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Monoclonal Antibodies
Bemarituzumab for Solid Cancers (FORTITUDE-301 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years (or legal adult age within country, whichever is older) at the time that the Informed Consent Form (ICF) is signed
Tumor overexpresses FGFR2b as determined by centrally performed immunohistochemistry (IHC) testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights
FORTITUDE-301 Trial Summary
This trial is testing a new cancer drug to see if it is safe and effective.
Who is the study for?
Adults with certain advanced solid tumors that have grown or returned after treatment can join this trial. They must have tried at least one standard therapy, be in good physical condition (ECOG 0-1), and their tumor must show high levels of FGFR2b protein. People with untreated brain metastases, significant heart issues, eye problems requiring steroids, or those who've had recent corneal surgery cannot participate.Check my eligibility
What is being tested?
The study is testing the safety and potential cancer-fighting ability of a drug called Bemarituzumab in patients whose tumors overexpress FGFR2b. It's for those who've already undergone other treatments without success.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones for cancer drugs like Bemarituzumab may include fatigue, nausea, diarrhea, skin reactions and increased risk of infections. Heart function might also be affected given the exclusion criteria related to cardiac issues.
FORTITUDE-301 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old or considered an adult in my country.
Select...
My tumor has high levels of FGFR2b.
Select...
I have had platinum-based chemo, checkpoint inhibitors, and targeted therapy for lung adenocarcinoma.
Select...
My cancer has returned or didn't respond to at least one treatment.
Select...
My ovarian cancer did not respond to platinum-based treatment within 6 months.
Select...
I have received at least one treatment for my solid tumor.
Select...
I am fully active or can carry out light work.
Select...
I have had at least one treatment for cervical cancer.
Select...
I have bile duct cancer and have received at least one treatment.
Select...
My condition cannot be cured with surgery.
Select...
I have triple-negative breast cancer and have undergone at least 2 treatments.
Select...
I have had at least one treatment for my head or neck cancer.
FORTITUDE-301 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 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)
Therapeutic procedure
Part 1: Number of Participants Who Experience a Treatment-related Adverse Event
+1 moreSecondary outcome measures
Part 1: OR Rate
Part 2: Number of Participants Who Experience a TEAE
Part 2: Number of Participants Who Experience a Treatment-related AE
+8 moreSide effects data
From 2020 Phase 2 trial • 80 Patients • NCT0221328994%
Fatigue
85%
Neuropathy-sensory
76%
Nausea
63%
Diarrhea
60%
Anorexia
54%
Abdominal pain
47%
Constipation
46%
Vomiting
40%
Dysphagia, esophagitis, odynophagia
38%
Dysgeusia
31%
Weight loss
29%
Pain
29%
Edema limbs
29%
Back pain
29%
Anemia
28%
Paresthesia
25%
Dyspnea
25%
Fever
24%
Cough
21%
Dizzines
21%
Platelet count decreases
19%
Gastroesophagial reflux disease
19%
Mucositis oral
15%
Headache
15%
Epistaxis
15%
Hypertension
15%
Mood aleration - depression
13%
Thromboembolic event
13%
Hypokalemia
12%
Rash acneiform
12%
Pleural effusion
12%
Ascites
12%
Insomnia
12%
Neutrophil count decreased
12%
Non-cardiac chest pain
10%
Alopecia
10%
Generalized muscle weakness
10%
Bloating
10%
Blood bilirubin increased
10%
Hypotension
9%
Pain in extremity
9%
Palmar-plantar erythrodysesthesia synrome
9%
Chills
9%
General disorders and administration site conditions - Other
9%
Localized edema
9%
Rash maculo-papular
7%
Dyspepsia/heartburn
7%
Sepsis
7%
Nasal congestion
7%
Neck pain
7%
Arthralgia
7%
Colitis
7%
Fall
6%
Hematuria
6%
Dysphagia
6%
Aspiration
6%
Sore throat
6%
Upper respiratory infection
6%
Urinary track infection
6%
Aspartate aminotransferase increased
6%
Dry skin
6%
Flank pain
6%
Gastrointestinal disorders - Other
6%
Hypoxia
6%
Proteinuria
6%
Abdominal distenstion
4%
Chest pain - cardiac
4%
Alanine aminotransferase increased
4%
Urinary incontinence
3%
Stroke
3%
Hyperkalemia
3%
Tremor
3%
Sinusitis
3%
Periodontal disease
3%
Urinary tract obstruction
3%
Urinary tract infection
3%
Bruising
3%
Febrile neutropenia
3%
Leukocytosis
3%
Pneumonitis
1%
Pelvic infection
1%
Esophagitis
1%
Esophageal obstruction
1%
Gastroparesis
1%
Small intestinal obstruction
1%
Blood and lymphatic system disorders - Other
1%
Death NOS
1%
Seizure
1%
Blurred vision
1%
Platelet count decreased
1%
Catheter related infection
1%
Dehydration
1%
Delirium
1%
Phlebitis infective
1%
Renal and urinary disorders - Other
1%
Surgical and medical procedures - Other
1%
Syncope
1%
Upper gastrointestinal hemorrhage
1%
Flu like symptoms
1%
Fracture
1%
Gastrointestinal pain
1%
hemorrhoidal hemorrhage
1%
Musculoskeletal and connective tissue disorder - Other
1%
Presyncope
1%
Renal colic
1%
Esophageal perforation
100%
80%
60%
40%
20%
0%
Study treatment Arm
ITT-PTS: Personalized Treatment Strategy
Non-ITT: Standard Therapy
FORTITUDE-301 Trial Design
2Treatment groups
Experimental Treatment
Group I: Part 2: Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants across multiple primary epithelial solid tumors with centrally determined FGFR2b overexpression and relapsed/refractory unresectable and/or metastatic disease will receive the dose of bemarituzumab identified as the recommended Phase 2 dose during Part 1.
Group II: Part 1: Monotherapy Dose ExplorationExperimental Treatment1 Intervention
Participants across multiple primary epithelial solid tumors with centrally determined FGFR2b overexpression and relapsed/refractory unresectable and/or metastatic disease will receive 1 of 2 dose regimens of bemarituzumab to determine recommended Phase 2 dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bemarituzumab
Not yet FDA approved
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,371 Previous Clinical Trials
1,377,834 Total Patients Enrolled
MDStudy DirectorAmgen
914 Previous Clinical Trials
924,307 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastases or leptomeningeal disease that is either untreated or causing symptoms.I am at least 18 years old or considered an adult in my country.I have recent or worsening eye problems.I am aware of all approved treatments for my cancer before considering bemarituzumab.My tumor has high levels of FGFR2b.My organs are functioning well.I have had platinum-based chemo, checkpoint inhibitors, and targeted therapy for lung adenocarcinoma.I have not been treated with experimental drugs targeting the FGF pathway, unless it's a standard treatment for my cancer.I have had serious heart problems or uncontrolled high blood pressure recently.My cancer has returned or didn't respond to at least one treatment.I am willing to not wear contact lenses during and for 100 days after treatment.I haven't had eye surgery or laser treatment, nor do I have corneal issues, in the last 6 months.I have received at least one treatment for my solid tumor.My cancer is not in the brain, squamous NSCLC, stomach, or where the stomach meets the esophagus.I am fully active or can carry out light work.My cancer has returned or didn't respond to at least one treatment.My ovarian cancer did not respond to platinum-based treatment within 6 months.I use eye steroids regularly for a chronic condition.I have had at least one treatment for cervical cancer.I have bile duct cancer and have received at least one treatment.I have had at least one treatment for endometrial cancer.My condition cannot be cured with surgery.I have triple-negative breast cancer and have undergone at least 2 treatments.I have had at least one treatment for my head or neck cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: Monotherapy Dose Exploration
- Group 2: Part 2: Monotherapy Dose Expansion
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.
Does this medical experiment permit persons over 18 to participate?
"This medical study is open to individuals aged 18-99. There are 318 studies available for minors, and 2389 trials accessible to seniors."
Answered by AI
Is there an opportunity for me to participate in this clinical investigation?
"The requirements for enrolling in this clinical trial are tumors of solid origin and an age between 18 and 99. In total, about 303 participants will be accepted into the study."
Answered by AI
Is enrollment currently open for this experiment?
"The information available on clinicaltrials.gov indicates that this study is in the process of enrolling participants, with its first posting to the website occurring on September 23rd 2022 and last edit being done on November 22nd 2022."
Answered by AI
How many health care facilities are currently executing the trial?
"Currently, this research trial is recruiting participants from 9 distinct medical sites. These are based in Indianapolis, Aurora, Tyler and various other cities. It would be advisable to select the closest clinic available to you so as to reduce any travelling issues should you decide to participate."
Answered by AI
How many individuals have registered for this medical experiment?
"This clinical trial necessitates 303 participants who qualify for the specified inclusion criteria. Affected individuals may partake in this study from different locations including Community Health Network, Indianapolis in and US Oncology Regulatory Affairs Corporate Office located in Aurora CO."
Answered by AI
Has the FDA ratified Part 2: Monotherapy Dose Expansion?
"Due to the initial nature of this experiment, with only limited data available on its safety and effectiveness, our team at Power determined that Part 2: Monotherapy Dose Expansion should be rated 1 out of 3."
Answered by AI
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