AzTrials
AzTrials

Gastric CancerPhase 3FORTITUDE-102NCT05111626

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

A Phase 3 study testing Bemarituzumab, Nivolumab and Chemotherapy in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Amgen at 348 sites in 29 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Bemarituzumab, Nivolumab and Chemotherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
515 participants
Where
348 sitesin 29 countries
Study dates
14 Mar 2022to 29 Oct 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

348 sites in 29 countries.

348 sites in 29 countries

China68 sites

  • Cancer Hospital of Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100032

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui, 233099

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130022

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Changzhi Peoples Hospital

    Changzhi, Shanxi, 046000

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213003

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400042

  • The first people's Hospital of Foshan

    Foshan, Guangdong, 528000

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510030

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510180

  • The First Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, 570102

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230031

  • Inner Mongolia Autonomous Region Peoples Hospital

    Hohhot, Inner Mongolia, 010017

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250011

  • The Affiliated Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272007

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650106

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu, 730050

  • Linfen Central Hospital

    Linfen, Shanxi, 100032

  • Taizhou Hospital of Zhejiang Province

    Linhai, Zhejiang, 317000

  • Lishui Municipal central Hospital

    Lishui, Zhejiang, 323000

  • The First Affiliated Hospital of Henan University of science and Technology

    Luoyang, Henan, 471000

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530021

  • The First Affiliate Hospital of Ningbo University

    Ningbo, Zhejiang, 315010

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

  • Ruijin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200123

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515031

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110042

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

  • Taihe Hospital Affiliated Hospital of Hubei University of Medicine

    Shiyan, Hubei, 442000

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

  • Tianjin Medical University Cancer institute and hospital

    Tianjin, Tianjin Municipality, 300060

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

  • Tongji Hospital Tongji Medical College Of Hust

    Wuhan, Hubei, 430030

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • Gansu Wuwei Tumour Hospital

    Wuwei, Gansu, 733000

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu, 214122

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710061

  • Shaanxi Provincial People Hospital

    Xi'an, Shaanxi, 710068

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221002

  • Affiliated Hospital of Yangzhou University

    Yangzhou, Jiangsu, 225001

  • Northern Jiangsu Peoples Hospital

    Yangzhou, Jiangsu, 225001

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

United States37 sites

  • Saint Lukes University Health Network

    Allentown, Pennsylvania, 18104

  • Texas Oncology Central-South

    Austin, Texas, 78705

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Gabrail Cancer Center, LLC

    Canton, Ohio, 44718

  • The Oncology Institute Clinical Research

    Cerritos, California, 90703

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Illinois Chicago

    Chicago, Illinois, 60612

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Cancer and Blood Specialty Clinic

    Downey, California, 90241

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Summit Medical Group

    Florham Park, New Jersey, 07932

  • Florida Cancer Specialists - Fort Myers

    Fort Myers, Florida, 33901

  • West Cancer Center

    Germantown, Tennessee, 38138

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Aurora Health Care Metro Inc

    Milwaukee, Wisconsin, 53215

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Yale New Haven Hospital Yale Cancer Center

    New Haven, Connecticut, 06520

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10022

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • University of California Irvine

    Orange, California, 92868

  • Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando

    Orlando, Florida, 32804

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • Mayo Clinic - Arizona

    Phoenix, Arizona, 85054

  • FirstHealth Cancer Center

    Pinehurst, North Carolina, 28374

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213

  • Torrance Memorial Physician Network

    Redondo Beach, California, 90277

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Translational Research in Oncology - US Inc

    Santa Monica, California, 90404

  • Translational Research in Oncology US Inc, Trio Central Pharmacy

    Santa Monica, California, 90404

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794-7263

  • Olive View-University of California in Los Angeles Medical Center

    Sylmar, California, 91342

  • United States Oncology Regulatory Affairs Corporate Office

    The Woodlands, Texas, 77380

  • US Oncology Research Investigational Products Center

    The Woodlands, Texas, 77380

  • Northwest Cancer Specialists - Vancouver

    Vancouver, Washington, 98684

  • Presbyterian Intercommunity Hospital Health Whitter Hospital

    Whittier, California, 90602

Other trials in United States

Japan20 sites

  • Hyogo Cancer Center

    Akashi-shi, Hyōgo, 673-8558

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Gifu University Hospital

    Gifu, Gifu, 501-1194

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka, 573-1191

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

  • Saitama Cancer Center

    Kitaadachi-gun, Saitama, 362-0806

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Osaka University Hospital

    Suita-shi, Osaka, 565-0871

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

  • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

France19 sites

  • Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud

    Amiens, 80054

  • Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz

    Besançon, 25030

  • Institut Bergonie

    Bordeaux, 33000

  • Centre Hospitalier Universitaire de Brest - Cavale Blanche

    Brest, 29609

  • Centre Hospitalier Universitaire de Clermont Ferrand, Hopital Estaing

    Clermont-Ferrand, 63003

  • Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

    Lille, 59037

  • Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren

    Limoges, 87042

  • Centre Leon Berard

    Lyon, 69373

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hopital Saint Louis

    Paris, 75475

  • Institut Mutualiste Montsouris

    Paris, 75674

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes, 35033

  • Centre Hospitalier Universitaire de Rouen

    Rouen, 76031

  • Centre Rene Gauducheau - Institut de Cancerologie de l Ouest

    Saint-Herblain, 44800

  • Centre Hospitalier Universitaire Nord de Saint Etienne - Hopital Nord

    Saint-Priest-en-Jarez, 42270

  • Institut de cancerologie Strasbourg Europe

    Strasbourg, 67065

  • Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Spain16 sites

  • Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera

    A Coruña, Galicia, 15006

  • Hospital del Mar

    Barcelona, Catalonia, 08003

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Catalonia, 08036

  • Hospital General Universitario de Elche

    Elche, Valencia, 03203

  • Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Catalonia, 08908

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, Valencia, 46010

  • Hospital General Universitario de Valencia

    Valencia, Valencia, 46014

Other trials in Spain

Germany15 sites

  • Charite - Universitaetsmedizin Berlin, Campus Virchow

    Berlin, 13353

  • Universitaetsklinikum Dresden

    Dresden, 01307

  • Krankenhaus Nordwest GmbH

    Frankfurt am Main, 60488

  • Haematologisch Onkologische Praxis Eppendorf

    Hamburg, 20249

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitaetsklinikum Schleswig-Holstein

    Kiel, 24105

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

  • Regional Kliniken Holding Klinikum Ludwigsburg

    Ludwigsburg, 71640

  • Johannes Gutenberg Universitaet Mainz

    Mainz, 55131

  • Universitaetsmedizin Mannheim

    Mannheim, 68167

  • Klinikum der LMU Muenchen

    München, 81377

  • Klinikum rechts der Isar der TUM

    München, 81675

  • Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen

    Tübingen, 72076

  • Universitaetsklinikum Ulm

    Ulm, 89081

  • Klinikum der Stadt Wolfsburg

    Wolfsburg, 38440

Other trials in Germany

Brazil14 sites

  • Fundacao Pio 12 Hospital de Amor de Barretos

    Barretos, São Paulo, 14784-400

  • Personal Oncologia de Precisao e Personalizada

    Belo Horizonte, Minas Gerais, 30130-090

  • Hospital Sirio Libanes

    Brasília, Federal District, 70200-730

  • Hospital Evangelico de Cachoeiro de Itapemirim

    Cachoeiro de Itapemirim, Espírito Santo, 29308-014

  • Hospital Haroldo Juacaba - Instituto do Cancer do Ceara

    Fortaleza, Ceará, 60430-230

  • Liga Norte-Riograndense Contra O Cancer

    Natal, Rio Grande do Norte, 59075-740

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Instituto Coi

    Rio de Janeiro, 22793-080

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • Instituto do Cancer Arnaldo Vieira de Carvalho

    São Paulo, São Paulo, 01221-020

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, São Paulo, 01308-050

  • Fundacao Antonio Prudente AC Camargo Cancer Center

    São Paulo, São Paulo, 01508-010

  • Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp

    São Paulo, 04501-000

Other trials in Brazil

Italy14 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

    Ancona, 60126

  • Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii

    Bergamo, 24127

  • Istituto Ospedaliero Fondazione Poliambulanza

    Brescia, 25124

  • Ente Ospedaliero IRCCS Saverio De Bellis

    Castellana Grotte, 70013

  • Azienda Socio Sanitaria Territoriale di Cremona

    Cremona, 26100

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Azienda Ospedaliero Universitaria Luigi Vanvitelli

    Naples, 80131

  • Istituto Nazionale dei Tumori IRCCS Fondazione Giovanni Pascale

    Naples, 80131

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56126

Other trials in Italy

South Korea13 sites

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Chungnam National University Hospital

    Daejeon, 35015

  • National Cancer Center

    Goyang-si Gyeonggi-do, 10408

  • Jeonbuk National University Hospital

    Jeonju-si, Jeollabuk-do, 54907

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

Argentina12 sites

  • Centro Medico Austral

    Buenos Aires, Distrito Federal, C1019ABS

  • Fundacion Respirar

    Buenos Aires, C1426ABP

  • Hospital Italiano

    Capital Federal, C1199ABB

  • Cemic

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO

  • Sanatorio Allende

    Córdoba, X5000JHQ

  • Hospital Privado Universitario de Cordoba

    Córdoba, X5016KEH

  • Hospital Italiano de La Plata

    La Plata, Buenos Aires, 1900

  • Centro Oncologico Riojano Integral

    La Rioja, F5300COE

  • Hospital Provincial del Centenario

    Rosario, Santa Fe Province, S2002KDS

  • Exelsus Oncologia Clinica

    San Miguel de Tucumán, Tucumán Province, T4000

  • Fundacion Ars Medica

    San Salvador de Jujuy, Jujuy Province, 4600

  • Clinica Viedma

    Viedma, Río Negro Province, 8500

Other trials in Argentina

Poland12 sites

  • Beskidzkie Centrum Onkologii Szpital Miejski imienia Jana Pawla Drugiego

    Bielsko-Biala, 43-300

  • Narodowy Instytut Onkologii im M Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwicach

    Gliwice, 44-102

  • Przychodnia Lekarska Komed Roman Karaszewski

    Konin, 62-500

  • Samodzielny Publiczny Szpital Kliniczny Nr 1

    Lublin, 20-080

  • Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji

    Olsztyn, 10-228

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

    Siedlce, 08-110

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60-185

  • Uniwersytecki Szpital Kliniczny nr 1 im prof Tadeusza Sokolowskiego Pum w Szczecinie

    Szczecin, 71-252

  • Lux med onkologia sp zoo szpital szamocka

    Warsaw, 01-748

  • Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

    Warsaw, 02-034

  • Mtz Clinical Research powered by Pratia

    Warsaw, 02-172

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, 50-556

Other trials in Poland

Belgium10 sites

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Brussels, 1200

  • Institut Jules Bordet

    Brussels, B-1070

  • Grand Hopital de Charleroi

    Charleroi, 5530

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Universitair Ziekenhuis Brussel

    Jette, 1090

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000

  • Hopital De Libramont

    Libramont, 6800

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 4000

  • Algemeen Ziekenhuis Turnhout Campus Sint-Jozef

    Turnhout, 2300

Other trials in Belgium

United Kingdom10 sites

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • University Hospital Coventry

    Coventry, CV2 2DX

  • Ninewells Hospital and Medical School

    Dundee, DD1 9SY

  • Royal Free Hospital

    London, NW3 2QG

  • Guys Hospital

    London, SE1 9RT

  • Christie Hospital

    Manchester, M20 4BX

  • Mount Vernon Cancer Centre

    Northwood, HA6 2RN

  • Churchill Hospital

    Oxford, OX3 7LE

  • Southampton General Hospital

    Southampton, SP16 6YD

  • Torbay Hospital

    Torquay, TQ2 7AA

Other trials in United Kingdom

Hungary8 sites

  • Semmelweis Egyetem

    Budapest, 1082

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

    Budapest, 1097

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

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

    Nyíregyháza, 4400

  • Tolna Varmegyei Balassa Janos Korhaz

    Szekszárd, 7100

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

    Szolnok, 5000

  • Komarom-Esztergom Varmegyei Szent Borbala Korhaz

    Tatabánya, 2800

Other trials in Hungary

Portugal8 sites

  • Unidade Local de Saude de Braga, EPE

    Braga, 4710-243

  • Unidade Local de Saude do Alto Ave, EPE

    Guimarães, 4835-044

  • Hospital da Luz, SA

    Lisbon, 1500-650

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

    Lisbon, 1649-035

  • Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

    Matosinhos Municipality, 4464-513

  • Hospital Cuf porto

    Porto, 4100-180

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072

  • Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao

    Porto, 4200-319

Other trials in Portugal

Chile7 sites

  • IC La Serena Research

    La Serena, 1720430

  • Centro De Estudios Clínicos Suecia SpA

    Santiago, Santiago Metropolitan, 7510062

  • Centro de Estudios Clinicos SAGA Spa

    Santiago, 7500653

  • Oncovida

    Santiago, 7510032

  • Icegclinic

    Santiago, 8241479

  • Centro de Estudios Clinicos e Investigaciones Medicas CeCim

    Santiago, 8330336

  • Oncocentro Apys

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Romania7 sites

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor

    Cluj-Napoca, 400000

  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

    Cluj-Napoca, 400015

  • Centrul de Oncologie Sf Nectarie SRL

    Craiova, 200542

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

  • Spitalul Municipal Ploiesti

    Ploieşti, 100337

  • SC Oncomed SRL

    Timișoara, 300239

Other trials in Romania

Austria6 sites

  • Medizinische Universitaet Graz

    Graz, 8036

  • Medizinische Universitaet Innsbruck

    Innsbruck, 6020

  • Landeskrankenhaus Feldkirch

    Rankweil, 6830

  • Landeskrankenhaus Salzburg

    Salzburg, 5020

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, 1090

  • Krankenhaus Wiener Neustadt

    Wiener Neustadt, 2700

Other trials in Austria

Bulgaria6 sites

  • Complex Oncology Center - Burgas

    Burgas, 8000

  • Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD

    Haskovo, 6300

  • Multiprofile Hospital for Active Treatment - Uni Hospital OOD

    Panagyurishte, 4500

  • Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

    Plovdiv, 4000

  • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

    Sofia, 1606

  • Multiprofile Hospital for Active Treatment Serdika EOOD

    Sofia, 1632

Other trials in Bulgaria

Canada6 sites

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • Centre Hospitalier de L Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • CHU de Quebec Hopital de l Enfant Jesus

    Québec, Quebec, G1J 1Z4

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M4G 2C1

  • Sunnybrook Research Institute Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Switzerland6 sites

  • Universitaetsspital Basel

    Basel, 4031

  • Inselspital Bern

    Bern, 3010

  • Kantonsspital Graubuenden

    Chur, 7000

  • Hopitaux Universitaires de Geneve

    Geneva, 1205

  • Onkozentrum Zuerich

    Zurich, 8038

  • Universitaetsspital Zuerich

    Zurich, 8091

Other trials in Switzerland

Taiwan6 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 70403

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Tri-Service General Hospital

    Taipei, 11490

  • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

    Taoyuan, 33305

Other trials in Taiwan

Australia5 sites

  • Grampians Health

    Ballarat, Victoria, 3350

  • Austin Health, Austin Hospital

    Heidelberg, Victoria, 3084

  • GenesisCare -North Shore Oncology

    St Leonards, New South Wales, 2065

  • Calvary Mater Newcastle Hospital

    Waratah, New South Wales, 2298

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Colombia5 sites

  • Fundacion Cardiovascular de Colombia

    Bucaramanga, Santander Department, 681017

  • Fundacion Oftalmologica de Santander - Foscal

    Floridablanca, Santander Department, 681004

  • Hospital Pablo Tobon Uribe

    Medellín, Antioquia, 050034

  • Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA

    Rionegro, Antioquia, 054040

  • Sociedad de Oncologia y Hematologia del Cesar

    Valledupar, Cesar Department, 200001

Other trials in Colombia

Czechia5 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

  • Fakultni Thomayerova nemocnice

    Prague, 140 59

Other trials in Czechia

Israel5 sites

  • Rambam Health Care Campus

    Haifa, 3109601

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah Ein-Kerem Medical Center

    Jerusalem, 9112001

  • Sheba Medical Center

    Ramat Gan, 5262000

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Thailand5 sites

  • Chulabhorn Hospital

    Bangkok, 10210

  • Siriraj Hospital

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

  • Chiangrai Prachanukroh Hospital

    Chiang Rai, 57000

  • Prince of Songkla Hospital

    Songkhla, 90110

Other trials in Thailand

Singapore2 sites

  • National University Hospital

    Singapore, 119074

  • National Cancer Centre Singapore

    Singapore, 168583

Other trials in Singapore

Hong Kong1 site

  • Prince of Wales Hospital / CUHK

    Shatin, New Territories

Other trials in Hong Kong

About this study

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

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.

Being tested
Bemarituzumab, Nivolumab, Chemotherapy, Placebo
Keywords
Bemarituzumab, AMG 552, 5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6), Nivolumab, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, FGFR2b Overexpression, Capecitabine and Oxaliplatin (CAPOX)
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BemarituzumabDrug

    Also called AMG 552

    Bemarituzumab will be administered as intravenous (IV) infusion.

  • NivolumabDrug

    Nivolumab will be administered as IV infusion.

  • ChemotherapyDrug

    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.

  • PlaceboOther

    Placebo will be administered as IV infusion.

Study groups in NCT05111626
Study groupRoleWhat they receive
Part 1 Safety Lead-in: Bemarituzumab with mFOLFOX6 and NivolumabExperimentalParticipants will be administered bemarituzumab at different doses with mFOLFOX6 and nivolumab to determine the recommended phase 3 dose (RP3D) based on occurrence of dose-limiting toxicities (DLTs), and on an evaluation of the overall safety, tolerability, and pharmacokinetics (PK).
Receives: Drug: Bemarituzumab; Drug: Nivolumab; Drug: Chemotherapy
Part 2: Bemarituzumab with chemotherapy (mFOLFOX6 or CAPOX) and NivolumabExperimentalParticipants will be administered bemarituzumab at the RP3D determined from Part 1 in combination with mFOLFOX6 and nivolumab on a 14-day cycle. Or participants will be administered bemarituzumab in combination with CAPOX and nivolumab on a 21-day cycle.
Receives: Drug: Bemarituzumab; Drug: Nivolumab; Drug: Chemotherapy
Part 2: Placebo with chemotherapy (mFOLFOX6 or CAPOX) and NivolumabPlacebo comparatorParticipants will be administered placebo comparator in combination with mFOLFOX6 and nivolumab on a 14-day cycle. Or participants will be administered placebo comparator in combination with CAPOX and nivolumab on a 21-day cycle.
Receives: Drug: Nivolumab; Drug: Chemotherapy; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants Who Experienced DLTs

    Measured: 28 days

  2. Part 1: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)

    Measured: Up to 4.5 years

  3. Part 1: Number of Participants Who Experienced One or More Related TEAEs

    Measured: Up to 4.5 years

  4. Part 1: Number of Participants With Clinically Significant Changes in Vital Signs

    Measured: Up to 4.5 years

  5. Part 1: Number of Participants With Clinically Significant Changes in Visual Acuity

    Measured: Up to 4.5 years

  6. Part 1: Number of Participants With Clinically Significant Changes in Physical Examinations

    Measured: Up to 4.5 years

  7. Part 1: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests

    Measured: Up to 4.5 years

  8. Part 2: Overall Survival in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants

    Measured: Up to 4.5 years

Secondary outcomes (32)

  1. Part 1: Objective Response (OR)

    Measured: Up to 4.5 years

  2. Part 1: Duration of Response (DoR)

    Measured: Up to 4.5 years

  3. Part 1: Disease Control Rate (DCR)

    Measured: Up to 4.5 years

  4. Part 1: Progression Free Survival (PFS)

    Measured: Up to 4.5 years

  5. Part 1: Overall Survival

    Measured: Up to 4.5 years

  6. Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab

    Measured: Day 1 to up to 4.5 years

  7. Part 1: Area Under the Concentration Time Curve (AUC) of Bemarituzumab

    Measured: Day 1 to up to 4.5 years

  8. Part 1: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab

    Measured: Day 1 to up to 4.5 years

  9. Part 1: Number of Participants With Anti-Bemarituzumab Antibody Formation

    Measured: Day 1 to up to 4.5 years

  10. Part 2: PFS in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants

    Measured: Up to 4.5 years

  11. Part 2: Overall Survival in All Randomized Participants

    Measured: Up to 4.5 years

  12. Part 2: PFS in All Randomized Participants

    Measured: Up to 4.5 years

  13. Part 2: Number of Participants Who Experienced One or More TEAEs

    Measured: Up to 4.5 years

  14. Part 2: Number of Participants With Clinically Significant Changes in Vital Signs

    Measured: Up to 4.5 years

  15. Part 2: Number of Participants With Clinically Significant Changes in Visual Acuity

    Measured: Up to 4.5 years

  16. Part 2: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests

    Measured: Up to 4.5 years

  17. Part 2: OR

    Measured: Up to 4.5 years

  18. Part 2: DoR

    Measured: Up to 4.5 years

  19. Part 2: DCR

    Measured: Up to 4.5 years

  20. 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

    Measured: Up to 4.5 years

  21. Part 2: Change From Baseline in EORTC QLQ-C30 Individual Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants

    Measured: Baseline to up to 4.5 years

  22. 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

    Measured: Up to 4.5 years

  23. Part 2: Change From Baseline in Stomach Cancer Related Symptoms Measured by EORTC QLQ-STO22 in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants

    Measured: Baseline to up to 4.5 years

  24. 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

    Measured: Up to 4.5 years

  25. Part 2: Change From Baseline of VAS Scores as Measured by EQ-5D-5L in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants

    Measured: Baseline to up to 4.5 years

  26. Part 2: Time to Deterioration in Stomach Cancer Related Symptoms Measured by EORTC QLQ-STO22 in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants

    Measured: Day 1 to up to 4.5 years

  27. Part 2: Time to Deterioration in Health-Related Quality of Life (HRQoL) Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants

    Measured: Day 1 to up to 4.5 years

  28. Part 2: Time to Deterioration in Physical Function Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants

    Measured: Day 1 to up to 4.5 years

  29. Part 2: AUC of Bemarituzumab

    Measured: Day 1 to up to 4.5 years

  30. Part 2: Cmax of Bemarituzumab

    Measured: Day 1 to up to 4.5 years

  31. Part 2: Ctrough of Bemarituzumab

    Measured: Day 1 to up to 4.5 years

  32. Part 2: Number of Participants With Anti-Bemarituzumab Antibody Formation

    Measured: Day 1 to up to 4.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2021
  2. Study start14 Mar 2022
  3. Primary completion14 Oct 2025
  4. Study completion29 Oct 2025

Why it stopped: Study was terminated by sponsor

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
This is a Phase 1b/3 study: * Phase 1b (Part 1) is a single-arm open-label study, which will enroll about 20 participants * Phase 3 (Part 2) is a randomized double-blind 2-arm study, which will enroll 508 participants
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
515 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05111626
Sponsor's protocol ID
20210098
Other IDs
2023-505458-16, 2023
Acronym
FORTITUDE-102
Status last verified
Sep 2026
First submitted
29 Oct 2021
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Publications

  • Maron SB, Xu RH, Wainberg ZA, Rha SY, Zhang Y, Pietrantonio F, Oliveira SCS, Li Y, Chen MH, Korphaisarn K, Elimova E, Calderon CA, Herpe FV, Yong WP, Dos Santos TM, Tan M, Isse K, Yanes RE, Shitara K. Global prevalence of FGFR2b protein overexpression in advanced gastric cancer and gastroesophageal junction cancers: pooled analysis of two bemarituzumab phase III studies. ESMO Open. 2026 Jun;11(6):107698. doi: 10.1016/j.esmoop.2026.107698. Epub 2026 May 26.

    PubMed 42190313

  • Yu J, Mehta R. Biomarker-Driven Approach to the Treatment of Metastatic Gastric or Gastroesophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257036. doi: 10.6004/jnccn.2025.7036.

    PubMed 40341124

  • Wainberg ZA, Kang YK, Lee KW, Qin S, Yamaguchi K, Kim IH, Saeed A, Oh SC, Li J, Turk HM, Teixeira A, Hitre E, Udrea AA, Cardellino GG, Sanchez RG, Zahlten-Kumeli A, Taylor K, Enzinger PC. Bemarituzumab as first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma: final analysis of the randomized phase 2 FIGHT trial. Gastric Cancer. 2024 May;27(3):558-570. doi: 10.1007/s10120-024-01466-w. Epub 2024 Feb 3.

    PubMed 38308771

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bemarituzumab, Nivolumab and Chemotherapy in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Amgen at 348 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 348 sites in China, United States, Japan, France, Spain and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study was terminated by sponsor). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants Who Experienced DLTs (time frame: 28 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05111626, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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