Phase
Condition
Solid Tumors
Neoplasms
Treatment
Bemarituzumab
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years (or legal adult age within country, whichever is older) at the timethat 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 theadvanced/metastatic setting, as specified below. If no standard of care therapiesexist for the participant, or the participant cannot tolerate or refuses standard ofcare anticancer therapy, the participant may be allowed to participate on the studyafter discussion between the investigator and Amgen medical monitor. Participantswho have not received all approved or standard treatments for their cancer must beinformed that these alternatives to receiving bemarituzumab are available prior toconsenting 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, checkpointinhibitor, and targeted therapy
platinum resistant ovarian epithelial cell carcinoma, including fallopian tubecancers 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 tocurative 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
Exclusion Criteria:
Untreated or symptomatic central nervous system (CNS) metastases or leptomeningealdisease.
Other solid tumor cohort excludes primary tumors of the CNS, squamous non-small celllung 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, acutemyocardial infarction ≥ 6 months prior to first dose of study treatment, New YorkHeart Association (NYHA) class II-IV congestive heart failure, uncontrolledhypertension (defined as an average systolic blood pressure ≥ 160 mmHg or diastolic ≥ 100 mmHg despite optimal treatment, uncontrolled cardiac arrhythmias requiringanti-arrhythmic therapy other than beta blockers or digoxin, active coronary arterydisease or corrected QT interval QTc ≥ 470
History of systemic disease or ophthalmologic disorders requiring chronic use ofophthalmic 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 posean increased risk of developing a corneal ulcer prior/concomitant therapy
Prior treatment with any investigational selective inhibitor of the fibroblastgrowth factor (FGF)/FGF receptor pathway (unless approved standard of care for tumorindication).
Study Design
Connect with a study center
Instituto Alexander Fleming
Capital Federal, Buenos Aires C1426ANZ
ArgentinaSite Not Available
Fundacion Cenit Para La Investigacion
Ciudad Autonoma de Buenos Aires, Buenos Aires C1125ABD
ArgentinaSite Not Available
Hospital Aleman
Ciudad Autonoma de Buenos Aires, Buenos Aires C1118AAT
ArgentinaSite Not Available
Hospital Italiano de La Plata
La Plata, Buenos Aires 1900
ArgentinaSite Not Available
Sociedad de Beneficencia Hospital Italiano
Cordoba, Córdoba 5000
ArgentinaSite Not Available
Fundacion Medica de Rio Negro y Neuquen
Cipolletti, Río Negro 8324
ArgentinaSite Not Available
Centro Oncologico Korben
Buenos Aires, 1426
ArgentinaSite Not Available
Liverpool Hospital
Liverpool, New South Wales 2170
AustraliaSite Not Available
Prince of Wales Hospital
Randwick, New South Wales 2031
AustraliaSite Not Available
Wollongong Hospital
Wollongong, New South Wales 2500
AustraliaSite Not Available
Toowoomba Hospital
Toowoomba, Queensland 4350
AustraliaSite Not Available
Cabrini Hospital
Malvern, Victoria 3144
AustraliaSite Not Available
St John of God Murdoch Hospital
Murdoch, Western Australia 6150
AustraliaSite Not Available
Medizinische Universitaet Graz
Graz, 8036
AustriaSite Not Available
Landeskrankenhaus Salzburg
Salzburg, 5020
AustriaSite Not Available
Universitaetsklinikum Salzburg
Salzburg, 5020
AustriaActive - Recruiting
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Bruxelles, 1200
BelgiumSite Not Available
Grand Hopital de Charleroi
Charleroi, 5530
BelgiumActive - Recruiting
Grand Hopital de Charleroi - Site des Viviers
Charleroi, 6060
BelgiumSite Not Available
Universitair Ziekenhuis Antwerpen
Edegem, 2650
BelgiumSite Not Available
Universitair Ziekenhuis Gent
Gent, 9000
BelgiumSite Not Available
Grand Hopital de Charleroi - Site des Viviers
Gilly, 6060
BelgiumSite Not Available
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000
BelgiumSite Not Available
Hospital das Clinicas da Ufmg
Belo Horizonte, Minas Gerais 30130-100
BrazilSite Not Available
Centro de Oncologia Mackenzie
Curitiba, Paraná 80440-220
BrazilSite Not Available
Associacao Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande Do Sul 90035-001
BrazilSite Not Available
Beneficencia Portuguesa de Sao Paulo
Sao Paulo, São Paulo 01323-900
BrazilActive - Recruiting
Beneficencia Portuguesa de Sao Paulo - Bp
Sao Paulo, São Paulo 01323-900
BrazilSite Not Available
Instituto do Cancer Arnaldo Vieira de Carvalho
Sao Paulo, São Paulo 01221-020
BrazilSite Not Available
Oncologia Rede D Or
Sao Paulo, São Paulo 04501-000
BrazilSite Not Available
Oncologia Rede D´Or
Sao Paulo, São Paulo 04501-000
BrazilActive - Recruiting
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, 22250-905
BrazilSite Not Available
Complex Oncology Center Plovdiv EOOD
Plovdiv, 4004
BulgariaSite Not Available
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
Plovdiv, 4000
BulgariaSite Not Available
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, 1606
BulgariaSite Not Available
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
The Ottawa Hospital Cancer Centre
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Princess Margaret Cancer Centre
Toronto, Ontario M5G 1Z5
CanadaSite Not Available
Masarykuv onkologicky ustav
Brno, 656 53
CzechiaSite Not Available
Fakultni nemocnice Hradec Kralove
Hradec Kralove, 500 05
CzechiaSite Not Available
Fakultni nemocnice Olomouc
Olomouc, 779 00
CzechiaSite Not Available
Fakultni nemocnice Kralovske Vinohrady
Praha 10, 100 34
CzechiaSite Not Available
Rigshospitalet
Kobenhavn O, 2100
DenmarkSite Not Available
Docrates Syopasairaala
Helsinki, 00180
FinlandSite Not Available
Tampere University Hospital
Tampere, 33521
FinlandSite Not Available
Tampere University Hospital TAYS
Tampere, 33521
FinlandActive - Recruiting
Institut de Cancerologie de l Ouest Rene Gauducheau
Angers Cedex 02, 49055
FranceSite Not Available
Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz
Besancon, 25030
FranceSite Not Available
Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz
Besancon cedex, 25030
FranceSite Not Available
Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz
Besancon cedex, 25030
FranceActive - Recruiting
Centre Oscar Lambret
Lille Cedex, 59020
FranceSite Not Available
Institut Paoli Calmettes
Marseille Cedex 09, 13272
FranceSite Not Available
Institut regional du Cancer Montpellier
Montpellier Cedex 5, 34298
FranceSite Not Available
Centre Hospitalier Lyon Sud
Pierre-Benite, 69495
FranceActive - Recruiting
Hopital Lyon sud
Pierre-Benite, 69495
FranceSite Not Available
Institut Claudius Regaud
Toulouse cedex 9, 31059
FranceActive - Recruiting
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse cedex 9, 31059
FranceSite Not Available
Gustave Roussy
Villejuif, 94805
FranceSite Not Available
Institut Gustave Roussy
Villejuif, 94805
FranceActive - Recruiting
Alexandra Hospital
Athens, 11528
GreeceSite Not Available
Metropolitan General
Athens, 15562
GreeceSite Not Available
Sotiria General Hospital
Athens, 11527
GreeceSite Not Available
University Hospital of Heraklion
Heraklion - Crete, 71500
GreeceSite Not Available
European Interbalkan Medical Center
Thessaloniki, 57001
GreeceSite Not Available
Orszagos Onkologiai Intezet
Budapest, 1122
HungarySite Not Available
Semmelweis Egyetem
Budapest, 1082
HungarySite Not Available
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Oktatokorhaz
Nyiregyhaza, 4400
HungaryActive - Recruiting
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
Nyiregyhaza, 4400
HungarySite Not Available
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
Szolnok, 5004
HungaryActive - Recruiting
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok, 5000
HungarySite Not Available
Rambam Medical Center
Haifa, 3109601
IsraelSite Not Available
Hadassah Ein-Kerem Medical Center
Jerusalem, 9112001
IsraelSite Not Available
Rabin Medical Center
Petah Tikva, 4941492
IsraelSite Not Available
Sheba Medical Center
Ramat Gan, 5262000
IsraelSite Not Available
Tel-Aviv Sourasky Medical Center
Tel Aviv, 6423906
IsraelSite Not Available
Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS
Candiolo TO, 10060
ItalySite Not Available
Azienda Ospedaliero Universitaria Ospedali Riuniti
Foggia, 71100
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
Foggia, 71100
ItalySite Not Available
Azienda Unita Locale Socio Sanitaria 3 Presidio Ospedaliero di Mirano
Mirano, 30035
ItalySite Not Available
Azienda Unità Locale Socio Sanitaria 3 Presidio Ospedaliero di Mirano
Mirano, 30035
ItalySite Not Available
Azienda Unita Locale Socio Sanitaria 3 Presidio Ospedaliero di Mirano
Mirano VE, 30035
ItalySite Not Available
Ospedale del Mare
Napoli, 80147
ItalySite Not Available
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126
ItalyTerminated
Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara
Pisa, 56126
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
ItalySite Not Available
Azienda Ospedaliera Policlinico Umberto I
Roma, 00161
ItalySite Not Available
Aichi Cancer Center
Nagoya-shi, Aichi 464-8681
JapanSite Not Available
National Cancer Center Hospital East
Kashiwa-shi, Chiba 277-8577
JapanSite Not Available
Kindai University Hospital
Osakasayama-shi, Osaka 589-8511
JapanSite Not Available
National Cancer Center Hospital
Chuo-ku, Tokyo 104-0045
JapanSite Not Available
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo 135-8550
JapanSite Not Available
Asan Medical Center
Seoul, 138-736
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
Investigacion Onco Farmacéutica S de RL de CV
La Paz, Baja California Sur 23040
MexicoSite Not Available
Investigación Onco Farmacéutica S de RL de CV
La Paz, Baja California Sur 23040
MexicoTerminated
Centro de Infusion e InvestigacIón Oncología de Saltillo S.C.
Saltillo, Coahuila 25279
MexicoActive - Recruiting
Centro de Infusion e Investigacion Oncologia de Saltillo
Saltillo, Coahuila 25279
MexicoSite Not Available
Centro de Infusion e Investigacion Oncologia de Saltillo SC
Saltillo, Coahuila 25279
MexicoActive - Recruiting
Investigacion Biomedica para el Desarrollo de Farmacos
Ciudad de Mexico, Distrito Federal 03103
MexicoSite Not Available
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
Ciudad de Mexico, Distrito Federal 03103
MexicoActive - Recruiting
Health Pharma Professional Research SA de CV
Mexico City, Distrito Federal 03100
MexicoSite Not Available
Christus Muguerza Clinica Vidriera
Monterrey, Nuevo León 64570
MexicoSite Not Available
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
NetherlandsSite Not Available
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA
NetherlandsSite Not Available
Pratia Mcm Krakow
Krakow, 30-727
PolandSite Not Available
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338
PolandSite Not Available
Ars Medical Spzoo
Pila, 64-920
PolandSite Not Available
Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo
Siedlce, 08-110
PolandSite Not Available
Centrum Medyczne Pratia Poznan
Skorzewo, 60-185
PolandSite Not Available
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
Lisboa, 1649-035
PortugalActive - Recruiting
Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria
Lisboa, 1649-035
PortugalActive - Recruiting
Centro Hospitalar de Lisboa Ocidental, EPE, Hospital Sao Francisco Xavier
Lisboa, 1440-005
PortugalActive - Recruiting
Hospital da Luz, SA
Lisboa, 1500-650
PortugalSite Not Available
Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier
Lisboa, 1440-005
PortugalSite Not Available
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisboa, 1649-035
PortugalSite Not Available
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj Napoca, 400015
RomaniaSite Not Available
Centrul de Oncologie Sf Nectarie SRL
Craiova, 200347
RomaniaSite Not Available
Institutul Regional de Oncologie Iasi
Iasi, 700483
RomaniaSite Not Available
SC Oncomed SRL
Timisoara, 300239
RomaniaSite Not Available
Hospital Clinico Universitario Virgen de la Victoria
Malaga, Andalucía 29010
SpainSite Not Available
Hospital Quironsalud Barcelona
Barcelona, Cataluña 08023
SpainSite Not Available
Hospital Universitari Vall d Hebron
Barcelona, Cataluña 08035
SpainSite Not Available
Next Oncology IOB Hospital Quironsalud Barcelona
Barcelona, Cataluña 08023
SpainActive - Recruiting
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Galicia 15706
SpainSite Not Available
Hospital General Universitario Gregorio Maranon
Madrid, 28007
SpainSite Not Available
Kantonsspital Graubuenden
Chur, 7000
SwitzerlandSite Not Available
Hopitaux Universitaires de Geneve
Geneve, 1205
SwitzerlandSite Not Available
Hopitaux Universitaires de Geneve
Geneve 14, 1205
SwitzerlandSite Not Available
Christie Hospital
Manchester, M20 4BX
United KingdomSite Not Available
The Christie Hospital
Manchester, M20 4BX
United KingdomActive - Recruiting
Weston Park Hospital
Sheffield, S10 2SJ
United KingdomSite Not Available
City of Hope National Medical Center
Duarte, California 91010
United StatesSite Not Available
University of California Irvine
Orange, California 92868
United StatesSite Not Available
Rocky Mountain Cancer Centers
Aurora, Colorado 80012
United StatesSite Not Available
US Oncology Regulatory Affairs Corporate Office
Aurora, Colorado 80012
United StatesActive - Recruiting
US Oncology Research Investigational Products Center
Aurora, Colorado 80012
United StatesActive - Recruiting
US Oncology Regulatory Affairs Corporate Office
Denver, Colorado 80218
United StatesSite Not Available
US Oncology Research Investigational Products Center
Denver, Colorado 80218
United StatesActive - Recruiting
Community Health Network
Indianapolis, Indiana 46250
United StatesActive - Recruiting
Community Health Network MD Anderson Cancer Center - North
Indianapolis, Indiana 46250
United StatesSite Not Available
Henry Ford Hospital
Detroit, Michigan 48202
United StatesSite Not Available
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee 37203
United StatesSite Not Available
Texas Oncology - Baylor
Dallas, Texas 75246
United StatesActive - Recruiting
Texas Oncology - Dallas Fort Worth
Dallas, Texas 75246
United StatesSite Not Available
Texas Oncology-Sammons
Dallas, Texas 75246
United StatesActive - Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
US Oncology Regulatory Affairs Corporate Office
Irving, Texas 75063
United StatesActive - Recruiting
US Oncology Research Investigational Products Center
Irving, Texas 75063
United StatesSite Not Available
Texas Oncology Northeast Texas
Tyler, Texas 75702
United StatesSite Not Available
Texas Oncology-Tyler
Tyler, Texas 75702
United StatesActive - Recruiting
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