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Monoclonal Antibodies
Bemarituzumab + Chemotherapy for Stomach Cancer (FORTITUDE-103 Trial)
Phase 1
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amendable to curative therapy.
Easter Cooperative Oncology Group (ECOG) performance score less than or equal to 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
FORTITUDE-103 Trial Summary
This trialtests a drug to see if it is safe and effective when taken with other cancer treatments.
Who is the study for?
This trial is for adults with advanced gastric or gastroesophageal junction cancer that can't be removed by surgery. Participants must have a performance score indicating they are relatively active, provide a tumor sample, and have no prior treatments for metastatic disease. They should not have certain heart diseases, brain metastases, severe neuropathy, recent major surgery or other cancers within the last 2 years.Check my eligibility
What is being tested?
The study tests bemarituzumab combined with chemotherapy (CAPOX or SOX) and possibly nivolumab in patients who haven't been treated before for their advanced stomach tumors. It aims to assess how safe this combination is and how well patients tolerate it.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, increased risk of infection due to immune system suppression from chemotherapy and nivolumab, organ inflammation from bemarituzumab, as well as general side effects like fatigue and digestive issues.
FORTITUDE-103 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My stomach cancer cannot be surgically removed and is advanced.
Select...
I am fully active or have some restrictions but can still take care of myself.
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I can safely receive CAPOX/SOX with or without nivolumab.
FORTITUDE-103 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Part 2: Objective Response (OR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Secondary outcome measures
Part 1: Area Under the Concentration-time Curve (AUC) of Bemarituzumab
Part 1: Disease Control Rate (DCR)
Part 1: Duration of Response (DoR) per RECIST v1.1
+11 moreFORTITUDE-103 Trial Design
4Treatment groups
Experimental Treatment
Group I: Part 2: Bemarituzumab with SOX and Nivolumab.Experimental Treatment3 Interventions
Group II: Part 1 Cohort D: Bemarituzumab with SOX and NivolumabExperimental Treatment3 Interventions
Group III: Part 1 Cohort C: Bemarituzumab with CAPOX and NivolumabExperimental Treatment3 Interventions
Group IV: Part 1 Cohort A: Bemarituzumab with CAPOXExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bemarituzumab
2018
Completed Phase 2
~250
SOX
2018
Completed Phase 2
~350
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,371 Previous Clinical Trials
1,378,026 Total Patients Enrolled
MDStudy DirectorAmgen
914 Previous Clinical Trials
924,499 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received palliative radiotherapy within the last 14 days.My organs are working well.I can provide a recent or new tumor sample for the study.I haven't had treatment for advanced cancer but may have had treatment for early-stage cancer over 6 months ago.My cancer shows high FGFR2b levels as confirmed by a specific test.My stomach cancer cannot be surgically removed and is advanced.I am fully active or have some restrictions but can still take care of myself.I experience significant numbness or pain in my hands or feet.I haven't had major surgery or joined another study in the last 28 days.My cancer can be measured or tracked using specific criteria.I can safely receive CAPOX/SOX with or without nivolumab.My cancer is HER2 positive.I have brain metastases or CNS disease that hasn't been treated or is causing symptoms.I have long-term eye problems.My eyes have a condition that could lead to a corneal ulcer.I have a serious heart condition.I have been treated with drugs targeting the FGF-FGFR pathway.I have not had any other cancer in the last 2 years, except for one that was definitively treated.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 Cohort C: Bemarituzumab with CAPOX and Nivolumab
- Group 2: Part 1 Cohort A: Bemarituzumab with CAPOX
- Group 3: Part 2: Bemarituzumab with SOX and Nivolumab.
- Group 4: Part 1 Cohort D: Bemarituzumab with SOX and Nivolumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the upper age limit set for enrolment in this trial inclusive of octogenarians?
"According to this research protocol, the permissible range for participant age is 18-100 years old."
Answered by AI
Is enrollment for this research project still available?
"As indicated on clinicaltrials.gov, this trial is actively enrolling patients and has been updated as recently as January 4th of 2023. This research opportunity was initially posted on May 17th 2022."
Answered by AI
What has been the safety profile of utilizing Bemarituzumab with SOX and Nivolumab for patients?
"Our experts at Power granted Cohort D: Bemarituzumab with SOX and Nivolumab a score of 1 on our safety scale, as this is an initial Phase 1 trial that has provided limited evidence regarding its efficacy and safety."
Answered by AI
What is the peak patient enrollment for this experiment?
"Affirmative. The information on clinicaltrials.gov indicates that the study, which was initially posted on May 17th 2022 is still recruiting patients. 30 people are required to be enrolled from a single medical site."
Answered by AI
Can I be considered to join this medical exploration?
"This medical trial seeks 30 individuals diagnosed with malignant neoplasms ranging from 18 to 100 years of age. These patients must meet the following standards: have an ECOG performance score no greater than 1, provide a tumor sample that can be evaluated by RECIST v1.1 , and FGFR2b overexpression determined through IHC; furthermore, they cannot contradict CAPOX/SOX plus or minus nivolumab nor demonstrate inadequate organ function."
Answered by AI
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