A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT)

FIGHT: A Phase 2 Randomized, Double-Blind, Controlled Study Evaluating Bemarituzumab (FPA144) and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Preceded by Dose-Finding in Phase 1

The main objective of the Phase 2 part of the study is to evaluate the efficacy of bemarituzumab (FPA144), a targeted antibody, in combination with modified FOLFOX6 compared to placebo in combination with modified FOLFOX6 in participants with advanced gastrointestinal cancer.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Biological: Bemarituzumab; Drug: Modified FOLFOX6; Drug: Placebo

Detailed Description

Study FPA144-004 is a phase 1/2, multicenter, global, double-blind, randomized, controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of bemarituzumab in combination with mFOLFOX6, compared with placebo in combination with mFOLFOX6, in adults with unresectable, locally advanced, or metastatic gastric cancer including cancer of the gastroesophageal junction (GEJ).

This study includes a Phase 1 safety run-in portion and a Phase 2 portion. The Phase 1 safety run-in is an open-label dose-escalation of bemarituzumab + mFOLFOX6 in patients with GI tumors (not FGFR2 selected) that is reported separately (NCT03343301).

The Phase 2 portion of the study (to follow the Phase 1 safety run-in) is described in this record.

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Camperdown, Australia
    • Chris O'Brien Lifehouse
  • Douglas, Australia
    • The Townsville Hospital
  • Wahroonga, Australia
    • Sydney Adventist Hospital
• Belgium
  • Brugge, Belgium
    • AZ Sint Jan
  • Libramont, Belgium, 6800
    • CH de l'Ardenne
  • Liege, Belgium, 04000
    • CHC Clinique Saint-Joseph
  • Yvoir, Belgium, 05530
    • CHU UCL Namur, site Godinne
• China
  • Beijing, China
    • Chinese PLA General Hospital
  • Beijing, China, 100412
    • Beijing Cancer Hospital
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Changchun, China, 130033
    • Sino Japanese Friendship Hospital of Jilin University
  • Changsha, China, 410006
    • Hunan Cancer Hospital
  • Changsha, China
    • Xiangya Hospital of Central South University
  • Chongqing, China, 400000
    • Chongqing Daping Hospital
  • Fuzhou, China, 350014
    • Fujian Cancer Hospital
  • Hangzhou, China
    • Zhejiang Cancer hospital
  • Hangzhou, China, 310003
    • The First Affiliated Hospital, Zhejiang University
  • Hangzhou, China
    • Sir Run Run Shaw Hospital
  • Harbin, China
    • Harbin Medical University Cancer Hopsital
  • Nantong, China
    • Nanton Tumor Hospital
  • Shanghai, China, 200123
    • Shanghai East Hospital
  • Shanghai, China, 210032
    • Fudan University Shanghai Cancer Center
  • Shanghai, China
    • Ruijin Hospital Affiliated to Shanghai Jiatong University School of Medicine
  • Shantou, China, 515041
    • Cancer Hospital of Shantou University Medical College
  • Shenyang, China, 110042
    • Liaoning Cancer Hospital
  • Shijiazhuang, China
    • Fourth Hospital of Hebei Medical University
  • Suzhou, China, 215004
    • The Second Affiliated Hospital of Soochow University
  • Tianjin, China, 300060
    • Tianjin Medical University Cancer Institute and Hospital
  • Zhengzhou, China, 450008
    • Henan Cancer Hospital
  • Anhui
    • Hefei, Anhui, China, 230031
      • Anhui Provincial Cancer Hospital
  • Hubei
    • Shiyan, Hubei, China, 442000
      • Shiyan Taihe Hospital
    • Wuhan, Hubei, China, 430000
      • Wuhan Union Hospital of China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • The 81st Hospital of Chinese PLA
• France
  • Besançon, France, 25000
    • CHRU Jean Minjoz
  • Brest, France
    • Chu Morvan - Institut de Cancerologie
  • Montbéliard, France, 25200
    • Hopital Nord France Comte - Site Le Mittan
  • Nancy, France
    • Polyclinique de Gentilly
  • Saint-Étienne, France, 42055
    • CHU de Saint Etienne
  • Strasbourg, France
    • Centre Paul Strauss
  • Strasbourg, France, 67000
    • Centre de Radiothérapie - Clinique Sainte Anne
• Germany
  • Berlin, Germany, 12559
    • Klinik fur Innere Medizin, Shwerpunkt Gastroenterologie, Hamatologie, Onkologie, Nephrologie
  • Braunschweig, Germany, 38114
    • Städtisches Klinikum Braunschweig
  • Frankfurt am Main, Germany, 60488
    • Krankenhaus Nordwest gGmbH, Institut fur Klinisch-Onkologische Forschung
  • Ludwigsburg, Germany, 71640
    • Klinikum Ludwigsburg
  • Mannheim, Germany
    • Universitatsmedizin Manheim, II. Medizinische Klinik
  • Mutlangen, Germany
    • Klinikum Ostalb, Stauferklinikum Schwabisch Gmund, Zentrum fur Innere Medizin
  • Oberpfalz, Germany, 92637
    • Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik I
• Hungary
  • Budapest, Hungary, 1122
    • National Institute of Oncology
  • Budapest, Hungary
    • Del-Pesti Centrumkorhaz - Orszangos Hematologiai es Infektologiai Intezet, Onkologiai Osztaly
  • Miskolc, Hungary
    • Sugarterapias es Klinikai Onkologaiai Intezet B-A-Z Megyei Korhaz
  • Nyíregyháza, Hungary, 4400
    • Josa Andras Teaching Hospital
  • Pecs, Hungary, 7624
    • University of Pecs, Clinic of Oncotherapy
  • Szolnok, Hungary, 5000
    • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet
• Italy
  • Ancona, Italy, 60020
    • AOU Ospedall Riuniti Umberto
  • Avellino, Italy
    • AO "S.G. Moscati"
  • Aviano, Italy, 33081
    • Centro di Riferimento Oncologico
  • Brescia, Italy
    • Azienda Ospedaliera Spedali Civili Di Brescia-Universita Degli Studi Di Brescia
  • Candiolo, Italy, 10060
    • Istituto di Ricovero e Cura a Carattere Scientifico - IRCCS di Candiolo
  • Cremona, Italy, 26100
    • Azienda Socio-Sanitaria Territoriale di Cremona
  • Firenze, Italy
    • Azienda Ospedaliero Universitaria Caregg - I S.O.D. Oncologia Medica
  • Genova, Italy, 16132
    • Ospedale Policlinico S. Martino
  • Legnago, Italy, 37045
    • Ospedale Generale Mater Salutis" - Azienda ULSS n. 21 di Legnago
  • Meldola, Italy, 47014
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Milan, Italy, 20141
    • Istituto Europeo Di Oncologia
  • Napoli, Italy, 80131
    • Servizio Oncologia Medica ed Ematologia, AOU dell'Universita
  • Pavia, Italy
    • Fondazione IRCCS Policlinico San Matteo
  • Pisa, Italy
    • Azienda Ospedaliera Universitaria Pisana
  • Roma, Italy
    • Policlinico Universitario Campus Bio-Medico di Roma
  • San Giovanni Rotondo, Italy
    • Fondazione IRCSS Casa Sollievo Della Sofferenza
  • Sondrio, Italy
    • ASST della Valtellina e dell'Alto Lario - PO di Sondrio
  • Torino, Italy
    • A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
  • Udine, Italy, 33100
    • Azienda Sanitaria Universitaria Integrata de Udine
• Japan
  • Bunkyō-Ku, Japan
    • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
  • Hiroshima, Japan, 730-8518
    • Hiroshima Citizens Hospital
  • Kawasaki, Japan, 216-8511
    • St. Marianna University School of Medicine Hospital
  • Kitakyushu, Japan
    • Japan Community Health care Organization Kyushu Hospital
  • Koto-Ku, Japan
    • The Cancer Institute Hospital of JFCR
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Nishinomiya, Japan, 663-8501
    • Hyogo College of Medicine College Hospital
  • Osaka, Japan, 558-8558
    • Osaka General Medical Center
  • Osaka, Japan, 569-8686
    • Osaka Medical College Hospital
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Kagawa
    • Kita-gun, Kagawa, Japan, 761-0793
      • Kagawa University Hospital
• Korea, Republic of
  • Busan, Korea, Republic of, 49201
    • Dong-A University Hospital
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital (CNUH)
  • Seoul, Korea, Republic of, 3080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 03722
    • Yonsei University Health System
  • Seoul, Korea, Republic of, 04514
    • Kangbuk Samsung Hospital
  • Gangnam
    • Seoul, Gangnam, Korea, Republic of, 06273
      • Gangnam Severance Hospital, Yonsei University Health System
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
    • Suwon, Gyeonggi, Korea, Republic of, 16499
      • Ajou University Hospital
  • Gyeonggi-do
    • Anyang, Gyeonggi-do, Korea, Republic of, 14068
      • Hallym University Sacred Heart Hospital
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Chonbuk National University Hospital
  • Namdong-gu
    • Incheon, Namdong-gu, Korea, Republic of, 21565
      • Gachon University Gil Medical Center
  • North Gyeongsang
    • Daegu, North Gyeongsang, Korea, Republic of
      • Kyungpook National University Chilgok Hospital
• Poland
  • Bielsko-Biala, Poland, 43-300
    • Beskidzkie Centrum Onkologii - Szpital Miejski im. Jana Pawla II w Bielsku-Bialej
  • Brzozów, Poland, 36-200
    • Szpital Specjalistyczny w Brzozowie, Podkarpacki Osrodek Onkologiczny
  • Lublin, Poland
    • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
  • Olsztyn, Poland, 10-228
    • SP ZOZ Ministerstwa Spraw Wewnetrznych z Warminsko - Mazurskim Centrum Onkologii
  • Otwock, Poland, 05-400
    • Europejskie Centrum Zdrowia Otwock Szpital im. F. Chopina
  • Rzeszów, Poland, 35-021
    • Lekarz Beata Madej Mruk I Partner. Spolka Partnerska Oddzial nr 1 w Rzesowie
  • Warszawa, Poland, 04-141
    • Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej
  • Warszawa, Poland
    • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Onkologi I Radioterapii
• Portugal
  • Aveiro, Portugal, 3814-501
    • Centro Hospitalar do Baixo Vouga, EPE
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Guimarães, Portugal
    • Hospital Senhora Da Oliveira EPE
  • Porto, Portugal, 4099-011
    • Centro Hospitalar Universitario do Porto E.P.E
  • Porto, Portugal
    • Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E
  • Santa Maria Da Feira, Portugal
    • Centro Hospitalar de Entre o Douro e Vouga EPE
  • Senhora Da Hora, Portugal
    • Unidade Local de Saude de Matosinhos EPE
• Romania
  • Bucharest, Romania, 022328
    • Institutul Clinic Fundeni - Clinica Pediatrie
  • Cluj Napoca, Romania, 400641
    • S.C. Medisprof S.R.L
  • Cluj-Napoca, Romania, 400015
    • Institutul Oncologic, Prof. Dr. I. Chiricuta Cluj-Napoca
  • Constanţa, Romania, 900591
    • Spitalul Clinic Judetean de Urgenta ,,Sf. Apostol Andrei" Constanta, Clinica Oncologie Medicala
  • Craiova, Romania, 200347
    • S.C. Centrul de Oncologie Sf. Nectarie S.R.L., Oncologie Medicala
  • Craiova, Romania, 200385
    • SC Oncolab SRL, Oncologie
  • Timisoara, Romania, 300166
    • S.C. Oncocenter Oncologie Clinica S.R.L
• Spain
  • A Coruña, Spain
    • Complejo Hospitalario Universitario A Coruña
  • Alcorcon, Spain
    • Hospital Universitario Fundacion Alcorcon
  • Barcelona, Spain, 08003
    • Hospital Del Mar
  • Barcelona, Spain
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain
    • Hospital General de Catalunya
  • Barcelona, Spain, 08908
    • Hospital Duran I Reynals - Instituto Catalan de Oncologia
  • Girona, Spain, 17007
    • Institut Catala d'Oncologia - Hospital Doctor Josep Trueta
  • Lleida, Spain
    • Hospital Universitari Arnau de Vilanova
  • Madrid, Spain
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28050
    • Hospital Universitario Hm Sanchinarro
  • Majadahonda, Spain
    • Hospital Universitario Puerta de Hierro Majadahonda
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra
  • Pamplona, Spain, 31008
    • Complejo Hospital De Navarra
  • Sabadell, Spain
    • Corporacio Sanitaria Parc Tauli
  • Servilla, Spain, 41009
    • Hosptial Universitario Virgen Macarena
  • Terrassa, Spain, 08221
    • Hospital Universitario Mutua de Terrassa
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
• Thailand
  • Bankok, Thailand
    • Faculty of Medicine, Chulalongkorn University
  • Chiang Rai, Thailand
    • Chiangrai Prachanukroh Hospital
  • Hat Yai, Thailand, 90110
    • Faculty of Medicine, Prince of Sonkla University
  • Khon Kaen, Thailand
    • Khon Kaen Hospital
  • Lampang, Thailand
    • Lampang Cancer Hospital
• Turkey
  • Adana, Turkey
    • Cukurova University Faculty of Medicine Paediatric Nephrology
  • Ankara, Turkey, 06100
    • Hacettepe Universitesi Tip Fakultesi
  • Ankara, Turkey, 06200
    • Ankara Oncology Education and Research Hospital
  • Atakum, Turkey, 55200
    • Ondokuz Mayis University Medicine Faculty
  • Aydin, Turkey, 09100
    • Adnan Menderes Universitesi Uygulama ve Arastirma Hastanesi
  • Bursa, Turkey, 16059
    • Uludag Universitesi Tip Fakultesi
  • Gaziantep, Turkey
    • Gaziantep Universitesi Tip Fakultesi, Sahinbey Onkoloji Hastanesi
  • Istanbul, Turkey
    • Istanbul University Cerrahpasa Medical Faculty
  • Istanbul, Turkey, 34093
    • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
  • Istanbul, Turkey
    • Istanbul Madeniyet Universitesi Tip Fakultesi
  • Izmir, Turkey, 35575
    • Medical Park Izmir Hastanesi
  • Izmir, Turkey
    • Ege University Hopsital
  • Kocaeli, Turkey, 41380
    • Kocaeli Universitesi Tip Fakultesi
  • Malatya, Turkey, 44300
    • Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi
  • Van, Turkey, 65080
    • Yuzuncuyil Universitesi Tip Fakultesi
• United Kingdom
  • Dundee, United Kingdom, DD198Y
    • Ninewells Hospital and Medical School
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Cancer Center
    • Tucson, Arizona, United States, 85745
      • The Oncology Institute of Tuscon
  • California
    • Greenbrae, California, United States, 94904
      • Marin Cancer Care, Inc-California Cancer Care A Medical Group, Inc
    • Sacramento, California, United States, 95816
      • Sutter Medical Group
    • Santa Monica, California, United States, 90404
      • UCLA Medical Centre - Santa Monica Hematology and Oncology
    • Whittier, California, United States, 90603
      • Innovative Clinical Research Institute (ICRI)
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale Cancer Center
    • Plainville, Connecticut, United States, 06062
      • Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Warrenville, Illinois, United States, 60555
      • Northwestern Medicine Cancer Center Warrenville
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Oschsner Clinic Foundation
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
    • Detroit, Michigan, United States, 48202
      • Josephine Ford Cancer Center-Henry Ford Cancer Center
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Summit Medical Group. Morristown Oncology
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center)
    • Stony Brook, New York, United States, 11794
      • Stony Brook Cancer Center
    • White Plains, New York, United States, 10601
      • Westchester Institute For Treatment Of Cancer & Blood Disorders
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC- Chapel Hill
    • Pinehurst, North Carolina, United States, 28374
      • FirstHealth Outpatient Cancer Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Physician Group - St. Luke's Cancer Care Associates
  • South Carolina
    • Charleston, South Carolina, United States, 29435
      • Medical University of South Carolina
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Tennessee Cancer Specialists
  • Texas
    • Arlington, Texas, United States, 76012
      • Arlington Cancer Center
  • Utah
    • S. Salt Lake, Utah, United States, 84106
      • Utah Cancer Specialists (Intermountain Hematology - Oncology Associates) UCS Cancer Center
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Seattle Main Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Histologically documented gastric or gastroesophageal junctional adenocarcinoma (not amenable to curative therapy)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Adequate hematological, liver and kidney function. Measurable or non-measurable, but evaluable disease using RECIST v1.1
• Fibroblast growth factor receptor 2b (FGFR2b) overexpression as determined by a centrally performed immunohistochemistry tissue test and/or FGFR2 gene amplification as determined by a centrally performed circulating tumor deoxyribonucleic acid (ctDNA) blood based assay
• Candidate for mFOLFOX6 chemotherapy

Key Exclusion Criteria:

• Untreated or symptomatic central nervous system (CNS) metastases
• Clinically significant cardiac disease,
• Peripheral sensory neuropathy >/= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
• Active infection requiring systemic treatment
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection
• Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
• Known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
• Known positivity for human epidermal growth factor receptor 2 (HER2)
• Women who are pregnant or breastfeeding

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bemarituzumab + mFOLFOX6; Participants received 15 mg/kg bemarituzumab administered every 2 weeks (Q2W) with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.	Biological: Bemarituzumab; Administered by intravenous infusion over approximately 30 minutes; Other Names: AMG 552; FPA144; Drug: Modified FOLFOX6; mFOLFOX6 regimen consists of the following: Oxaliplatin 85 mg/m² IV infusion over 120 minutes; Leucovorin 400 mg/m² IV infusion over 120 minutes, or 200 mg/m² levo-leucovorin if leucovorin is unavailable; 5-fluorouracil (5-FU) 400 mg/m² bolus over approximately 5 minutes then 5-FU 2400 mg/m² as a continuous IV infusion over approximately 48 hours; Other Names: mFOLFOX6
Placebo Comparator: Placebo + mFOLFOX6; Participants received placebo for bemarituzumab administered every 2 weeks with a single additional placebo dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.	Drug: Modified FOLFOX6; mFOLFOX6 regimen consists of the following: Oxaliplatin 85 mg/m² IV infusion over 120 minutes; Leucovorin 400 mg/m² IV infusion over 120 minutes, or 200 mg/m² levo-leucovorin if leucovorin is unavailable; 5-fluorouracil (5-FU) 400 mg/m² bolus over approximately 5 minutes then 5-FU 2400 mg/m² as a continuous IV infusion over approximately 48 hours; Other Names: mFOLFOX6; Drug: Placebo; Administered by intravenous infusion over approximately 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS was defined as time from randomization until the date of radiographic disease progression based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death from any cause, whichever came first. PFS was analyzed using Kaplan-Meier methods. Participants with no progression or death, or who started new anticancer therapy before documented progression or death without documented progression, or who had ≥ 2 consecutive missing tumor assessments before documented progression or death without documented progression were censored on the date of last adequate tumor assessment. Participants with no baseline tumor assessment, were censored at the date of randomization. The primary efficacy analysis was pre-specified to be conducted after at least 84 PFS events were observed.	From randomization until the primary analysis data cut-off date of 23 September 2020; median time on follow-up was 10.9 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	Tumor response assessment was performed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines. ORR is defined as the percentage of participants who achieved a best overall response (BOR) of either complete response (CR) or partial response (PR) based on investigator assessment of tumor lesions per RECIST v1.1. CR was defined as the disappearance of all lesions except lymph node short axis < 10 mm; PR was defined as a ≥ 30% reduction in sum of diameters in target lesions.	Tumor assessments were performed every 8 weeks until 12 months and then every 12 weeks thereafter until disease progression or additional anticancer therapy was initiated; the median duration of follow-up time was 10.9 months.
Overall Survival (OS)	OS is defined as time from randomization until death from any cause. Participants who were lost to follow-up or did not have a date of death were censored at the last date that they were known to be alive. Participants with confirmed death or alive status after the data cutoff date were censored at the data cutoff date. Median OS was estimated using a Kaplan-Meier analysis.	From randomization until the primary analysis data cut-off date of 23 September 2020; median time on follow-up was 10.9 months.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	TEAEs are defined as adverse events (AEs) that started or worsened from the start of study drug to 28 days after permanent discontinuation of study drug. A serious AE is defined as any untoward medical occurrence that: Resulted in death;; Was life-threatening;; Required inpatient hospitalization or prolongation of existing hospitalization;; Resulted in persistent or significant disability or incapacity;; Was a congenital anomaly or birth defect. The investigator assessed the causality/relationship between study treatment and each AE, and assessed the severity of each AE according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0 on a scale from mild (Grade 1), moderate (Grade 2), severe (Grade 3), life-threatening (Grade 4), or death due to the AE (Grade 5). Cornea and retina AEs were defined by Standardized Medical Dictionary for Regulatory Activities Queries (SMQs) of corneal disorders and retinal disorders (broad).	From first dose of study drug to 28 days after last dose of study drug. Actual median (min, max) duration of treatment emergent period was 29 (4.1, 157) weeks in the bemarituzumab + mFOLFOX6 group and 28 (4.3, 133) weeks in the placebo + mFOLFOX6 group.

Collaborators and Investigators

• Sponsor: Five Prime Therapeutics, Inc.
• Collaborators: Zai Lab (Shanghai) Co., Ltd.
• Investigators: Study Director: MD, Amgen

Publications and helpful links

General Publications

• Wainberg ZA, Enzinger PC, Kang YK, Qin S, Yamaguchi K, Kim IH, Saeed A, Oh SC, Li J, Turk HM, Teixeira A, Borg C, Hitre E, Udrea AA, Cardellino GG, Sanchez RG, Collins H, Mitra S, Yang Y, Catenacci DVT, Lee KW. Bemarituzumab in patients with FGFR2b-selected gastric or gastro-oesophageal junction adenocarcinoma (FIGHT): a randomised, double-blind, placebo-controlled, phase 2 study. Lancet Oncol. 2022 Nov;23(11):1430-1440. doi: 10.1016/S1470-2045(22)00603-9. Epub 2022 Oct 14.
• Xiang H, Liu L, Gao Y, Ahene A, Macal M, Hsu AW, Dreiling L, Collins H. Population pharmacokinetic analysis of phase 1 bemarituzumab data to support phase 2 gastroesophageal adenocarcinoma FIGHT trial. Cancer Chemother Pharmacol. 2020 Nov;86(5):595-606. doi: 10.1007/s00280-020-04139-4. Epub 2020 Sep 23.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2018
• Primary Completion (Actual): September 23, 2020
• Study Completion (Actual): May 13, 2022

Study Registration Dates

• First Submitted: September 14, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Bemarituzumab
• Other Study ID Numbers: FPA144-004 Phase 2; 2017-003507-22 (EudraCT Number); 20210113 (Other Identifier: Amgen)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No