Who is the trial for?
The FORTITUDE-101 trial is currently enrolling adults with previously untreated advanced or metastatic stomach or gastroesophageal junction (GEJ) cancer who:
- Have FGFR2b overexpression*
- Have no ongoing eye-related disorders
As there are additional key eligibility requirements for the FORTITUDE-101 trial, a study doctor will review your health profile to determine if you are a candidate for the trial.
*FGFR2b (fibroblast growth factor receptor 2, isoform IIIb) is a biological marker that is being studied in stomach cancer. Abnormally elevated levels of FGFR2b may be associated with how fast the cancer spreads in the body.
Why is the trial being done?
Bemarituzumab is an investigational study drug that is designed to block the activity of FGFR2b, which may stop the cancer cell from growing and spreading throughout the body. The FORTITUDE-101 trial is studying whether bemarituzumab is a safe and effective option when added to chemotherapy like mFOLFOX6*, for adult patients with previously untreated, advanced FGFR2b-overexpressing stomach cancer.
Based on the Phase 2 FIGHT Trial that evaluated bemarituzumab with mFOLFOX6, FGFR2b is a biological marker that is found in about ~30% of adults with advanced stomach cancer. Abnormally elevated levels of FGFR2b may be associated with promoting cancer cell growth and spread; thus, supporting further investigation of FGFR2b as a biological marker in advanced stomach cancer.
*mFOLFOX6 is a combination of fluorouracil, oxaliplatin, and leucovorin, which are chemotherapy medications to treat cancer.
What will the patient be taking?
Patients in the study will be randomly assigned to one of the following groups:
- Bemarituzumab + mFOLFOX6*: Both bemarituzumab and mFOLFOX6 are given intravenously, which means that the medication will be given directly into the patient’s veins by a port or IV line.
- Placebo† + mFOLFOX6: Both are given intravenously.
Please note that all patients will receive a standard of care chemotherapy combination, but only about half of the patients will receive the investigational study drug bemarituzumab.
*mFOLFOX6 is a combination of fluorouracil, oxaliplatin, and leucovorin, which are chemotherapy medications to treat cancer.
†Placebo will not include the study drug bemarituzumab.
What is Bemarituzumab?
Bemarituzumab is an investigational molecule that is designed to block the activity of FGFR2b, which may block the cancer cell from growing and spreading in the body.
What to expect from being in the study
If you are interested in participating in the study, please note the following:
- Your study doctor may order lab tests to find out if you are eligible to participate in the study. In addition, you may need to take other lab tests and attend follow-up appointments with your doctor throughout the course of the study to monitor the treatment.
- You may receive the investigational drug, bemarituzumab.
- You may be required to travel to the study site location.
- You may experience some side effects from the treatment. The most commonly reported side effects associated with the use of bemarituzumab is the potential for dryness of the eye and inflammation of the cornea (or the transparent part of the eye). Some common side effects of mFOLFOX6 with or without bemarituzumab include: nausea, vomiting, diarrhea, irritation of the lining in the mouth, numbness of the hands and feet, decreased blood counts, abnormal liver tests.
Reference
ClinicalTrials.gov. NCT05052801. https://clinicaltrials.gov/ct2/show/NCT05052801. Accessed May 25, 2022.
Who is the trial for?
The FORTITUDE-102 trial is currently enrolling adults with previously untreated advanced or metastatic stomach or gastroesophageal junction (GEJ) cancer who:
- Have FGFR2b overexpression*
- Have no ongoing eye-related disorders
As there are additional key eligibility requirements for FORTITUDE-102, a study doctor will review your health profile to determine if you are a candidate for the trial.
*FGFR2b (fibroblast growth factor receptor 2, isoform IIIb) is a biological marker that is being studied in stomach cancer. Abnormally elevated levels of FGFR2b may be associated with how fast the cancer spreads in the body.
Why is the trial being done
Bemarituzumab is an investigational study drug that is designed to block the activity of FGFR2b, which may stop the cancer cell from growing and spreading throughout the body. The FORTITUDE-102 trial is studying whether bemarituzumab is a safe and effective option when added to mFOLFOX6* and nivolumab†, for adult patients with previously untreated, advanced FGFR2b-overexpressing stomach cancer.
Based on the Phase 2 FIGHT Trial that evaluated bemarituzumab with mFOLFOX6, FGFR2b is a biological marker that is found in about ~30% of adults with advanced stomach cancer. Abnormally elevated levels of FGFR2b may be associated with promoting cancer cell growth and spread; thus, supporting further investigation of FGFR2b as a biological marker in advanced stomach cancer.
*mFOLFOX6 is a combination of fluorouracil, oxaliplatin, and leucovorin, which are chemotherapy medications to treat cancer.
†Nivolumab is a type of medication that works with your immune system to help the body fight cancer.
What will the patient be taking?
Patients in the study will be randomly assigned to one of the following groups:
- Bemarituzumab + mFOLFOX6* + nivolumab†: All three are given intravenously, which means that the medication will be given directly into the patient’s veins by a port or IV line.
- Placebo‡ + mFOLFOX6 + nivolumab: All three are given intravenously.
Please note that all patients will receive a standard of care treatment combination, but only about half of the patients will receive the investigational study drug bemarituzumab.
*mFOLFOX6 is a combination of fluorouracil, oxaliplatin, and leucovorin, which are chemotherapy medications to treat cancer.
†Nivolumab is a type of medication that works with your immune system to help the body fight cancer.
‡Placebo will not include the study drug bemarituzumab.
What is Bemarituzuamb?
Bemarituzumab is an investigational molecule designed to block the activity of FGFR2b, which may block the cancer cell from growing and spreading in the body.
What to expect from being in the study
If you are interested in participating in the study, please note the following:
- Your study doctor may order lab tests to find out if you are eligible to participate in the study. In addition, you may need to take other lab tests and attend follow-up appointments with your doctor throughout the course of the study to monitor the treatment.
- You may also receive the investigational drug, bemarituzumab.
- You may be required to travel to the study site location.
You may experience some side effects from the treatment. The most commonly reported side effects associated with the use of bemarituzumab is the potential for dryness of the eye and inflammation of the cornea (or the transparent part of the eye). Some common side effects of mFOLFOX6 with or without bemarituzumab include: nausea, vomiting, diarrhea, irritation of the lining in the mouth, numbness of the hands and feet, decreased blood counts, abnormal liver tests.
Reference
ClinicalTrials.gov. NCT05111626. https://www.clinicaltrials.gov/ct2/show/NCT05111626. Accessed May 25, 2022.