indianapolis and Rochester as well as other cities 16 other locations. If you are considering enrolling, it might be helpful to choose the clinic nearest you to reduce travel time demands."

Answered by AI

Are there any other similar drugs to Bemarituzumab that have been tested in clinical trials?

"Bemarituzumab was first researched in 2022 at Nacionalinis vezio institutas. Out of the 18,299 completed trials to date, 2 are ongoing with many taking place in Montreal, Quebec."

Answered by AI

Has there been any similar research on this topic previously?

"Bemarituzumab has been studied since the year 2022, when Amgen sponsored its first Phase 3 clinical trial. 516 patients were observed in the initial study. Since then, there have been 2 more trials involving this medication which are currently taking place across 95 cities and 31 countries."

Answered by AI

If an adult is interested in participating, are they eligible for this research?

"According to the eligibility requirements for this trial, people aged 18 to 100 may apply. There are 31 studies specifically designed for patients under 18 and 1478 trials involving participants 65 or older."

Answered by AI

Are people able to sign up for this clinical trial at this time?

"The study, which is currently recruiting patients, was originally posted on clinicaltrials.gov on March 7th, 2022. The information hosted there was most recently updated November 9th, of the same year."

Answered by AI

Has Bemarituzumab been given the green light by the FDA?

"Bemarituzumab is a Phase 3 trial drug, meaning that it has undergone multiple rounds of testing and there is some data supporting its efficacy. Power gave it a safety rating of 3."

Answered by AI

How can I sign up for this clinical trial?

"This cancer treatment clinical trial has 516 available spots for patients aged 18 to 100 that have stomach cancer. Key eligibility requirements participants must meet are as follows: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease), Adults with unresectable, locally advanced or metastatic gast"

Answered by AI

How many people will be included in this experiment?

"The sponsor, Amgen, needs 516 eligible patients to run the study out of various medical facilities like Jewish General Hospital in Montreal and Saint Francis Medical Group located in Indianapolis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

2022. "Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05052801.

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