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

Last updated: April 23, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Solid Tumors

Treatment

Bemarituzumab

Clinical Study ID

NCT05325866
20210104
2023-505455-44
  • Ages 18-99
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years (or legal adult age within country, whichever is older) at the timethat the Informed Consent Form (ICF) is signed

  2. 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

  1. Disease that is unresectable, locally advanced, or metastatic (not amenable tocurative therapy)

  2. Tumor overexpresses FGFR2b as determined by centrally performed immunohistochemistry (IHC) testing

  3. Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1

  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  5. Adequate organ function as determined per protocol.

Exclusion

Exclusion Criteria:

  1. Untreated or symptomatic central nervous system (CNS) metastases or leptomeningealdisease.

  2. Other solid tumor cohort excludes primary tumors of the CNS, squamous non-small celllung cancer, gastric adenocarcinoma, and gastroesophageal junction adenocarcinoma

  3. 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

  4. History of systemic disease or ophthalmologic disorders requiring chronic use ofophthalmic steroids

  5. Evidence of any ongoing ophthalmologic abnormalities or symptoms that are acute (within 4 weeks) or actively progressing

  6. Unwillingness to avoid use of contact lenses during study treatment and for at least 100 days after the end of treatment

  7. 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

  8. Prior treatment with any investigational selective inhibitor of the fibroblastgrowth factor (FGF)/FGF receptor pathway (unless approved standard of care for tumorindication).

Study Design

Total Participants: 303
Treatment Group(s): 1
Primary Treatment: Bemarituzumab
Phase: 1/2
Study Start date:
September 23, 2022
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Instituto Alexander Fleming

    Capital Federal, Buenos Aires C1426ANZ
    Argentina

    Active - Recruiting

  • Fundacion Cenit Para La Investigacion

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1125ABD
    Argentina

    Active - Recruiting

  • Hospital Aleman

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1118AAT
    Argentina

    Active - Recruiting

  • Hospital Italiano de La Plata

    La Plata, Buenos Aires 1900
    Argentina

    Active - Recruiting

  • Sociedad de Beneficencia Hospital Italiano

    Cordoba, Córdoba 5000
    Argentina

    Active - Recruiting

  • Fundacion Medica de Rio Negro y Neuquen

    Cipolletti, Río Negro 8324
    Argentina

    Active - Recruiting

  • Centro Oncologico Korben

    Buenos Aires, 1426
    Argentina

    Active - Recruiting

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • Prince of Wales Hospital

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Wollongong Hospital

    Wollongong, New South Wales 2500
    Australia

    Active - Recruiting

  • Toowoomba Hospital

    Toowoomba, Queensland 4350
    Australia

    Terminated

  • Cabrini Hospital

    Malvern, Victoria 3144
    Australia

    Terminated

  • St John of God Murdoch Hospital

    Murdoch, Western Australia 6150
    Australia

    Active - Recruiting

  • Medizinische Universitaet Graz

    Graz, 8036
    Austria

    Active - Recruiting

  • Landeskrankenhaus Salzburg

    Salzburg, 5020
    Austria

    Completed

  • Universitaetsklinikum Salzburg

    Salzburg, 5020
    Austria

    Active - Recruiting

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Bruxelles, 1200
    Belgium

    Active - Recruiting

  • Grand Hopital de Charleroi

    Charleroi, 5530
    Belgium

    Active - Recruiting

  • Grand Hopital de Charleroi - Site des Viviers

    Charleroi, 6060
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • Grand Hopital de Charleroi - Site des Viviers

    Gilly, 6060
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Hospital das Clinicas da Ufmg

    Belo Horizonte, Minas Gerais 30130-100
    Brazil

    Active - Recruiting

  • Centro de Oncologia Mackenzie

    Curitiba, Paraná 80440-220
    Brazil

    Active - Recruiting

  • Associacao Hospitalar Moinhos de Vento

    Porto Alegre, Rio Grande Do Sul 90035-001
    Brazil

    Active - Recruiting

  • Beneficencia Portuguesa de Sao Paulo

    Sao Paulo, São Paulo 01323-900
    Brazil

    Active - Recruiting

  • Beneficencia Portuguesa de Sao Paulo - Bp

    Sao Paulo, São Paulo 01323-900
    Brazil

    Active - Recruiting

  • Instituto do Cancer Arnaldo Vieira de Carvalho

    Sao Paulo, São Paulo 01221-020
    Brazil

    Active - Recruiting

  • Oncologia Rede D Or

    Sao Paulo, São Paulo 04501-000
    Brazil

    Active - Recruiting

  • Oncologia Rede D´Or

    Sao Paulo, São Paulo 04501-000
    Brazil

    Active - Recruiting

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22250-905
    Brazil

    Active - Recruiting

  • Complex Oncology Center Plovdiv EOOD

    Plovdiv, 4004
    Bulgaria

    Active - Recruiting

  • Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

    Plovdiv, 4000
    Bulgaria

    Active - Recruiting

  • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

    Sofia, 1606
    Bulgaria

    Active - Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Active - Recruiting

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 1Z5
    Canada

    Active - Recruiting

  • Masarykuv onkologicky ustav

    Brno, 656 53
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Kralove, 500 05
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Kralovske Vinohrady

    Praha 10, 100 34
    Czechia

    Completed

  • Rigshospitalet

    Kobenhavn O, 2100
    Denmark

    Active - Recruiting

  • Docrates Syopasairaala

    Helsinki, 00180
    Finland

    Active - Recruiting

  • Tampere University Hospital

    Tampere, 33521
    Finland

    Active - Recruiting

  • Tampere University Hospital TAYS

    Tampere, 33521
    Finland

    Active - Recruiting

  • Institut de Cancerologie de l Ouest Rene Gauducheau

    Angers Cedex 02, 49055
    France

    Active - Recruiting

  • Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz

    Besancon, 25030
    France

    Active - Recruiting

  • Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz

    Besancon cedex, 25030
    France

    Site Not Available

  • Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz

    Besancon cedex, 25030
    France

    Active - Recruiting

  • Centre Oscar Lambret

    Lille Cedex, 59020
    France

    Active - Recruiting

  • Institut Paoli Calmettes

    Marseille Cedex 09, 13272
    France

    Active - Recruiting

  • Institut regional du Cancer Montpellier

    Montpellier Cedex 5, 34298
    France

    Active - Recruiting

  • Centre Hospitalier Lyon Sud

    Pierre-Benite, 69495
    France

    Active - Recruiting

  • Hopital Lyon sud

    Pierre-Benite, 69495
    France

    Active - Recruiting

  • Institut Claudius Regaud

    Toulouse cedex 9, 31059
    France

    Active - Recruiting

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse cedex 9, 31059
    France

    Active - Recruiting

  • Gustave Roussy

    Villejuif, 94805
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Active - Recruiting

  • Alexandra Hospital

    Athens, 11528
    Greece

    Active - Recruiting

  • Metropolitan General

    Athens, 15562
    Greece

    Active - Recruiting

  • Sotiria General Hospital

    Athens, 11527
    Greece

    Active - Recruiting

  • University Hospital of Heraklion

    Heraklion - Crete, 71500
    Greece

    Active - Recruiting

  • European Interbalkan Medical Center

    Thessaloniki, 57001
    Greece

    Active - Recruiting

  • Orszagos Onkologiai Intezet

    Budapest, 1122
    Hungary

    Active - Recruiting

  • Semmelweis Egyetem

    Budapest, 1082
    Hungary

    Active - Recruiting

  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Oktatokorhaz

    Nyiregyhaza, 4400
    Hungary

    Active - Recruiting

  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz

    Nyiregyhaza, 4400
    Hungary

    Active - Recruiting

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet

    Szolnok, 5004
    Hungary

    Active - Recruiting

  • Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet

    Szolnok, 5000
    Hungary

    Active - Recruiting

  • Rambam Medical Center

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Hadassah Ein-Kerem Medical Center

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan, 5262000
    Israel

    Active - Recruiting

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS

    Candiolo TO, 10060
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Ospedali Riuniti

    Foggia, 71100
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

    Foggia, 71100
    Italy

    Active - Recruiting

  • Azienda Unita Locale Socio Sanitaria 3 Presidio Ospedaliero di Mirano

    Mirano, 30035
    Italy

    Active - Recruiting

  • Azienda Unità Locale Socio Sanitaria 3 Presidio Ospedaliero di Mirano

    Mirano, 30035
    Italy

    Site Not Available

  • Azienda Unita Locale Socio Sanitaria 3 Presidio Ospedaliero di Mirano

    Mirano VE, 30035
    Italy

    Site Not Available

  • Ospedale del Mare

    Napoli, 80147
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56126
    Italy

    Terminated

  • Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara

    Pisa, 56126
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126
    Italy

    Terminated

  • Azienda Ospedaliera Policlinico Umberto I

    Roma, 00161
    Italy

    Active - Recruiting

  • Aichi Cancer Center

    Nagoya-shi, Aichi 464-8681
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba 277-8577
    Japan

    Active - Recruiting

  • Kindai University Hospital

    Osakasayama-shi, Osaka 589-8511
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo 104-0045
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo 135-8550
    Japan

    Active - Recruiting

  • Asan Medical Center

    Seoul, 138-736
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Investigacion Onco Farmacéutica S de RL de CV

    La Paz, Baja California Sur 23040
    Mexico

    Terminated

  • Investigación Onco Farmacéutica S de RL de CV

    La Paz, Baja California Sur 23040
    Mexico

    Terminated

  • Centro de Infusion e InvestigacIón Oncología de Saltillo S.C.

    Saltillo, Coahuila 25279
    Mexico

    Active - Recruiting

  • Centro de Infusion e Investigacion Oncologia de Saltillo

    Saltillo, Coahuila 25279
    Mexico

    Active - Recruiting

  • Centro de Infusion e Investigacion Oncologia de Saltillo SC

    Saltillo, Coahuila 25279
    Mexico

    Active - Recruiting

  • Investigacion Biomedica para el Desarrollo de Farmacos

    Ciudad de Mexico, Distrito Federal 03103
    Mexico

    Terminated

  • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.

    Ciudad de Mexico, Distrito Federal 03103
    Mexico

    Active - Recruiting

  • Health Pharma Professional Research SA de CV

    Mexico City, Distrito Federal 03100
    Mexico

    Active - Recruiting

  • Christus Muguerza Clinica Vidriera

    Monterrey, Nuevo León 64570
    Mexico

    Terminated

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA
    Netherlands

    Active - Recruiting

  • Pratia Mcm Krakow

    Krakow, 30-727
    Poland

    Active - Recruiting

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338
    Poland

    Active - Recruiting

  • Ars Medical Spzoo

    Pila, 64-920
    Poland

    Terminated

  • Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo

    Siedlce, 08-110
    Poland

    Active - Recruiting

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60-185
    Poland

    Terminated

  • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria

    Lisboa, 1649-035
    Portugal

    Active - Recruiting

  • Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria

    Lisboa, 1649-035
    Portugal

    Active - Recruiting

  • Centro Hospitalar de Lisboa Ocidental, EPE, Hospital Sao Francisco Xavier

    Lisboa, 1440-005
    Portugal

    Active - Recruiting

  • Hospital da Luz, SA

    Lisboa, 1500-650
    Portugal

    Active - Recruiting

  • Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier

    Lisboa, 1440-005
    Portugal

    Terminated

  • Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria

    Lisboa, 1649-035
    Portugal

    Active - Recruiting

  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

    Cluj Napoca, 400015
    Romania

    Active - Recruiting

  • Centrul de Oncologie Sf Nectarie SRL

    Craiova, 200347
    Romania

    Active - Recruiting

  • Institutul Regional de Oncologie Iasi

    Iasi, 700483
    Romania

    Active - Recruiting

  • SC Oncomed SRL

    Timisoara, 300239
    Romania

    Active - Recruiting

  • Hospital Clinico Universitario Virgen de la Victoria

    Malaga, Andalucía 29010
    Spain

    Active - Recruiting

  • Hospital Quironsalud Barcelona

    Barcelona, Cataluña 08023
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d Hebron

    Barcelona, Cataluña 08035
    Spain

    Active - Recruiting

  • Next Oncology IOB Hospital Quironsalud Barcelona

    Barcelona, Cataluña 08023
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, Galicia 15706
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Active - Recruiting

  • Kantonsspital Graubuenden

    Chur, 7000
    Switzerland

    Active - Recruiting

  • Hopitaux Universitaires de Geneve

    Geneve, 1205
    Switzerland

    Site Not Available

  • Hopitaux Universitaires de Geneve

    Geneve 14, 1205
    Switzerland

    Active - Recruiting

  • Christie Hospital

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • The Christie Hospital

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • Weston Park Hospital

    Sheffield, S10 2SJ
    United Kingdom

    Active - Recruiting

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • University of California Irvine

    Orange, California 92868
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Centers

    Aurora, Colorado 80012
    United States

    Active - Recruiting

  • US Oncology Regulatory Affairs Corporate Office

    Aurora, Colorado 80012
    United States

    Active - Recruiting

  • US Oncology Research Investigational Products Center

    Aurora, Colorado 80012
    United States

    Active - Recruiting

  • US Oncology Regulatory Affairs Corporate Office

    Denver, Colorado 80218
    United States

    Site Not Available

  • US Oncology Research Investigational Products Center

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Community Health Network

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Community Health Network MD Anderson Cancer Center - North

    Indianapolis, Indiana 46250
    United States

    Completed

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Completed

  • United States Oncology Regulatory Affairs Corporate Office

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Texas Oncology - Baylor

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • Texas Oncology - Dallas Fort Worth

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • Texas Oncology-Sammons

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Completed

  • US Oncology Regulatory Affairs Corporate Office

    Irving, Texas 75063
    United States

    Active - Recruiting

  • US Oncology Research Investigational Products Center

    Irving, Texas 75063
    United States

    Active - Recruiting

  • Texas Oncology Northeast Texas

    Tyler, Texas 75702
    United States

    Active - Recruiting

  • Texas Oncology-Tyler

    Tyler, Texas 75702
    United States

    Active - Recruiting

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