What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly monoclonal antibodies like Bemarituzumab targeting FGFR2b, often result in side effects such as partial alopecia, hair curling, and dyspigmentation. Immunotherapy agents can cause patchy hypopigmentation of the skin and hair, as well as alopecia. Other frequent side effects include fatigue, nausea, diarrhea, and potential interstitial lung disease. The severity and type of side effects can vary based on the specific treatment and individual patient response.

What prior FDA approvals exist?

Several monoclonal antibodies and targeted therapies have been approved by the FDA for the treatment of solid tumors. For example, trastuzumab targets the HER2 receptor and is used in HER2-overexpressing breast and gastric cancers. Ramucirumab targets the VEGF receptor and is used in gastric and colorectal cancers. These therapies work by inhibiting specific growth factor receptors involved in tumor growth, similar to how bemarituzumab targets FGFR2b. These approvals highlight the effectiveness of targeted therapies in managing various solid tumors.

What other types of research exist?

Promising alternatives to Bemarituzumab for solid tumors include Sacituzumab Govitecan, an antibody-drug conjugate active against refractory, metastatic triple-negative breast cancer, and Pembrolizumab, an immune checkpoint inhibitor used in combination with chemotherapy for metastatic non-small-cell lung cancer. Both have shown significant efficacy in clinical trials and are viable options for solid tumor treatment.

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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 years

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%

Epistaxis

15%

Headache

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

Palmar-plantar erythrodysesthesia synrome

Pain in extremity

Chills

General disorders and administration site conditions - Other

Localized edema

Rash maculo-papular

Sepsis

Dyspepsia/heartburn

Nasal congestion

Neck pain

Arthralgia

Colitis

Fall

Aspiration

Hematuria

Dysphagia

Sore throat

Upper respiratory infection

Urinary track infection

Aspartate aminotransferase increased

Dry skin

Flank pain

Gastrointestinal disorders - Other

Hypoxia

Proteinuria

Abdominal distenstion

Chest pain - cardiac

Alanine aminotransferase increased

Urinary incontinence

Stroke

Hyperkalemia

Tremor

Sinusitis

Periodontal disease

Urinary tract obstruction

Urinary tract infection

Bruising

Febrile neutropenia

Leukocytosis

Pneumonitis

Gastroparesis

Pelvic infection

Esophageal obstruction

Esophagitis

Small intestinal obstruction

Blood and lymphatic system disorders - Other

Death NOS

Seizure

Blurred vision

Platelet count decreased

Catheter related infection

Dehydration

Delirium

Phlebitis infective

Renal and urinary disorders - Other

Surgical and medical procedures - Other

Syncope

Upper gastrointestinal hemorrhage

Flu like symptoms

Fracture

Gastrointestinal pain

hemorrhoidal hemorrhage

Musculoskeletal and connective tissue disorder - Other

Presyncope

Renal colic

Esophageal perforation

100%

80%

60%

40%

20%

Study treatment Arm

ITT-PTS: Personalized Treatment Strategy

Non-ITT: Standard Therapy

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

0 / 19Eligibility criteria met

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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