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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
Must not have
Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease
Prior treatment with any investigational selective inhibitor of the fibroblast growth factor (FGF)/FGF receptor pathway (unless approved standard of care for tumor indication).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing bemarituzumab, a new medication, to see if it is safe and can help fight tumors in patients, especially when other treatments have not worked well. Bemarituzumab has been previously studied for certain types of cancer.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 18 years old or considered an adult in my country.
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My tumor has high levels of FGFR2b.
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I have had platinum-based chemo, checkpoint inhibitors, and targeted therapy for lung adenocarcinoma.
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My cancer has returned or didn't respond to at least one treatment.
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My ovarian cancer did not respond to platinum-based treatment within 6 months.
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I have received at least one treatment for my solid tumor.
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I am fully active or can carry out light work.
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I have had at least one treatment for cervical cancer.
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I have bile duct cancer and have received at least one treatment.
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My condition cannot be cured with surgery.
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I have triple-negative breast cancer and have undergone at least 2 treatments.
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I have had at least one treatment for my head or neck cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have brain metastases or leptomeningeal disease that is either untreated or causing symptoms.
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I have not been treated with experimental drugs targeting the FGF pathway, unless it's a standard treatment for my cancer.
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I have had serious heart problems or uncontrolled high blood pressure recently.
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I am willing to not wear contact lenses during and for 100 days after treatment.
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I haven't had eye surgery or laser treatment, nor do I have corneal issues, in the last 6 months.
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My cancer is not in the brain, squamous NSCLC, stomach, or where the stomach meets the esophagus.
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I use eye steroids regularly for a chronic condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Therapeutic procedure
Part 2: Objective Response (OR) Rate
Secondary study objectives
Part 1: OR Rate
Part 2: Number of Participants Who Experience a TEAE
Parts 1 and 2: Disease Control (DC) Rate
+3 more

Side effects data

From 2020 Phase 2 trial • 80 Patients • NCT02213289
94%
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%
Edema limbs
29%
Pain
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%
Palmar-plantar erythrodysesthesia synrome
9%
Pain in extremity
9%
Chills
9%
General disorders and administration site conditions - Other
9%
Localized edema
9%
Rash maculo-papular
7%
Sepsis
7%
Dyspepsia/heartburn
7%
Nasal congestion
7%
Neck pain
7%
Arthralgia
7%
Colitis
7%
Fall
6%
Hematuria
6%
Aspiration
6%
Dysphagia
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%
Gastroparesis
1%
Pelvic infection
1%
Esophageal obstruction
1%
Esophagitis
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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
Monoclonal antibodies, such as bemarituzumab, target specific proteins on cancer cells to inhibit tumor growth. Bemarituzumab specifically targets FGFR2b, a receptor involved in cell growth and survival, thereby blocking the signaling pathways that promote tumor proliferation. This targeted approach is crucial for solid tumor patients as it offers a more precise treatment, potentially reducing side effects and improving efficacy compared to traditional chemotherapy. By focusing on specific molecular targets, these therapies can disrupt cancer cell functions while sparing normal cells, leading to better patient outcomes.
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Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,433 Previous Clinical Trials
1,394,839 Total Patients Enrolled
MDStudy DirectorAmgen
971 Previous Clinical Trials
939,011 Total Patients Enrolled

Media Library

Bemarituzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05325866 — Phase 1 & 2
Solid Tumors Research Study Groups: Part 1: Monotherapy Dose Exploration, Part 2: Monotherapy Dose Expansion
Solid Tumors Clinical Trial 2023: Bemarituzumab Highlights & Side Effects. Trial Name: NCT05325866 — Phase 1 & 2
Bemarituzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05325866 — Phase 1 & 2
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