New Antibody-Chemo combo shows promise in slowing stomach cancer
NCT ID NCT03504397
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tests whether adding zolbetuximab, an antibody that targets the Claudin 18.2 protein found on many stomach tumors, to standard chemotherapy can delay cancer progression in people with advanced stomach or gastroesophageal junction cancer. About 565 adults whose cancer has spread and cannot be surgically removed will receive either zolbetuximab plus chemo or a placebo plus chemo. The study is double-blind, so neither patients nor doctors know who gets the active drug. The main goal is to see if the combination extends the time before the cancer worsens.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- zolbetuximab (a targeted antibody) plus chemotherapy (mFOLFOX6)
- What this could lead to
- If successful, this could provide a new first-line treatment option for people with advanced stomach or GEJ cancer that has a specific protein (Claudin 18.2), potentially slowing cancer growth and extending survival.
- What could go wrong
- This is an early-stage Phase 3 trial, and results may not confirm benefit. The treatment requires ongoing chemotherapy and may cause side effects like infusion reactions or gut issues. It is not a cure, and patients will still need long-term management.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
565 people
The number who actually took part.
- Started
-
Jun 2018
- Expected to finish
-
Sep 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Female subject eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin and a demonstrated non-pregnant status through additional testing are eligible) and at least one of the following conditions applies: * Not a woman of child-bearing potential (WOCBP) OR * WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs * Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration. * Female subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs. * A sexually active male subject with a female partner(s) who is of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration. * Male subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration. * Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration. * Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma. * Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization. * Subject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, ≤ 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy. * Subject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing. * Subject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen. (Unique to China: Subject has a known HER2-negative gastric or GEJ tumor.) * Subject has ECOG performance status 0 to 1. * Subject has predicted life expectancy ≥ 12 weeks. * Subject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility. * Hemoglobin (Hgb) ≥ 9 g/dL. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb ≥ 9 g/dL. * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L * Platelets ≥ 100 x 10\^9/L * Albumin ≥ 2.5 g/dL * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) without liver metastases (or \< 3.0 x ULN if liver metastases are present) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (or ≤ 5 x ULN if liver metastases are present) * Estimated creatinine clearance ≥ 30 mL/min * Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy) Exclusion Criteria: * Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies, as long as it was completed at least 6 months prior to randomization. Subject may have received treatment with herbal medications that have known antitumor activity \> 28 days prior to randomization. * Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma ≤ 14 days prior to randomization and has not recovered from any related toxicity. * Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed. * Subject has received other investigational agents or devices within 28 days prior to randomization. * Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies. * Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment. * Subject has prior severe allergic reaction or intolerance to any component of mFOLFOX6. * Subject has known dihydropyrimidine dehydrogenase deficiency. * Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting. * Subject has significant gastric bleeding and/or untreated gastric ulcers that would exclude the subject from participation. * Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen (HBs Ag)) or C infection. NOTE: Screening for these infections should be conducted per local requirements. * For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab) positive, an HB deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded. * Subjects with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test are eligible. * Subjects treated for HCV with undetectable viral load results are eligible. * Subject has an active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization. * Subject has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization. * Subject has significant cardiovascular disease, including any of the following: * Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident (CVA) or hypertensive crisis within 6 months prior to randomization. * History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes) * QTc interval \> 450 msec for male subjects; QTc interval \> 470 msec for female subjects * History or family history of congenital long QT syndrome * Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for \> 1 month prior to randomization are eligible). * Subject has a history of central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ cancer. * Subject has known peripheral sensory neuropathy \> Grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality. * Subject has had a major surgical procedure ≤ 28 days prior to randomization. * Subject is without complete recovery from a major surgical procedure ≤ 14 days prior to randomization. * Subject has psychiatric illness or social situations that would preclude study compliance. * Subject has another malignancy for which treatment is required. * Subject has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
-
CBCC Global Research, Inc. at Comprehensive Blood and Cancer
Bakersfield, California, 93309, United States
-
Cancer Treatment Centers of America, Atlanta
Newnan, Georgia, 30265, United States
-
Cancer Treatment Centers of America, Philadelphia
Philadelphia, Pennsylvania, 19124, United States
-
City of Hope Nat'l Medical Center
Duarte, California, 91010, United States
-
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
-
Earle A. Chiles Research Institute
Portland, Oregon, 97213, United States
-
Health Partners Institute
Saint Louis Park, Minnesota, 55426, United States
-
Inova Dwight and Martha Schar Cancer Institute
Fairfax, Virginia, 22031, United States
-
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
-
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
-
Loma Linda University
Loma Linda, California, 92354, United States
-
Maryland Oncology Hematology
Brandywine, Maryland, 20613, United States
-
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696, United States
-
Memorial Cancer Institute - West
Hollywood, Florida, 33021, United States
-
Memorial Hospital West
Pembroke Pines, Florida, 33028, United States
-
Memorial Sloan Kettering Cancer Center
Middletown, Connecticut, 07748-3052, United States
-
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, 07920, United States
-
Memorial Sloan Kettering Cancer Center
Montvale, New Jersey, 07645, United States
-
Memorial Sloan Kettering Cancer Center
Commack, New York, 11725, United States
-
Memorial Sloan Kettering Cancer Center
Harrison, New York, 10604, United States
-
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
-
Memorial Sloan Kettering Cancer Center
Uniondale, New York, 11553, United States
-
Mount Sinai School of Medicine
New York, New York, 10029-6574, United States
-
MultiCare Regional Cancer Center - Gig Harbor
Auburn, Washington, 98801, United States
-
Northwestern University Medical Center
Chicago, Illinois, 60611, United States
-
Norton Cancer Institute
Louisville, Kentucky, 40217, United States
-
Oregon Health & Science University
Portland, Oregon, 97239, United States
-
Orlando Health Inc
Orlando, Florida, 32806, United States
-
Pacific Shores Medical Group
Huntington Beach, California, 92648, United States
-
Precision Cancer Research -Dayton Physicians Network
Middletown, Ohio, 45042, United States
-
Regions Hospital
Saint Paul, Minnesota, 55101, United States
-
Rhode Island Hospital-Lifespan Cancer Institute
Providence, Rhode Island, 02903, United States
-
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
-
Sanford Cancer Center
Sioux Falls, South Dakota, 57104, United States
-
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
-
Site AU61002
Douglas, Queensland, 4814, Australia
-
Site AU61006
East Bentleigh, Victoria, 3165, Australia
-
Site AU61007
Kogarah, 2217, Australia
-
Site AU61008
Adelaide, South Australia, 5011, Australia
-
Site AU61011
Tugun, Queensland, 4224, Australia
-
Site BE32001
Brussels, Bruxelles-Capitale, Région de, 1200, Belgium
-
Site BE32002
Brussels, Liege, 1050, Belgium
-
Site BE32004
Brussels, 1000, Belgium
-
Site BE32005
Bruges, 8310, Belgium
-
Site BE32006
Leuven, Vlaams Brabant, 3000, Belgium
-
Site BE32007
Edegem, Antwerpen, 2650, Belgium
-
Site BE32008
Mons, Hainaut, 7000, Belgium
-
Site BE32010
Haine-Saint-Paul, 7100, Belgium
-
Site BE32011
Charleroi, 6000, Belgium
-
Site BE32012
Ghent, Oost-Vlaanderen, 9000, Belgium
-
Site BR55002
Itajaí, Santa Catarina, 88301-220, Brazil
-
Site BR55003
Santo André, São Paulo, 09060-650, Brazil
-
Site BR55004
São Paulo, 08270-070, Brazil
-
Site BR55005
São José do Rio Preto, São Paulo, 15090-000, Brazil
-
Site BR55006
Lajeado, Rio Grande do Sul, 95900000, Brazil
-
Site BR55007
Barretos, São Paulo, 14784-400, Brazil
-
Site BR55009
São Paulo, 01509-900, Brazil
-
Site BR55010
Brasília, Federal District, 70200-730, Brazil
-
Site BR55015
Rio de Janeiro, 22793-080, Brazil
-
Site BR55016
Passo Fundo, 99010-260, Brazil
-
Site BR55017
Belo Horizonte, 30130-090, Brazil
-
Site BR55018
Santa Catarina, 88501-003, Brazil
-
Site CA15002
Montreal, Quebec, H3T 1M5, Canada
-
Site CA15005
Edmonton, Alberta, T6G 1Z2, Canada
-
Site CA15008
Montreal, Quebec, H4A 3J1, Canada
-
Site CA15009
Saint John, New Brunswick, E2L 4L4, Canada
-
Site CA15011
Toronto, Ontario, M5G 1X5, Canada
-
Site CL56003
Providencia, Santiago Metropolitan, 7500921, Chile
-
Site CL56005
Santiago, 8330032, Chile
-
Site CL56007
Valdivia, 5090000, Chile
-
Site CL56008
Providencia, 7520378, Chile
-
Site CN86001
Xiamen, China
-
Site CN86002
Beijing, 100071, China
-
Site CN86003
Haerbin, Heilongjiang, 150081, China
-
Site CN86004
Hangzhou, Zhejiang, 310003, China
-
Site CN86005
Hefei, 230022, China
-
Site CN86006
Nanjing, Jiangsu, 210008, China
-
Site CN86008
Zhengzhou, 450000, China
-
Site CN86009
Beijing, 100030, China
-
Site CO57001
Cali, Colombia
-
Site CO57002
Medellín, 0574, Colombia
-
Site CO57005
Cali, Valle del Cauca Department, Colombia
-
Site CO57006
Medellín, Antioquia, 574, Colombia
-
Site CO57007
Montería, Departamento de Córdoba, 230002, Colombia
-
Site CO57009
Bogotá, DC, 110231, Colombia
-
Site DE49002
Mainz, Rhineland-Palatinate, 55101, Germany
-
Site DE49004
Leipzig, Saxony, 04103, Germany
-
Site DE49007
München, Bavaria, 81925, Germany
-
Site DE49008
Munich, Bavaria, 81377, Germany
-
Site DE49010
Dresden, Saxony, 01307, Germany
-
Site DE49011
Berlin, 13353, Germany
-
Site DE49012
Berlin, 13125, Germany
-
Site DE49015
Magdeburg, Saxony-Anhalt, 39104, Germany
-
Site DE49018
Dresden, 1067, Germany
-
Site DE49019
Heilbronn, 74078, Germany
-
Site DE49021
Halle, Saxony-Anhalt, 06108, Germany
-
Site ES34003
Murcia, 30120, Spain
-
Site ES34004
Madrid, 28034, Spain
-
Site ES34005
Barcelona, 08003, Spain
-
Site ES34006
Zaragoza, 50009, Spain
-
Site ES34008
Madrid, 28007, Spain
-
Site ES34010
Ávila, Castille and León, 05004, Spain
-
Site ES34011
Alcorcón, Madrid, 28925, Spain
-
Site ES34013
Badalona, Barcelona, 08028, Spain
-
Site ES34015
Barcelona, 08035, Spain
-
Site ES34016
Barcelona, 08025, Spain
-
Site ES34017
Madrid, 28033, Spain
-
Site ES34018
Seville, 41009, Spain
-
Site ES34019
Burgos, 09006, Spain
-
Site FR33001
Rennes, Brittany Region, 35042, France
-
Site FR33002
Paris, Paris, 75970, France
-
Site FR33003
Lyon, Rhone, 69008, France
-
Site FR33005
Nice, Provence-Alpes-Côte d'Azur Region, 06200, France
-
Site FR33006
Poitiers, Vienne, 86021, France
-
Site FR33007
Nice, 06189, France
-
Site FR33008
Besançon, Franche-Comte, 25033, France
-
Site FR33009
Dijon, Bourgogne-Franche-Comté, 21079, France
-
Site FR33010
Brest, Brittany Region, 29609, France
-
Site FR33011
Montpellier, Languedoc-Roussillon, 34298, France
-
Site FR33101
Saint-Herblain, Pays de la Loire Region, 44805, France
-
Site FR33103
Créteil, 94000, France
-
Site FR33104
Saint-Priest-en-Jarez, 42270, France
-
Site GB44001
Manchester, M20 4BX, United Kingdom
-
Site GB44002
London, NW1 2PG, United Kingdom
-
Site GB44003
Aberdeen, Aberdeenshire, AB25 2ZN, United Kingdom
-
Site GB44004
London, W1G 6AD, United Kingdom
-
Site GB44008
Leeds, LS7 9TF, United Kingdom
-
Site GB44009
Coventry, CV2 2DX, United Kingdom
-
Site GB44101
London, London, City of, SW3 6JJ, United Kingdom
-
Site GB44102
Sutton, Surrey, SM2 5PT, United Kingdom
-
Site GB44103
Cambridge, CB2 0QQ, United Kingdom
-
Site GB44104
Dundee, DD2 4BF, United Kingdom
-
Site IL97201
Haifa, 3109601, Israel
-
Site IL97202
Jerusalem, 91031, Israel
-
Site IL97203
Tel Aviv, 64239, Israel
-
Site IL97206
Kfar Saba, Central District, 44281, Israel
-
Site IL97209
Holon, 58100, Israel
-
Site IL97210
HaDarom, 7030000, Israel
-
Site IT39003
Piacenza, 29100, Italy
-
Site IT39004
Bergamo, 24127, Italy
-
Site IT39006
Milan, 20132, Italy
-
Site IT39008
Milan, 20141, Italy
-
Site IT39009
Cremona, 26100, Italy
-
Site IT39011
Meldola, Forli, 47014, Italy
-
Site IT39012
Parma, 43126, Italy
-
Site IT39013
Ancona, 60126, Italy
-
Site IT39015
Roma, 00128, Italy
-
Site IT39016
Padova, 35128, Italy
-
Site IT39018
Perugia, 05100, Italy
-
Site IT39019
Pisa, 56126, Italy
-
Site IT39020
Monza, Lombardy, 20052, Italy
-
Site IT39021
Modena, 41124, Italy
-
Site IT39022
Reggio Emilia, 42123, Italy
-
Site IT39023
Vicenza, VI, 36100, Italy
-
Site IT39024
Turin to, 5-10126, Italy
-
Site IT39026
Terni, 5100, Italy
-
Site JP81001
Suita, Osaka, Japan
-
Site JP81002
Matsuyama, Ehime, Japan
-
Site JP81003
Kashiwa, Chiba, Japan
-
Site JP81004
Osaka, Japan
-
Site JP81005
Fukuoka, Japan
-
Site JP81006
Chuo-ku, Tokyo, Japan
-
Site JP81007
Sapporo, Hokkaido, Japan
-
Site JP81008
Koto-ku, Tokyo, Japan
-
Site JP81009
Nagoya, Aichi-ken, Japan
-
Site JP81010
Kitaadachi-gun, Saitama, Japan
-
Site JP81011
Osaka, Japan
-
Site JP81012
Sunto-gun, Shizuoka, Japan
-
Site JP81013
Bunkyo-ku, Tokyo, Japan
-
Site JP81014
Kobe, Hyōgo, Japan
-
Site JP81015
Hidaka, Saitama, Japan
-
Site KR82002
Seongnam-si, Gyeonggi-do, 13620, South Korea
-
Site KR82003
Seoul, 03080, South Korea
-
Site KR82004
Seoul, Seoul Teugbyeolsi, 06351, South Korea
-
Site KR82005
Seoul, 05505, South Korea
-
Site KR82006
Seoul, 6591, South Korea
-
Site KR82007
Seoul, 152-703, South Korea
-
Site KR82008
Incheon, 21556, South Korea
-
Site KR82009
Suwon, Gyeonggido [Kyonggi-do], 16247, South Korea
-
Site MX52001
Aguascalientes, 20230, Mexico
-
Site MX52002
Mexico City, Mexico City, 06760, Mexico
-
Site MX52003
Distrito Federal, 06720, Mexico
-
Site MX52004
Oaxaca City, Mexico
-
Site MX52007
Mexico City, Mexico City, 3100, Mexico
-
Site MX52008
San Luis de Potosi, 78250, Mexico
-
Site MX52009
Jalisco, 45030, Mexico
-
Site MX52010
Veracruz, Ver, Veracruz, 91900, Mexico
-
Site PE51001
Lima, L27, Peru
-
Site PE51003
Arequipa, 4001, Peru
-
Site PE51004
San Isidro, Lima region, L27, Peru
-
Site PE51005
Lima, 15036, Peru
-
Site PE51006
Lima, 15072, Peru
-
Site PL48002
Brzozów, Podkarpackie Voivodeship, 36-20, Poland
-
Site PL48004
Lublin, Lubusz Voivodeship, 20-090, Poland
-
Site PL48005
Wieliszew, Masovian Voivodeship, 05-135, Poland
-
Site PL48007
Ostrołęka, Masovian Voivodeship, 07-410, Poland
-
Site PL48009
Warsaw, 02-781, Poland
-
Site TW88601
Taipei, 112, Taiwan
-
Site TW88603
Taichung, 404, Taiwan
-
Site TW88604
Kaohsiung City, 833, Taiwan
-
Site TW88605
Kwei-Shan, Taoyuan, 333, Taiwan
-
Site TW88606
Taipei, 10002, Taiwan
-
Site TW88607
Tainan, 704, Taiwan
-
Site TW88608
Kaohsiung City, 80756, Taiwan
-
St. Jude Hospital Yorba Linda
Fullerton, California, 92835, United States
-
Stony Brook University Medical Center
Stony Brook, New York, 11794-9452, United States
-
The Angeles Clinic and Research Institute
Los Angeles, California, 90025, United States
-
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
-
The University of Arizona Medical Center
Tucson, Arizona, 85724, United States
-
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
-
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
-
University of Arizona
Phoenix, Arizona, 85004, United States
-
University of California - San Francisco
San Francisco, California, 94143, United States
-
University of California Davis
Sacramento, California, 95817, United States
-
University of Chicago
Chicago, Illinois, 60637, United States
-
University of Colorado
Aurora, Colorado, 80045, United States
-
University of Maryland Medical Center(UMMC)Transplant Center
Baltimore, Maryland, 21201, United States
-
University of Miami
Miami, Florida, 33136, United States
-
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
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