Study Details

A Phase 3 efficacy, safety and tolerability study of zolbetuximab (experimental drug) plus mFOLFOX6 chemotherapy compared to placebo plus mFOLFOX6 as treatment for gastric and gastroesophageal junction (GEJ) cancer

Recruitment complete
The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT03504397

Astellas Study ID

The unique identification code given by the study sponsor.

8951-CL-0301

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2017-002567-17

Condition

Stomach or Esophageal Cancer

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

18 Years - N/A N/A

Sex

Female & Male

Product

zolbetuximab

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jun 2018 - Jan 2025

Masking

Double (Participant, Investigator)

Enrollment number

566

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Study summary

Get More Information

Would you like more information about clinical trial sites that are recruiting participants for A Phase 3 efficacy, safety and tolerability study of zolbetuximab (experimental drug) plus mFOLFOX6 chemotherapy compared to placebo plus mFOLFOX6 as treatment for gastric and gastroesophageal junction (GEJ) cancer? Contact us by filling our your information to the right and we’ll respond to you.

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Locations

Site JP81007

Sapporo, Japan

Site JP81012

Sunto-gun, Japan

Oregon Health & Science University

Portland, United States, 97239

Site DE49007

Munchen, Germany, 81925

Site KR82009

Suwon-si, Republic of Korea, 16247

Site BR55003

Santo Andre, Brazil, 09060-650

Site DE49010

Dresden, Germany, 01307

Site GB44104

Dundee, United Kingdom, DD2 4BF

Site DE49017

Berlin, Germany, 12200

Site DE49011

Berlin, Germany, 13353

Site FR33101

St Herblain, France, 44805

Site BR55017

Belo Horizonte, Brazil, 30130-090

University of Oklahoma Health Science Center

Oklahoma City, United States, 73104

Site JP81005

Fukuoka, Japan

Toledo Clinic Cancer Center - Toledo

Toledo, United States, 43623

Site IT39022

Reggio Emilia, Italy, 42123

Site BE32005

Brugge, Belgium, 8310

University of Maryland Medical Center(UMMC)Transplant Center

Baltimore, United States, 21201

Site BR55006

Lajeado, Brazil, 95900000

Loma Linda University

Loma Linda, United States, 92354

Site TW88604

Kaohsiung, Taiwan, Province of China, 833

Site BE32011

Charleroi, Belgium, 6000

Site CO57006

Medellín, Colombia, 574

Site IT39026

Terni, Italy, 5100

Site IL97201

Haifa, Israel, 3109601

Seattle Cancer Care Alliance

Seattle, United States, 98109

Site DE49019

Heilbronn, Germany, 74078

Site PL48002

Brzozow, Poland, 36-20

University of California Davis

Sacramento, United States, 95817

Site CA15002

Montreal, Canada, H3T 1M5

Site IT39006

Milano, Italy, 20132

Site KR82003

Seoul, Republic of Korea, 03080

Site IT39013

Ancona, Italy, 60126

The University of Arizona Medical Center

Tucson, United States, 85724

Orlando Health Inc

Orlando, United States, 32806

Northwestern University Medical Center

Chicago, United States, 60611

Site BR55005

Sao Jose do Rio Preto, Brazil, 15090-000

Site MX52003

Distrito Federal, Mexico, 06720

Site PE51005

Lima, Peru, 15036

Site ES34017

Madrid, Spain, 28033

Site KR82007

Seoul, Republic of Korea, 152-703

Cancer Treatment Centers of America, Phoenix

Goodyear, United States, 85338

Site BE32010

Haine-Saint-Paul, Belgium, 7100

Site DE49012

Berlin, Germany, 13125

Site GB44103

Cambridge, United Kingdom, CB2 0QQ

Site FR33002

Paris cedex, France, 75970

Site DE49015

Magdeburg, Germany, 39104

Site IT39009

Cremona, Italy, 26100

Site FR33010

Brest Cedex, France, 29609

Site GB44001

Manchester, United Kingdom, M20 4BX

Site CN86008

Zhengzhou, China, 450000

Site PL48004

Lublin, Poland, 20-090

St Lukes Hospital Association of Duluth

Duluth, United States, 55805

Site IT39003

Piacenza, Italy, 29100

Site GB44009

Coventry, United Kingdom, CV2 2DX

Mount Sinai School of Medicine

New York, United States, 10029-6574

Regions Hospital

St. Paul, United States, 55101

Stony Brook University Medical Center

Stony Brook, United States, 11794-9452

Site TW88605

Kwei-Shan, Taiwan, Province of China, 333

Site GB44102

Sutton, United Kingdom, SM2 5PT

Site BR55010

Brasília, Brazil, 70200-730

Site ES34016

BARCELONA, Spain, 08025

Site CN86003

Haerbin, China, 150081

Site TW88601

Taipei, Taiwan, Province of China, 112

Site CL56003

Providencia, Chile, 7500921

Site IT39016

Padova, Italy, 35128

Site GB44006

Edinburgh, United Kingdom, EH4 2XU

Site CO57007

Monteria, Colombia, 230002

Karmanos Cancer Institute

Detroit, United States, 48201

Site CL56007

Valdivia, Chile, 5090000

Site FR33001

Rennes, France, 35042

Site CN86004

Hangzhou Shi, China, 310003

University of Colorado

Aurora, United States, 80045

Site CO57002

Medellin, Colombia, 0574

Site JP81008

Koto-ku, Japan

Site JP81010

Kitaadachi-gun, Japan

Memorial Sloan Kettering Cancer Center

Montvale, United States, 07645

Site FR33009

Dijon, France, 21079

Inova Dwight and Martha Schar Cancer Institute

Fairfax, United States, 22031

Site ES34013

Badalona, Spain, 08028

Site JP81009

Nagoya, Japan

Cancer Treatment Centers of America, Philadelphia

Philadelphia, United States, 19124

Site BR55002

Itajai, Brazil, 88301-220

Site DE49008

Munich, Germany, 81377

Site ES34008

Madrid, Spain, 28007

Site JP81003

Kashiwa, Japan

Site CO57001

Cali, Colombia

Site ES34019

Burgos, Spain, 09006

Site AU61006

East Bentleigh, Australia, 3165

Site JP81014

Kobe, Japan

Site IL97208

Petah-Tikva, Israel, 4941492

University of California - San Francisco

San Francisco, United States, 94143

Site IL97210

HaDarom, Israel, 7030000

Precision Cancer Research -Dayton Physicians Network

Middletown, United States, 45042

Memorial Cancer Institute - West

Hollywood, United States, 33021

Site CA15008

Montreal, Canada, H4A 3J1

Site FR33008

Besancon cedex, France, 25033

Site BE32012

Gent, Belgium, 9000

Site BR55007

Barretos, Brazil, 14784-400

Site BE32007

Edegem, Belgium, 2650

Site JP81004

Osaka, Japan

Earle A. Chiles Research Institute

Portland, United States, 97213

Site CN86006

Nanjing, China, 210008

Site DE49004

Leipzig, Germany, 04103

Site ES34018

Sevilla, Spain, 41009

Site KR82006

Seoul, Republic of Korea, 6591

Site GB44008

Leeds, United Kingdom, LS7 9TF

Site PE51004

San Isidro, Peru, L27

Site FR33003

Lyon, France, 69008

Site AU61007

Kogarah, Australia, 2217

Site MX52001

Aguascalientes, Mexico, 20230

Cancer Treatment Centers of America, Atlanta

Newman, United States, 30265

Site JP81006

Chuo-ku, Japan

The University of Texas MD Anderson Cancer Center

Houston, United States, 77030

Site CN86001

Xiamen, China

Site ES34006

Zaragoza, Spain, 50009

Site IT39018

Perugia, Italy, 05100

Site TW88607

Tainan, Taiwan, Province of China, 704

Site BE32001

Bruxelles, Belgium, 1200

Thomas Jefferson University

Philadelphia, United States, 19107

Site PL48001

Warszawa, Poland, 02-034

Site MX52002

Mexico, Mexico, 06760

Site IT39014

Bergamo, Italy, 24125

Site KR82008

Incheon, Republic of Korea, 21556

Site BR55009

São Paulo, Brazil, 01509-900

Health Partners Institute

St. Louis Park, United States, 55426

Mount Sinai School of Medicine

New York, United States, 10019-1147

Site BR55015

Rio de Janeiro, Brazil, 22793-080

Site IL97203

Tel Aviv, Israel, 64239

Sanford Cancer Center

Sioux Falls, United States, 57104

Site PE51003

Arequipa, Peru, 4001

Site IT39021

Modena, Italy, 41124

Site BR55004

São Paulo, Brazil, 08270-070

Lancaster General Hospital

Lancaster, United States, 17604

Site CA15005

Edmonton, Canada, T6G 1Z2

Site JP81002

Matsuyama, Japan

Site IT39024

Turin TO, Italy, 5-10126

CBCC Global Research, Inc. at Comprehensive Blood and Cancer

Bakersfield, United States, 93309

Memorial Sloan Kettering Cancer Center

Commack, United States, 11725

Site IT39019

Pisa, Italy, 56126

Site JP81015

Hidaka, Japan

Gene Upshaw Memorial Tahoe Forest Cancer Center - Pharmacy

Truckee, United States, 96161

Site IT39020

Monza, Italy, 20052

Site FR33103

Creteil, France, 94000

University of Arizona

Phoenix, United States, 85004

Massachusetts General Hospital

Boston, United States, 02114-2696

Site JP81013

Bunkyo-ku, Japan

Site CL56008

Providencia, Chile, 7520378

Site MX52004

Oaxaca, Mexico

Site BE32006

Leuven, Belgium, 3000

Site TW88603

Taichung, Taiwan, Province of China, 404

Site ES34010

Avila, Spain, 05004

Site DE49018

Dresden, Germany, 1067

Site JP81011

Osaka, Japan

Site KR82002

Seongnam-si, Republic of Korea, 13620

Site GB44101

London, United Kingdom, SW3 6JJ

Site PL48005

Wieliszew, Poland, 05-135

University of Chicago

Chicago, United States, 60637

Site JP81001

Suita, Japan

Site AU61011

Tugun, Australia, 4224

Site BE32004

Brussels, Belgium, 1000

Norton Cancer Institute

Louisville, United States, 40217

Site CA15009

Saint-John, Canada, E2L 4L4

Site IT39011

Meldola, Italy, 47014

Memorial Sloan Kettering Cancer Center

Basking Ridge, United States, 07920

Site PE51001

Lima, Peru, L27

Site IT39015

Roma, Italy, 00128

Site BE32008

Mons, Belgium, 7000

Memorial Hospital West

Pembroke Pines, United States, 33028

Site PL48007

Ostroleka, Poland, 07-410

University of Miami

Miami, United States, 33136

Site IT39012

Parma, Italy, 43126

Rhode Island Hospital-Lifespan Cancer Institute

Providence, United States, 02903

Site IT39004

Bergamo, Italy, 24127

Dana Farber Cancer Institute

Boston, United States, 02215

Site AU61002

Douglas, Australia, 4814

Site FR33007

Nice Cedex 2, France, 06189

Beth Israel Deaconess Medical Center

Boston, United States, 02215

Site FR33006

Poitiers, France, 86021

Site ES34003

Murcia, Spain, 30120

Site CO57005

Cali, Colombia

Site FR33011

Montpellier Cedex 5, France, 34298

Memorial Sloan Kettering Cancer Center

West Harrison, United States, 10604

Site FR33104

Saint Priest en Jarez, France, 42270

City of Hope Nat'l Medical Center

Duarte, United States, 91010

Memorial Sloan Kettering Cancer Center

Middletown, United States, 07748-3052

Site ES34011

Alcorcon, Spain, 28925

Site TW88606

Taipei, Taiwan, Province of China, 10002

The Ohio State University Medical Center

Columbus, United States, 43210

Roswell Park Cancer Institute

Buffalo, United States, 14263

The Angeles Clinic and Research Institute

Los Angeles, United States, 90025

Site GB44004

London, United Kingdom, W1G 6AD

Site ES34004

Madrid, Spain, 28034

Site FR33005

Nice, France, 06200

Memorial Sloan Kettering Cancer Center

Uniondale, United States, 11553

Memorial Sloan Kettering Cancer Center

New York, United States, 10065

Site IT39008

Milano, Italy, 20141

MultiCare Regional Cancer Center - Gig Harbor

Auburn, United States, 98801

St. Jude Hospital Yorba Linda

Fullerton, United States, 92835

Site KR82004

Seoul, Republic of Korea, 06351

The Valley Hospital

Paramus, United States, 07652

Site IT39023

Vicenza, Italy, 36100

Site CN86002

Beijing, China, 100071

Site DE49002

Mainz, Germany, 55101

Site BR55016

Passo Fundo, Brazil, 99010-260

Site KR82005

Seoul, Republic of Korea, 05505

Pacific Shores Medical Group

Huntington Beach, United States, 92648

Site ES34005

Barcelona, Spain, 08003

Site IL97209

Holon, Israel, 58100

Site IL97202

Jerusalem, Israel, 91031

Site BE32002

Bruxelles, Belgium, 1050

Site GB44003

Aberdeen, United Kingdom, AB25 2ZN

Site IL97206

Kfar Saba, Israel, 44281

Site CL56005

Santiago, Chile, 8330032

Site AU61008

Adelaide, Australia, 5011

Site ES34015

Barcelona, Spain, 08035

Site GB44002

London, United Kingdom, NW1 2PG

Site BR55018

Santa Catarina, Brazil, 88501-003

Site CN86005

Hefei, China, 230022

Maryland Oncology Hematology

Brandywine, United States, 20613

Site PE51006

Lima, Peru, 15072

Site CO57009

Bogota, Colombia, 110231

Site MX52008

San Luis de Potosi, Mexico, 78250

Site MX52009

Jalisco, Mexico, 45030

Site CA15011

Toronto, Canada, M5G 1X5

Site PL48009

Warszawa, Poland, 02-781

Site CN86009

Beijing, China, 100030

Site MX52007

Ciudad de México, Mexico, 3100

Site MX52010

Veracruz, Ver, Mexico, 91900

Site TW88609

Tainan, Taiwan, Province of China, 73657

Site TW88608

Kaohsiung, Taiwan, Province of China, 80756

Site DE49021

Halle, Germany, 06108