Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer

Gastric Cancer Clinical Trial

— FORTITUDE-102  

Official title:

A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05111626
• Other study ID #: 20210098
• Secondary ID: 2023-505458-16
• Status: Recruiting
• Phase: Phase 3
• Start date: March 14, 2022
• Est. completion date: September 26, 2026

Study information

• Verified date: June 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab. The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 528
• Est. completion date: September 26, 2026
• Est. primary completion date: September 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria Part 1 and Part 2:

• Adult with unresectable, locally advanced or metastatic (not amenable to curative therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)
• Participant has no contraindications to nivolumab and either mFOLFOX6 or CAPOX chemotherapy as per local prescribing information. Participants in Part 1 must have no contraindications to mFOLFOX6. Participants in Part 2 with contraindications to mFOLFOX6 are permitted and may be administered the CAPOX regimen, if no contraindications for this regimen exist. Participants in Part 2 with contraindications to CAPOX are permitted and may be administered the mFOLFOX6 regimen, if no contraindications for this regimen exist
• Adequate organ function as follows:
• Absolute neutrophil count = 1.5 x 10^9/L
• Platelet count = 100 x 10^9/L
• Hemoglobin = 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
• Aspartate aminotransaminase (AST) and Alanine aminotransaminase (ALT) <3 x upper limit of normal (ULN) (or < 5 x ULN if liver involvement)
• Total bilirubin <1.5 x ULN (or < 2 x ULN if liver involvement or Gilbert's disease)
• Part 1 only: Calculated or measured creatinine clearance (CrCl) of = 50 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age] × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female).
• Part 2 only: Calculated or measured creatinine clearance (CrCl) of = 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age] × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female).
• INR or prothrombin time (PT) < 1.5 × ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment

Additional Inclusion Criteria Part 2:

• No prior treatment for metastatic or unresectable disease except for a maximum of 1 dose of chemotherapy with or without nivolumab; prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed, provided it has been completed more than 6 months prior to the first dose of study treatment
• Fibroblast growth factor receptor 2b (FGFR2b) = 10% 2+/3+ tumor cells (TC) as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy.

Exclusion Criteria:

• Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
• Known positive human epidermal growth factor receptor 2 (HER2) status
• Untreated or symptomatic central nervous system disease metastases and leptomeningeal disease
• Peripheral sensory neuropathy grade 2 or higher
• Clinically significant cardiac disease
• Other malignancy within the last 2 years (exceptions for definitively treated disease)
• Chronic or systemic ophthalmologic disorders
• Major surgery or other investigational study within 28 days prior to randomization
• Palliative radiotherapy within 14 days prior to randomization
• Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
• Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma
• Stomach Neoplasms

Intervention

Drug:
• Bemarituzumab
Bemarituzumab will be administered as intravenous (IV) infusion.
• Nivolumab
Nivolumab will be administered as IV infusion.
• Chemotherapy
mFOLFOX6: 5-fluorouracil, leucovorin, and oxaliplatin will be administered as IV infusion. OR CAPOX: oxaliplatin will be administered as IV infusion and capecitabine will be administered orally.

Other:
• Placebo
Placebo will be administered as IV infusion.

Locations

Country	Name	City	State
Argentina	Fundacion Respirar	Buenos Aires
Argentina	Hospital Italiano	Capital Federal
Argentina	Cemic	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Centro Medico Austral	Ciudad Autónoma de Buenos Aires	Distrito Federal
Argentina	Hospital Privado Universitario de Cordoba	Córdoba
Argentina	Sanatorio Allende	Córdoba
Argentina	Hospital Italiano de La Plata	La Plata	Buenos Aires
Argentina	Centro Oncologico Riojano Integral	La Rioja
Argentina	Exelsus Oncologia Clinica	San Miguel de Tucuman	Tucuman
Argentina	Fundacion Ars Medica	San Salvador de Jujuy	Jujuy
Argentina	Clinica Viedma	Viedma	Río Negro
Australia	Ballarat Health Services	Ballarat	Victoria
Australia	Austin Health, Austin Hospital	Heidelberg	Victoria
Australia	GenesisCare -North Shore Oncology	St Leonards	New South Wales
Australia	Calvary Mater Newcastle Hospital	Waratah	New South Wales
Australia	The Queen Elizabeth Hospital	Woodville South	South Australia
Austria	Medizinische Universitaet Graz	Graz
Austria	Medizinische Universitaet Innsbruck	Innsbruck
Austria	Landeskrankenhaus Feldkirch	Rankweil
Austria	Landeskrankenhaus Salzburg	Salzburg
Austria	Universitaetsklinikum Allgemeines Krankenhaus Wien	Wien
Austria	Krankenhaus Wiener Neustadt	Wiener Neustadt
Belgium	Institut Jules Bordet	Brussels
Belgium	Universite Catholique de Louvain Cliniques Universitaires Saint Luc	Bruxelles
Belgium	Grand Hopital de Charleroi	Charleroi
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Universitair Ziekenhuis Brussel	Jette
Belgium	Universitair Ziekenhuis Leuven - Campus Gasthuisberg	Leuven
Belgium	Hopital De Libramont	Libramont
Belgium	Centre Hospitalier Universitaire de Liege - Sart Tilman	Liege
Belgium	Algemeen Ziekenhuis Turnhout Campus Sint-Jozef	Turnhout
Brazil	Fundacao Pio 12 Hospital de Amor de Barretos	Barretos	São Paulo
Brazil	Personal Oncologia de Precisao e Personalizada	Belo Horizonte	Minas Gerais
Brazil	Hospital Sirio Libanes	Brasilia	Distrito Federal
Brazil	Hospital Evangelico de Cachoeiro de Itapemirim	Cachoeiro de Itapemirim	Espírito Santo
Brazil	Hospital Haroldo Juacaba - Instituto do Cancer do Ceara	Fortaleza	Ceará
Brazil	Liga Norte-Riograndense Contra O Cancer	Natal	Rio Grande Do Norte
Brazil	Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital das Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto Coi	Rio de Janeiro
Brazil	Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto	São José do Rio Preto	São Paulo
Brazil	Fundacao Antonio Prudente AC Camargo Cancer Center	Sao Paulo	São Paulo
Brazil	Instituto do Cancer Arnaldo Vieira de Carvalho	Sao Paulo	São Paulo
Brazil	Sociedade Beneficente de Senhoras Hospital Sirio Libanes	Sao Paulo	São Paulo
Brazil	Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp	São Paulo
Bulgaria	Complex Oncology Center - Burgas	Burgas
Bulgaria	Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD	Haskovo
Bulgaria	Multiprofile Hospital for Active Treatment - Uni Hospital OOD	Panagyurishte
Bulgaria	Multiprofile Hospital for Active Treatment Central Onco Hospital OOD	Plovdiv
Bulgaria	Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia	Sofia
Bulgaria	Multiprofile Hospital for Active Treatment Serdika EOOD	Sofia
Canada	London Health Sciences Centre	London	Ontario
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Centre Hospitalier de L Universite de Montreal	Montréal	Quebec
Canada	CHU de Quebec Hopital de l Enfant Jesus	Quebec
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Sunnybrook Research Institute Sunnybrook Health Sciences Centre	Toronto	Ontario
Chile	IC La Serena Research	La Serena
Chile	Centro de Estudios Clinicos e Investigaciones Medicas CeCim	Santiago
Chile	Centro de Estudios Clinicos SAGA Spa	Santiago
Chile	Icegclinic	Santiago
Chile	Oncovida	Santiago
Chile	Centro De Estudios Clínicos Suecia SpA	Santiago de Chile	Santiago
Chile	Oncocentro Apys	Viña del Mar	Valparaíso
China	Cancer Hospital of Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	China-Japan Union Hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	The Second Xiangya Hospital of Central South Universiy	Changsha	Hunan
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	Changzhi Peoples Hospital	Changzhi	Shanxi
China	The First People's Hospital of Changzhou	Changzhou	Jiangsu
China	Sichuan Cancer Hospital	Chengdu	Sichuan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The first people's Hospital of Foshan	Foshan	Guangdong
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Guangdong Provincial Peoples Hospital	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital of Hainan Medical University	Haikou	Hainan
China	Sir Run Run Shaw Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Provincial Cancer Hospital	Hefei	Anhui
China	Inner Mongolia Autonomous Region Peoples Hospital	Hohhot	Inner Mongolia
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	The Affiliated Cancer Hospital of Shandong First Medical University	Jinan	Shandong
China	Affiliated Hospital of Jining Medical University	Jining	Shandong
China	Yunnan Cancer Hospital	Kunming	Yunnan
China	Gansu Provincial Cancer Hospital	Lanzhou	Gansu
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	Linfen Central Hospital	Linfen	Shanxi
China	Taizhou Hospital of Zhejiang Province	Linhai	Zhejiang
China	Lishui Municipal central Hospital	Lishui	Zhejiang
China	The First Affiliated Hospital of Henan University of science and Technology	Luoyang	Henan
China	The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Guangxi Medical University Cancer Hospital	Nanning	Guangxi
China	The First Affiliate Hospital of Ningbo University	Ningbo	Zhejiang
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Ruijin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai East Hospital	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai
China	Cancer Hospital of Shantou University Medical College	Shantou	Guangdong
China	Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Taihe Hospital Affiliated Hospital of Hubei University of Medicine	Shiyan	Hubei
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Hubei Cancer Hospital	Wuhan	Hubei
China	The Cancer Center Union Hospital Tongji Medical College Huazhong University of Science and Tech	Wuhan	Hubei
China	Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of ScienceandTechnology	Wuhan	Hebei
China	Gansu Wuwei Tumour Hospital	Wuwei	Gansu
China	Affiliated Hospital of Jiangnan University	Wuxi	Jiangsu
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Shaanxi Provincial Peoples Hospital	Xian	Shaanxi
China	The First Affiliated Hospital of Xian Jiaotong University	Xian	Shaanxi
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Affiliated Hospital of Yangzhou University	Yangzhou	Jiangsu
China	Northern Jiangsu Peoples Hospital	Yangzhou	Jiangsu
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
Colombia	Fundacion Cardiovascular de Colombia	Bucaramanga	Santander
Colombia	Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA	Rionegro	Antioquia
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Czechia	Fakultni Thomayerova nemocnice	Praha 4
France	Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud	Amiens Cedex 1
France	Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz	Besançon
France	Institut Bergonie	Bordeaux
France	Centre Hospitalier Universitaire de Brest - Cavale Blanche	Brest Cedex
France	Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital Estaing	Clermont-Ferrand cedex 1
France	Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez	Lille
France	Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren	Limoges Cedex
France	Centre Leon Berard	Lyon cedex 8
France	Centre Antoine Lacassagne	Nice
France	Hôpital Européen Georges Pompidou	Paris
France	Hôpital Saint Louis	Paris Cedex 10
France	Institut Mutualiste Montsouris	Paris Cedex 14
France	Centre Hospitalier Universitaire de Rouen	Rouen Cedex
France	Centre Rene Gauducheau - Institut de Cancerologie de l Ouest	Saint Herblain
France	Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord	Saint Priest en Jarez
France	Institut de cancerologie Strasbourg Europe	Strasbourg cedex
France	Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil	Toulouse Cedex 9
France	Institut Gustave Roussy	Villejuif
Germany	Charite - Universitaetsmedizin Berlin, Campus Virchow	Berlin
Germany	Universitaetsklinikum Dresden	Dresden
Germany	Krankenhaus Nordwest GmbH	Frankfurt am Main
Germany	Haematologisch Onkologische Praxis Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitaetsklinikum Schleswig-Holstein	Kiel
Germany	Universitaetsklinikum Leipzig	Leipzig
Germany	Regional Kliniken Holding Klinikum Ludwigsburg	Ludwigsburg
Germany	Johannes Gutenberg Universitaet Mainz	Mainz
Germany	Universitaetsmedizin Mannheim	Mannheim
Germany	Klinikum der LMU Muenchen	Muenchen
Germany	Klinikum rechts der Isar der TUM	Muenchen
Germany	Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen	Tuebingen
Germany	Universitaetsklinikum Ulm	Ulm
Germany	Klinikum der Stadt Wolfsburg	Wolfsburg
Hong Kong	Prince of Wales Hospital	Shatin, New Territories
Hungary	Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet	Budapest
Hungary	Orszagos Onkologiai Intezet	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz	Nyiregyhaza
Hungary	Tolna Varmegyei Balassa Janos Korhaz	Szekszard
Hungary	Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet	Szolnok
Hungary	Komarom-Esztergom Varmegyei Szent Borbala Korhaz	Tatabanya
Israel	Rambam Health Care Campus	Haifa
Israel	Hadassah Ein-Kerem Medical Center	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Sheba Medical Center	Ramat Gan
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona	Ancona
Italy	Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii	Bergamo
Italy	Ente Ospedaliero IRCCS Saverio De Bellis	Castellana Grotte
Italy	Azienda Socio Sanitaria Territoriale di Cremona	Cremona
Italy	Azienda Ospedaliero Universitaria Careggi	Firenze
Italy	Ospedale Policlinico San Martino IRCCS	Genova
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano
Italy	IRCCS Ospedale San Raffaele	Milano
Italy	Azienda Ospedaliero Universitaria Luigi Vanvitelli	Napoli
Italy	Istituto Oncologico Veneto IRCCS	Padova
Italy	Azienda Ospedaliera Universitaria Pisana	Pisa
Japan	Hyogo Cancer Center	Akashi-shi	Hyogo
Japan	Chiba Cancer Center	Chiba-shi	Chiba
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka-shi	Fukuoka
Japan	Gifu University Hospital	Gifu-shi	Gifu
Japan	Kansai Medical University Hospital	Hirakata-shi	Osaka
Japan	National Cancer Center Hospital East	Kashiwa-shi	Chiba
Japan	Saitama Cancer Center	Kitaadachi-gun	Saitama
Japan	Kobe City Medical Center General Hospital	Kobe-shi	Hyogo
Japan	The Cancer Institute Hospital of Japanese Foundation for Cancer Research	Koto-ku	Tokyo
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama-shi	Ehime
Japan	Nagoya University Hospital	Nagoya-shi	Aichi
Japan	Niigata Cancer Center Hospital	Niigata-shi	Niigata
Japan	Osaka International Cancer Institute	Osaka-shi	Osaka
Japan	Kindai University Hospital	Osakasayama-shi	Osaka
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Osaka University Hospital	Suita-shi	Osaka
Japan	Shizuoka Cancer Center	Sunto-gun	Shizuoka
Japan	Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center	Yokohama-shi	Kanagawa
Japan	Yokohama City University Medical Center	Yokohama-shi	Kanagawa
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	National Cancer Center	Goyang-si Gyeonggi-do
Korea, Republic of	Jeonbuk National University Hospital	Jeonju-si, Jeollabuk-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si, Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St Marys Hospital	Seoul
Poland	Beskidzkie Centrum Onkologii Szpital Miejski imienia Jana Pawla Drugiego	Bielsko-Biala
Poland	Narodowy Instytut Onkologii im M Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwicach	Gliwice
Poland	Przychodnia Lekarska Komed Roman Karaszewski	Konin
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1	Lublin
Poland	Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji	Olsztyn
Poland	Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo	Siedlce
Poland	Centrum Medyczne Pratia Poznan	Skorzewo
Poland	Uniwersytecki Szpital Kliniczny nr 1 im prof Tadeusza Sokolowskiego Pum w Szczecinie	Szczecin
Poland	Lux med onkologia sp zoo szpital szamocka	Warszawa
Poland	Mtz Clinical Research powered by Pratia	Warszawa
Poland	Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy	Warszawa
Poland	Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu	Wroclaw
Portugal	Unidade Local de Saude de Braga, EPE	Braga
Portugal	Unidade Local de Saude do Alto Ave, EPE	Guimaraes
Portugal	Hospital da Luz, SA	Lisboa
Portugal	Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria	Lisboa
Portugal	Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano	Matosinhos
Portugal	Hospital Cuf porto	Porto
Portugal	Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE	Porto
Portugal	Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao	Porto
Romania	Institutul Clinic Fundeni	Bucharest
Romania	Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca	Cluj Napoca
Romania	Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor	Cluj-Napoca
Romania	Centrul de Oncologie Sf Nectarie SRL	Craiova
Romania	Institutul Regional de Oncologie Iasi	Iasi
Romania	SC Oncomed SRL	Timisoara
Singapore	National Cancer Centre Singapore	Singapore
Singapore	National University Hospital	Singapore
Spain	Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera	A Coruña	Galicia
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona	Cataluña
Spain	Hospital del Mar	Barcelona	Cataluña
Spain	Hospital Universitari Vall d Hebron	Barcelona	Cataluña
Spain	Hospital General Universitario de Elche	Elche	Comunidad Valenciana
Spain	Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals	Hospitalet de Llobregat	Cataluña
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Universitario de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	Hospital Universitario Virgen del Rocio	Sevilla	Andalucía
Spain	Hospital Clinico Universitario de Valencia	Valencia	Comunidad Valenciana
Spain	Hospital General Universitario de Valencia	Valencia	Comunidad Valenciana
Switzerland	Universitaetsspital Basel	Basel
Switzerland	Inselspital Bern	Bern
Switzerland	Kantonsspital Graubuenden	Chur
Switzerland	Hopitaux Universitaires de Geneve	Geneve
Switzerland	Onkozentrum Zuerich	Zurich
Switzerland	Universitaetsspital Zuerich	Zurich
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Thailand	Chulabhorn Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital	Chiang Mai
Thailand	Chiangrai Prachanukroh Hospital	Chiang Rai
Thailand	Prince of Songkla Hospital	Songkhla
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	University Hospital Coventry	Coventry
United Kingdom	Ninewells Hospital and Medical School	Dundee
United Kingdom	Guys Hospital	London
United Kingdom	Christie Hospital	Manchester
United Kingdom	Mount Vernon Cancer Centre	Northwood
United Kingdom	Churchill Hospital	Oxford
United Kingdom	Torbay Hospital	Torquay
United States	Saint Lukes University Health Network	Allentown	Pennsylvania
United States	Texas Oncology - Austin Midtown	Austin	Texas
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Gabrail Cancer Center, LLC	Canton	Ohio
United States	The Oncology Institute Clinical Research	Cerritos	California
United States	Medical University of South Carolina, Hollings Cancer Center	Charleston	South Carolina
United States	University of Illinois Hospital and Health Sciences System	Chicago	Illinois
United States	Henry Ford Health System	Detroit	Michigan
United States	Cancer and Blood Specialty Clinic	Downey	California
United States	City of Hope National Medical Center	Duarte	California
United States	Summit Medical Group	Florham Park	New Jersey
United States	Florida Cancer Specialists - Fort Myers	Fort Myers	Florida
United States	The West Clinic, PLLC	Germantown	Tennessee
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	University of California Los Angeles	Los Angeles	California
United States	Aurora Health Care Metro Inc	Milwaukee	Wisconsin
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Yale New Haven Hospital Yale Cancer Center	New Haven	Connecticut
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	University of California Irvine	Orange	California
United States	Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando	Orlando	Florida
United States	Orlando Health Cancer Institute	Orlando	Florida
United States	Mayo Clinic - Arizona	Phoenix	Arizona
United States	FirstHealth Cancer Center	Pinehurst	North Carolina
United States	Providence Portland Medical Center	Portland	Oregon
United States	Torrance Memorial Physician Network	Redondo Beach	California
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Translational Research in Oncology - US Inc	Santa Monica	California
United States	Translational Research in Oncology US Inc, Trio Central Pharmacy	Santa Monica	California
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Olive View-University of California in Los Angeles Medical Center	Sylmar	California
United States	United States Oncology Regulatory Affairs Corporate Office	The Woodlands	Texas
United States	US Oncology Research Investigational Products Center	The Woodlands	Texas
United States	Northwest Cancer Specialists - Vancouver	Vancouver	Washington
United States	Presbyterian Intercommunity Hospital Health Whitter Hospital	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Czechia,  France,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Poland,  Portugal,  Romania,  Singapore,  Spain,  Switzerland,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Number of Participants Who Experienced DLTs		28 days
Primary	Part 1: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)		Up to 4.5 years
Primary	Part 1: Number of Participants Who Experienced One or More Related TEAEs		Up to 4.5 years
Primary	Part 1: Number of Participants With Clinically Significant Changes in Vital Signs		Up to 4.5 years
Primary	Part 1: Number of Participants With Clinically Significant Changes in Visual Acuity		Up to 4.5 years
Primary	Part 1: Number of Participants With Clinically Significant Changes in Physical Examinations		Up to 4.5 years
Primary	Part 1: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests		Up to 4.5 years
Primary	Part 2: Overall Survival in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants		Up to 4.5 years
Secondary	Part 1: Objective Response (OR)		Up to 4.5 years
Secondary	Part 1: Duration of Response (DoR)		Up to 4.5 years
Secondary	Part 1: Disease Control Rate (DCR)		Up to 4.5 years
Secondary	Part 1: Progression Free Survival (PFS)		Up to 4.5 years
Secondary	Part 1: Overall Survival		Up to 4.5 years
Secondary	Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab		Day 1 to up to 4.5 years
Secondary	Part 1: Area Under the Concentration Time Curve (AUC) of Bemarituzumab		Day 1 to up to 4.5 years
Secondary	Part 1: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab		Day 1 to up to 4.5 years
Secondary	Part 1: Number of Participants With Anti-Bemarituzumab Antibody Formation		Day 1 to up to 4.5 years
Secondary	Part 2: PFS in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants		Up to 4.5 years
Secondary	Part 2: OR in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants		Up to 4.5 years
Secondary	Part 2: Number of Participants Who Experienced One or More TEAEs		Up to 4.5 years
Secondary	Part 2: Number of Participants With Clinically Significant Changes in Vital Signs		Up to 4.5 years
Secondary	Part 2: Number of Participants With Clinically Significant Changes in Visual Acuity		Up to 4.5 years
Secondary	Part 2: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests		Up to 4.5 years
Secondary	Part 2: Overall Survival in All Randomized Participants		Up to 4.5 years
Secondary	Part 2: PFS in All Randomized Participants		Up to 4.5 years
Secondary	Part 2: Objective Response Rate (ORR) in All Randomized Participants		Up to 4.5 years
Secondary	Part 2: DoR in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants		Up to 4.5 years
Secondary	Part 2: DCR in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants		Up to 4.5 years
Secondary	Part 2: Mean Score in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Version 3.0 (QLQ-C30) Individual Scores in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants		Up to 4.5 years
Secondary	Part 2: Change From Baseline in EORTC QLQ-C30 Individual Scores in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants		Baseline to up to 4.5 years
Secondary	Part 2: Mean Score in Stomach Cancer Related Symptoms Measured by EORTC Quality of Life Questionnaire-Stomach 22 (QLQ-STO22) in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants		Up to 4.5 years
Secondary	Part 2: Change From Baseline in Stomach Cancer Related Symptoms Measured by EORTC QLQ-STO22 in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants		Baseline to up to 4.5 years
Secondary	Part 2: Mean Score of Visual Analogue Scale (VAS) Scores as Measured by EuroQol 5-dimensional (EQ-5D-5L) in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants		Up to 4.5 years
Secondary	Part 2: Change From Baseline of VAS Scores as Measured by EQ-5D-5L in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants		Baseline to up to 4.5 years
Secondary	Part 2: Time to Deterioration in Stomach Cancer Related Symptoms Measured by EORTC QLQ-STO22 in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants		Day 1 to up to 4.5 years
Secondary	Part 2: Time to Deterioration in Health-Related Quality of Life (HRQoL) Scores in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants		Day 1 to up to 4.5 years
Secondary	Part 2: Time to Deterioration in Physical Function Scores in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants		Day 1 to up to 4.5 years
Secondary	Part 2: Cmax of Bemarituzumab		Day 1 to up to 4.5 years
Secondary	Part 2: Ctrough of Bemarituzumab		Day 1 to up to 4.5 years
Secondary	Part 2: Number of Participants With Anti-Bemarituzumab Antibody Formation		Day 1 to up to 4.5 years

External Links

•   AmgenTrials clinical trials website