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A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
303 patients around the world
Available in Brazil, Argentina, Mexico, United States
Amgen
14Research sites
303Patients around the world
This study is for people with
Solid tumors
Breast Cancer
Cervical cancer
Head and neck cancer
Lung cancer
Ovarian cancer
Requirements for the patient
To 99 Years
All Gender
Medical requirements
- Age ≥ 18 years (or legal adult age within country, whichever is older) at the time that the Informed Consent Form (ICF) is signedHistologically or cytologically confirmed cancer of one of the following types, refractory to or relapsed after at least 1 prior standard therapeutic regimen in the advanced/metastatic setting, as specified below. If no standard of care therapies exist for the participant, or the participant cannot tolerate or refuses standard of care anticancer therapy, the participant may be allowed to participate on the study after discussion between the investigator and Amgen medical monitor. Participants who have not received all approved or standard treatments for their cancer must be informed that these alternatives to receiving bemarituzumab are available prior to consenting to participate in the trial.head and neck squamous cell carcinoma: ≥ 1 line of therapytriple-negative breast cancer: ≥ 2 lines of therapyIntrahepatic cholangiocarcinoma ≥ 1 line of therapylung adenocarcinoma: at least platinum-based chemotherapy, checkpoint inhibitor, and targeted therapyplatinum resistant ovarian epithelial cell carcinoma, including fallopian tube cancers and primary peritoneal cancers, defined as progression during or within 6 months of a platinum containing regimen: ≥ 1 line of therapyendometrial adenocarcinoma: ≥ 1 line of therapycervical carcinoma: ≥ 1 line of therapyother solid tumors: ≥ 1 line of therapyDisease that is unresectable, locally advanced, or metastatic (not amenable to curative therapy)Tumor overexpresses FGFR2b as determined by centrally performed immunohistochemistry (IHC) testingMeasurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Adequate organ function as determined per protocol.
- Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease.Other solid tumor cohort excludes primary tumors of the CNS, squamous non-small cell lung cancer, gastric adenocarcinoma, and gastroesophageal junction adenocarcinomaImpaired cardiac function or clinically significant cardiac disease including: unstable angina within 6 months prior to first dose of study treatment, acute myocardial infarction ≥ 6 months prior to first dose of study treatment, New York Heart Association (NYHA) class II-IV congestive heart failure, uncontrolled hypertension (defined as an average systolic blood pressure ≥ 160 mmHg or diastolic ≥ 100 mmHg despite optimal treatment, uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, active coronary artery disease or corrected QT interval QTc ≥ 470History of systemic disease or ophthalmologic disorders requiring chronic use of ophthalmic steroidsEvidence of any ongoing ophthalmologic abnormalities or symptoms that are acute (within 4 weeks) or actively progressingUnwillingness to avoid use of contact lenses during study treatment and for at least 100 days after the end of treatmentRecent (within 6 months) corneal surgery or ophthalmic laser treatment or recent (within 6 months) history of, or evidence of, corneal defects, corneal ulcerations, keratitis, or keratoconus, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer prior/concomitant therapyPrior treatment with any investigational selective inhibitor of the fibroblast growth factor (FGF)/FGF receptor pathway (unless approved standard of care for tumor indication).
Sites
Sociedad de Beneficencia Hospital Italiano - Córdoba
Recruiting
Hospital Alemán
Recruiting
Hospital Italiano de La Plata
Recruiting
Fundación CENIT para la Investigación en Neurociencias
Recruiting
Fundación Médica de Río Negro y Neuquén - Cipolletti
Recruiting
Centro Oncológico Korben
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Instituto do Cancer Arnaldo Vieira de Carvalho
Recruiting
Oncoclínicas
Recruiting
Hospital Das Clínicas Da Universidade Federal de Minas Gerais - UFMG
Recruiting
StudyFORTITUDE-301
SponsorAmgen
Study typeInterventional
Conditions
Solid tumorsBreast CancerCervical cancerHead and neck cancerLung cancerOvarian cancer
Requirements
To 99 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05325866
