Los objetivos primarios de este estudio son observar la seguridad y tolerabilidad de bemarituzumab y evaluar la actividad antitumoral preliminar.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 99 YearsSexo: ALL

Criterios de inclusión

Age ≥ 18 years (or legal adult age within country, whichever is older) at the time that the Informed Consent Form (ICF) is signed
Histologically 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 therapy
triple-negative breast cancer: ≥ 2 lines of therapy
Intrahepatic cholangiocarcinoma ≥ 1 line of therapy
lung adenocarcinoma: at least platinum-based chemotherapy, checkpoint inhibitor, and targeted therapy
platinum 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 therapy
endometrial adenocarcinoma: ≥ 1 line of therapy
cervical carcinoma: ≥ 1 line of therapy
other solid tumors: ≥ 1 line of therapy
Disease that is unresectable, locally advanced, or metastatic (not amenable to curative therapy)
Tumor overexpresses FGFR2b as determined by centrally performed immunohistochemistry (IHC) testing
Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function as determined per protocol.

Criterios de exclusión

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 adenocarcinoma
Impaired 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 ≥ 470
History of systemic disease or ophthalmologic disorders requiring chronic use of ophthalmic steroids
Evidence of any ongoing ophthalmologic abnormalities or symptoms that are acute (within 4 weeks) or actively progressing
Unwillingness to avoid use of contact lenses during study treatment and for at least 100 days after the end of treatment
Recent (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 therapy
Prior treatment with any investigational selective inhibitor of the fibroblast growth factor (FGF)/FGF receptor pathway (unless approved standard of care for tumor indication).

Ubicaciones

Instituto Alexander Fleming

Capital Federal, Buenos Aires, Argentina

Hospital Aleman

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Fundacion Cenit Para La Investigacion

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Italiano de La Plata

La Plata, Buenos Aires, Argentina

Sociedad de Beneficencia Hospital Italiano

Córdoba, Córdoba Province, Argentina

Fundacion Medica de Rio Negro y Neuquen

Cipolletti, Río Negro Province, Argentina

Centro Oncologico Korben

Buenos Aires, Argentina

Estudio de fase 1b/2, multicéntrico, abierto, tipo canasta, para evaluar la seguridad y eficacia de bemarituzumab en monoterapia en tumores sólidos con sobreexpresión de FGFR2b (FORTITUDE-301)

Resumen