Breast Cancer Clinical Trial

A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

Summary

The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

303

Study ID:

NCT05325866

Recruitment Status:

Recruiting

Sponsor:

Amgen

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There are 40 Locations for this study

See Locations Near You

City of Hope National Medical Center
Duarte California, 91010, United States
Rocky Mountain Cancer Centers
Aurora Colorado, 80012, United States
US Oncology Regulatory Affairs Corporate Office
Aurora Colorado, 80012, United States
US Oncology Research Investigational Products Center
Aurora Colorado, 80012, United States
Community Health Network
Indianapolis Indiana, 46250, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Texas Oncology - Baylor
Dallas Texas, 75246, United States
Texas Oncology-Tyler
Tyler Texas, 75702, United States
Prince of Wales Hospital
Randwick New South Wales, 2031, Australia
St John of God Murdoch Hospital
Murdoch Western Australia, 6150, Australia
Universitaetsklinikum Salzburg
Salzburg , 5020, Austria
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Bruxelles , 1200, Belgium
Grand Hopital de Charleroi
Charleroi , 5530, Belgium
Universitair Ziekenhuis Antwerpen
Edegem , 2650, Belgium
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven , 3000, Belgium
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Masarykuv onkologicky ustav
Brno , 656 5, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Fakultni nemocnice Olomouc
Olomouc , 779 0, Czechia
Centre Hospitalier Lyon Sud
Pierre-Benite , 69495, France
Sotiria General Hospital
Athens , 11527, Greece
University Hospital of Heraklion
Heraklion - Crete , 71500, Greece
European Interbalkan Medical Center
Thessaloniki , 57001, Greece
Orszagos Onkologiai Intezet
Budapest , 1122, Hungary
Aichi Cancer Center
Nagoya-shi Aichi, 464-8, Japan
National Cancer Center Hospital East
Kashiwa-shi Chiba, 277-8, Japan
Kindai University Hospital
Osakasayama-shi Osaka, 589-8, Japan
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku Tokyo, 135-8, Japan
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital Yonsei University Health System
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Asan Medical Center
Seoul , 138-7, Korea, Republic of
Centro de Infusion e Investigacion Oncologia de Saltillo SC
Saltillo Coahuila, 25279, Mexico
Instytut Centrum Zdrowia Matki Polki
Lodz , 93-33, Poland
Centrum Medyczne Pratia Poznan
Skorzewo , 60-18, Poland
Hospital Clinico Universitario Virgen de la Victoria
Malaga Andalucía, 29010, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela Galicia, 15706, Spain
Kantonsspital Graubuenden
Chur , 7000, Switzerland
Hopitaux Universitaires de Geneve
Geneve , 1205, Switzerland
Weston Park Hospital
Sheffield , S10 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

303

Study ID:

NCT05325866

Recruitment Status:

Recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

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