Phase
Condition
Neoplasms
Solid Tumors
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
ArgentinaActive - Recruiting
Fundacion Cenit Para La Investigacion
Ciudad Autonoma de Buenos Aires, Buenos Aires C1125ABD
ArgentinaActive - Recruiting
Hospital Aleman
Ciudad Autonoma de Buenos Aires, Buenos Aires C1118AAT
ArgentinaActive - Recruiting
Hospital Italiano de La Plata
La Plata, Buenos Aires 1900
ArgentinaActive - Recruiting
Sociedad de Beneficencia Hospital Italiano
Cordoba, Córdoba 5000
ArgentinaActive - Recruiting
Fundacion Medica de Rio Negro y Neuquen
Cipolletti, Río Negro 8324
ArgentinaActive - Recruiting
Centro Oncologico Korben
Buenos Aires, 1426
ArgentinaActive - Recruiting
Liverpool Hospital
Liverpool, New South Wales 2170
AustraliaActive - Recruiting
Prince of Wales Hospital
Randwick, New South Wales 2031
AustraliaActive - Recruiting
Wollongong Hospital
Wollongong, New South Wales 2500
AustraliaActive - Recruiting
Toowoomba Hospital
Toowoomba, Queensland 4350
AustraliaTerminated
Cabrini Hospital
Malvern, Victoria 3144
AustraliaTerminated
St John of God Murdoch Hospital
Murdoch, Western Australia 6150
AustraliaActive - Recruiting
Medizinische Universitaet Graz
Graz, 8036
AustriaActive - Recruiting
Landeskrankenhaus Salzburg
Salzburg, 5020
AustriaCompleted
Universitaetsklinikum Salzburg
Salzburg, 5020
AustriaActive - Recruiting
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Bruxelles, 1200
BelgiumActive - Recruiting
Grand Hopital de Charleroi
Charleroi, 5530
BelgiumActive - Recruiting
Grand Hopital de Charleroi - Site des Viviers
Charleroi, 6060
BelgiumActive - Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, 2650
BelgiumActive - Recruiting
Universitair Ziekenhuis Gent
Gent, 9000
BelgiumActive - Recruiting
Grand Hopital de Charleroi - Site des Viviers
Gilly, 6060
BelgiumSite Not Available
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000
BelgiumActive - Recruiting
Hospital das Clinicas da Ufmg
Belo Horizonte, Minas Gerais 30130-100
BrazilActive - Recruiting
Centro de Oncologia Mackenzie
Curitiba, Paraná 80440-220
BrazilActive - Recruiting
Associacao Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande Do Sul 90035-001
BrazilActive - Recruiting
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
BrazilActive - Recruiting
Instituto do Cancer Arnaldo Vieira de Carvalho
Sao Paulo, São Paulo 01221-020
BrazilActive - Recruiting
Oncologia Rede D Or
Sao Paulo, São Paulo 04501-000
BrazilActive - Recruiting
Oncologia Rede D´Or
Sao Paulo, São Paulo 04501-000
BrazilActive - Recruiting
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, 22250-905
BrazilActive - Recruiting
Complex Oncology Center Plovdiv EOOD
Plovdiv, 4004
BulgariaActive - Recruiting
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
Plovdiv, 4000
BulgariaActive - Recruiting
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, 1606
BulgariaActive - Recruiting
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaActive - Recruiting
The Ottawa Hospital Cancer Centre
Ottawa, Ontario K1H 8L6
CanadaActive - Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario M5G 1Z5
CanadaActive - Recruiting
Masarykuv onkologicky ustav
Brno, 656 53
CzechiaActive - Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Kralove, 500 05
CzechiaActive - Recruiting
Fakultni nemocnice Olomouc
Olomouc, 779 00
CzechiaActive - Recruiting
Fakultni nemocnice Kralovske Vinohrady
Praha 10, 100 34
CzechiaCompleted
Rigshospitalet
Kobenhavn O, 2100
DenmarkActive - Recruiting
Docrates Syopasairaala
Helsinki, 00180
FinlandActive - Recruiting
Tampere University Hospital
Tampere, 33521
FinlandActive - Recruiting
Tampere University Hospital TAYS
Tampere, 33521
FinlandActive - Recruiting
Institut de Cancerologie de l Ouest Rene Gauducheau
Angers Cedex 02, 49055
FranceActive - Recruiting
Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz
Besancon, 25030
FranceActive - Recruiting
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
FranceActive - Recruiting
Institut Paoli Calmettes
Marseille Cedex 09, 13272
FranceActive - Recruiting
Institut regional du Cancer Montpellier
Montpellier Cedex 5, 34298
FranceActive - Recruiting
Centre Hospitalier Lyon Sud
Pierre-Benite, 69495
FranceActive - Recruiting
Hopital Lyon sud
Pierre-Benite, 69495
FranceActive - Recruiting
Institut Claudius Regaud
Toulouse cedex 9, 31059
FranceActive - Recruiting
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse cedex 9, 31059
FranceActive - Recruiting
Gustave Roussy
Villejuif, 94805
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif, 94805
FranceActive - Recruiting
Alexandra Hospital
Athens, 11528
GreeceActive - Recruiting
Metropolitan General
Athens, 15562
GreeceActive - Recruiting
Sotiria General Hospital
Athens, 11527
GreeceActive - Recruiting
University Hospital of Heraklion
Heraklion - Crete, 71500
GreeceActive - Recruiting
European Interbalkan Medical Center
Thessaloniki, 57001
GreeceActive - Recruiting
Orszagos Onkologiai Intezet
Budapest, 1122
HungaryActive - Recruiting
Semmelweis Egyetem
Budapest, 1082
HungaryActive - Recruiting
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
HungaryActive - Recruiting
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
Szolnok, 5004
HungaryActive - Recruiting
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok, 5000
HungaryActive - Recruiting
Rambam Medical Center
Haifa, 3109601
IsraelActive - Recruiting
Hadassah Ein-Kerem Medical Center
Jerusalem, 9112001
IsraelActive - Recruiting
Rabin Medical Center
Petah Tikva, 4941492
IsraelActive - Recruiting
Sheba Medical Center
Ramat Gan, 5262000
IsraelActive - Recruiting
Tel-Aviv Sourasky Medical Center
Tel Aviv, 6423906
IsraelActive - Recruiting
Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS
Candiolo TO, 10060
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti
Foggia, 71100
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
Foggia, 71100
ItalyActive - Recruiting
Azienda Unita Locale Socio Sanitaria 3 Presidio Ospedaliero di Mirano
Mirano, 30035
ItalyActive - Recruiting
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
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126
ItalyTerminated
Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara
Pisa, 56126
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
ItalyTerminated
Azienda Ospedaliera Policlinico Umberto I
Roma, 00161
ItalyActive - Recruiting
Aichi Cancer Center
Nagoya-shi, Aichi 464-8681
JapanActive - Recruiting
National Cancer Center Hospital East
Kashiwa-shi, Chiba 277-8577
JapanActive - Recruiting
Kindai University Hospital
Osakasayama-shi, Osaka 589-8511
JapanActive - Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo 104-0045
JapanActive - Recruiting
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo 135-8550
JapanActive - Recruiting
Asan Medical Center
Seoul, 138-736
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
Severance Hospital Yonsei University Health System
Seoul, 03722
Korea, Republic ofActive - Recruiting
Investigacion Onco Farmacéutica S de RL de CV
La Paz, Baja California Sur 23040
MexicoTerminated
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
MexicoActive - Recruiting
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
MexicoTerminated
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
MexicoActive - Recruiting
Christus Muguerza Clinica Vidriera
Monterrey, Nuevo León 64570
MexicoTerminated
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
NetherlandsActive - Recruiting
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA
NetherlandsActive - Recruiting
Pratia Mcm Krakow
Krakow, 30-727
PolandActive - Recruiting
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338
PolandActive - Recruiting
Ars Medical Spzoo
Pila, 64-920
PolandTerminated
Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo
Siedlce, 08-110
PolandActive - Recruiting
Centrum Medyczne Pratia Poznan
Skorzewo, 60-185
PolandTerminated
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
PortugalActive - Recruiting
Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier
Lisboa, 1440-005
PortugalTerminated
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisboa, 1649-035
PortugalActive - Recruiting
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj Napoca, 400015
RomaniaActive - Recruiting
Centrul de Oncologie Sf Nectarie SRL
Craiova, 200347
RomaniaActive - Recruiting
Institutul Regional de Oncologie Iasi
Iasi, 700483
RomaniaActive - Recruiting
SC Oncomed SRL
Timisoara, 300239
RomaniaActive - Recruiting
Hospital Clinico Universitario Virgen de la Victoria
Malaga, Andalucía 29010
SpainActive - Recruiting
Hospital Quironsalud Barcelona
Barcelona, Cataluña 08023
SpainActive - Recruiting
Hospital Universitari Vall d Hebron
Barcelona, Cataluña 08035
SpainActive - Recruiting
Next Oncology IOB Hospital Quironsalud Barcelona
Barcelona, Cataluña 08023
SpainActive - Recruiting
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Galicia 15706
SpainActive - Recruiting
Hospital General Universitario Gregorio Maranon
Madrid, 28007
SpainActive - Recruiting
Kantonsspital Graubuenden
Chur, 7000
SwitzerlandActive - Recruiting
Hopitaux Universitaires de Geneve
Geneve, 1205
SwitzerlandSite Not Available
Hopitaux Universitaires de Geneve
Geneve 14, 1205
SwitzerlandActive - Recruiting
Christie Hospital
Manchester, M20 4BX
United KingdomActive - Recruiting
The Christie Hospital
Manchester, M20 4BX
United KingdomActive - Recruiting
Weston Park Hospital
Sheffield, S10 2SJ
United KingdomActive - Recruiting
City of Hope National Medical Center
Duarte, California 91010
United StatesActive - Recruiting
University of California Irvine
Orange, California 92868
United StatesActive - Recruiting
Rocky Mountain Cancer Centers
Aurora, Colorado 80012
United StatesActive - Recruiting
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 StatesCompleted
Henry Ford Hospital
Detroit, Michigan 48202
United StatesCompleted
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee 37203
United StatesActive - Recruiting
Texas Oncology - Baylor
Dallas, Texas 75246
United StatesActive - Recruiting
Texas Oncology - Dallas Fort Worth
Dallas, Texas 75246
United StatesActive - Recruiting
Texas Oncology-Sammons
Dallas, Texas 75246
United StatesActive - Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesCompleted
US Oncology Regulatory Affairs Corporate Office
Irving, Texas 75063
United StatesActive - Recruiting
US Oncology Research Investigational Products Center
Irving, Texas 75063
United StatesActive - Recruiting
Texas Oncology Northeast Texas
Tyler, Texas 75702
United StatesActive - Recruiting
Texas Oncology-Tyler
Tyler, Texas 75702
United StatesActive - Recruiting
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