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TERMINATED
NCT05325866
PHASE1/PHASE2

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

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

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

Official title: A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors With FGFR2b Overexpression (FORTITUDE-301)

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2022-09-23

Completion Date

2026-01-28

Last Updated

2026-06-22

Healthy Volunteers

No

Conditions

Interventions

DRUG

Bemarituzumab

Intravenous (IV) infusion.

Locations (115)

City of Hope National Medical Center

Duarte, California, United States

University of California Irvine

Orange, California, United States

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

Community Health Network MD Anderson Cancer Center - North

Indianapolis, Indiana, United States

Henry Ford Hospital

Detroit, Michigan, United States

United States Oncology Regulatory Affairs Corporate Office

Nashville, Tennessee, United States

Texas Oncology - Dallas Fort Worth

Dallas, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

US Oncology Research Investigational Products Center

Irving, Texas, United States

Texas Oncology Northeast Texas

Tyler, Texas, United States

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

Liverpool Hospital

Liverpool, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Toowoomba Hospital

Toowoomba, Queensland, Australia

Cabrini Hospital

Malvern, Victoria, Australia

St John of God Murdoch Hospital

Murdoch, Western Australia, Australia

Medizinische Universitaet Graz

Graz, Austria

Landeskrankenhaus Salzburg

Salzburg, Austria

Universite Catholique de Louvain Cliniques Universitaires Saint Luc

Brussels, Belgium

Grand Hopital de Charleroi - Site des Viviers

Charleroi, Belgium

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Belgium

Hospital das Clinicas da Ufmg

Belo Horizonte, Minas Gerais, Brazil

Centro de Oncologia Mackenzie

Curitiba, Paraná, Brazil

Associacao Hospitalar Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Instituto do Cancer Arnaldo Vieira de Carvalho

São Paulo, São Paulo, Brazil

Beneficencia Portuguesa de Sao Paulo - Bp

São Paulo, São Paulo, Brazil

Oncologia Rede D Or

São Paulo, São Paulo, Brazil

Oncoclinicas Rio de Janeiro S A

Rio de Janeiro, Brazil

Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

Plovdiv, Bulgaria

Complex Oncology Center Plovdiv EOOD

Plovdiv, Bulgaria

Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

Sofia, Bulgaria

Cross Cancer Institute

Edmonton, Alberta, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Masarykuv onkologicky ustav

Brno, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Fakultni nemocnice Olomouc

Olomouc, Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

Rigshospitalet

København Ø, Denmark

Docrates Syopasairaala

Helsinki, Finland

Tampere University Hospital

Tampere, Finland

Institut de Cancerologie de l Ouest Rene Gauducheau

Angers, France

Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz

Besançon, France

Centre Oscar Lambret

Lille, France

Institut Paoli Calmettes

Marseille, France

Institut regional du Cancer Montpellier

Montpellier, France

Hopital Lyon sud

Pierre-Bénite, France

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France

Gustave Roussy

Villejuif, France

Sotiria General Hospital

Athens, Greece

Alexandra Hospital

Athens, Greece

Metropolitan General

Athens, Greece

University Hospital of Heraklion

Heraklion - Crete, Greece

European Interbalkan Medical Center

Thessaloniki, Greece

Semmelweis Egyetem

Budapest, Hungary

Orszagos Onkologiai Intezet

Budapest, Hungary

Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz

Nyíregyháza, Hungary

Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet

Szolnok, Hungary

Rambam Medical Center

Haifa, Israel

Hadassah Ein-Kerem Medical Center

Jerusalem, Israel

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS

Candiolo to, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

Foggia, Italy

Azienda Unita Locale Socio Sanitaria 3 Presidio Ospedaliero di Mirano

Mirano, Italy

Ospedale del Mare

Naples, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Azienda Ospedaliera Policlinico Umberto I

Roma, Italy

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Kindai University Hospital

Osakasayama-shi, Osaka, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, Japan

Investigacion Onco Farmacéutica S de RL de CV

La Paz, Baja California Sur, Mexico

Centro de Infusion e Investigacion Oncologia de Saltillo

Saltillo, Coahuila, Mexico

Health Pharma Professional Research SA de CV

Mexico City, Mexico City, Mexico

Investigacion Biomedica para el Desarrollo de Farmacos

Mexico City, Mexico City, Mexico

Christus Muguerza Clinica Vidriera

Monterrey, Nuevo León, Mexico

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Radboud Universitair Medisch Centrum

Nijmegen, Netherlands

Pratia Mcm Krakow

Krakow, Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, Poland

Ars Medical Spzoo

Piła, Poland

Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo

Siedlce, Poland

Centrum Medyczne Pratia Poznan

Skorzewo, Poland

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

Lisbon, Portugal

Hospital da Luz, SA

Lisbon, Portugal

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

Lisbon, Portugal

Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

Cluj-Napoca, Romania

Centrul de Oncologie Sf Nectarie SRL

Craiova, Romania

And 15 more locations on ClinicalTrials.gov