New drug combo shows promise against tough stomach cancer
NCT ID NCT03653507
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This study tests whether adding zolbetuximab (a drug that targets a protein called Claudin 18.2 found on many stomach tumors) to standard chemotherapy helps people with advanced stomach or gastroesophageal junction cancer live longer without their cancer growing. About 500 adults whose tumors have the Claudin 18.2 protein and have not spread to the brain or caused blockages in the gut will receive either zolbetuximab plus chemo or a placebo plus chemo. The main goal is to see if the drug combo delays cancer progression.
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
-
507 people
The number who actually took part.
- Started
-
Nov 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: * A female subject is eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin (βhCG) and a demonstrated non-pregnant status through additional testing are eligible) and at least 1 of the following conditions applies: * Not a woman of childbearing potential (WOCBP) OR * WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for 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 treatment 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 male subject with female partner(s) of childbearing potential: * must agree to use contraception during the treatment period and for 6 months after the final study treatment administration. * A male subject must not donate sperm during the treatment period and for 6 months after the final study treatment 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 treatment 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 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 or 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 (Hb) ≥ 9 g/dl. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb ≥ 9 g/dL. * Absolute Neutrophil Count (ANC) ≥ 1.5x10\^9/L * Platelets ≥ 100x10\^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/international normalized ratio (PT/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 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 treatment with herbal medications or other treatments that have known antitumor activity within 28 days prior to randomization. * 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 CAPOX. * Subject has known dihydropyrimidine dehydrogenase (DPD) 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 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 (CNS) 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 co-morbid 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Locally advanced unresectable gastric adenocarcinoma or cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
Houston Methodist Cancer Center and Institute of Academic Medicine - Oncology
Houston, Texas, 77030, United States
-
Montefiore Medical Center (MMC)
The Bronx, New York, 10467, United States
-
New Mexico Oncology Hematology
Albuquerque, New Mexico, 87109, United States
-
Ochsner Clinic CCOP
New Orleans, Louisiana, 70121, United States
-
Pacific Cancer Care
Monterey, California, 93940, United States
-
Parkland Hospital
Dallas, Texas, 75390, United States
-
Prisma Health Cancer Institute
Boiling Springs, South Carolina, 29316, United States
-
Site AR54001
San Miguel de Tucumán, Argentina
-
Site AR54003
Viedma, Argentina
-
Site AR54004
San Miguel de Tucumán, Argentina
-
Site AR54006
Pergamino, Argentina
-
Site AR54009
Buenos Aires, Argentina
-
Site CA15002
Rimouski, Quebec, Canada
-
Site CA15003
Chicoutimi, Quebec, Canada
-
Site CA15004
Calgary, Canada
-
Site CN86001
Guangzhou, China
-
Site CN86002
Changchun, China
-
Site CN86004
Wuhan, China
-
Site CN86005
Wuhan, China
-
Site CN86007
Hangzhou, Zhejiang, China
-
Site CN86009
Tianjin, China
-
Site CN86011
Xuzhou, China
-
Site CN86012
Zhengzhou, Henan, China
-
Site CN86013
Xi'an, China
-
Site CN86014
Shanghai, China
-
Site CN86015
Fuzhou, China
-
Site CN86016
Nanjing, China
-
Site CN86017
Shijiazhuang, China
-
Site CN86021
Changzhou, China
-
Site CN86024
Zhengzhou, China
-
Site CN86025
Bengbu, China
-
Site CN86026
Shantou, China
-
Site CN86027
Suzhou, Jiangsu, China
-
Site CN86029
Changsha, Hunan, China
-
Site CN86030
Xiamen, China
-
Site CN86031
Ürümqi, China
-
Site CN86032
Haikou, Hainan, China
-
Site CN86034
Fuzhou, Fujian, China
-
Site CN86035
Beijing, China
-
Site CN86036
Hangzhou, China
-
Site CN86037
Fuzhou, Fujian, China
-
Site CN86038
Linyi, China
-
Site CN86039
Chengdu, China
-
Site CN86040
Tianjin, China
-
Site CN86042
Guangzhou, China
-
Site CN86043
Hengyang, Hunan, China
-
Site CN86044
Baoding, China
-
Site CN86045
Nanning, China
-
Site CN86046
Wuxi, Jiangsu, China
-
Site CN86047
Shenyang, China
-
Site CN86049
Changchun, China
-
Site CN86050
Beijing, China
-
Site CN86051
Haebrin, China
-
Site CN86052
Dalian, China
-
Site CN86053
Changchun, China
-
Site CN86054
Dalian, China
-
Site ES34001
Elche, Spain
-
Site ES34002
Madrid, Spain
-
Site ES34003
Madrid, Spain
-
Site ES34004
Pamplona, Spain
-
Site ES34005
A Coruña, Spain
-
Site ES34006
Barcelona, Spain
-
Site ES34007
Valencia, Spain
-
Site ES34008
Madrid, Spain
-
Site ES34009
Barcelona, Spain
-
Site ES34010
Barcelona, Spain
-
Site ES34011
Málaga, Spain
-
Site ES34012
Valencia, Spain
-
Site ES34013
Madrid, Spain
-
Site GB44001
London, United Kingdom
-
Site GB44002
Bristol, United Kingdom
-
Site GB44004
Cardiff, United Kingdom
-
Site GB44005
Northwood, Argentina
-
Site GR30001
Athens, Greece
-
Site GR30002
Thessaloniki, Greece
-
Site GR30003
Larissa, Greece
-
Site GR30004
Heraklion, Greece
-
Site GR30005
Neo Faliro, Piraeus, Greece
-
Site GR30007
Rio Patras, Greece
-
Site GR3006
Thessaloniki, Greece
-
Site HR38501
Varaždin, Croatia
-
Site HR38502
Zagreb, Croatia
-
Site HR38503
Zagreb, Croatia
-
Site IE35301
Dublin, Ireland
-
Site IE35302
Dublin, Ireland
-
Site JP81001
Yokohama, Kanagawa, Japan
-
Site JP81002
Chiba, Japan
-
Site JP81003
Kawasaki, Kanagawa, Japan
-
Site JP81004
Kita-gun, Japan
-
Site JP81005
Utsunomiya, Tochigi, Japan
-
Site JP81006
Kashiwa, Japan
-
Site JP81007
Fukuoka, Fukuoka, Japan
-
Site JP81008
Akashi, Hyōgo, Japan
-
Site JP81009
Matsuyama, Japan
-
Site JP81010
Suita, Osaka, Japan
-
Site JP81011
Tsukiji, Japan
-
Site JP81012
Kōtoku, Japan
-
Site KR82001
Seoul, South Korea
-
Site KR82002
Daegu, South Korea
-
Site KR82003
Seoul, South Korea
-
Site KR82006
Goyang-si, South Korea
-
Site KR82007
Gyeonggi-do, South Korea
-
Site KR82008
Jeollanam-do, South Korea
-
Site KR82009
Suwon, South Korea
-
Site KR82010
Jeonju, South Korea
-
Site KR82011
Seongnam-si, South Korea
-
Site KR82012
Seoul, South Korea
-
Site KR82013
Seoul, South Korea
-
Site KR82014
Incheon, South Korea
-
Site KR82015
Seoul, South Korea
-
Site MY60001
George Town, Malaysia
-
Site MY60002
Kuala Lumpur, Malaysia
-
Site MY60003
Kuala Lumpur, Malaysia
-
Site MY60004
Kota Kinabalu, Malaysia
-
Site MY60005
Kuala Lumpur, Malaysia
-
Site NL31003
Tilburg, Netherlands
-
Site NL31004
Groningen, Netherlands
-
Site PT35101
Setúbal, Portugal
-
Site PT35102
Lisbon, Portugal
-
Site PT35104
Santa Maria da Feira, Portugal
-
Site PT35105
Porto, Portugal
-
Site PT35106
Lisbon, Portugal
-
Site PT35107
Vila Real, Portugal
-
Site PT35108
Porto, Portugal
-
Site PT35109
Braga, Portugal
-
Site PT35110
Coimbra, Portugal
-
Site PT35111
Guimarães, Portugal
-
Site RO40001
Iași, Romania
-
Site RO40002
Bucharest, Romania
-
Site RO40003
Craiova, Romania
-
Site RO40004
Floreşti, Romania
-
Site RO40005
Cluj-Napoca, Romania
-
Site RO40006
Iași, Romania
-
Site RO40007
Cluj-Napoca, Romania
-
Site RO40008
Timișoara, Romania
-
Site TH66001
Muang, Thailand
-
Site TH66002
Bangkok, Thailand
-
Site TH66003
Muang, Thailand
-
Site TH66004
Songkhla, Thailand
-
Site TH66005
Bangkok, Thailand
-
Site TH66006
Pathum Thani, Thailand
-
Site TH66007
Bangkok, Thailand
-
Site TH66008
Vadhana, Thailand
-
Site TH66009
Bangkok, Thailand
-
Site TH66010
Pathumwan, Thailand
-
Site TH66011
Laksi, Thailand
-
Site TR90001
Bursa, Turkey (Türkiye)
-
Site TR90002
Istanbul, Turkey (Türkiye)
-
Site TR90003
Atakum, Turkey (Türkiye)
-
Site TR90004
Balcalı, Turkey (Türkiye)
-
Site TR90007
Konya, Turkey (Türkiye)
-
Site TR90008
Pendik, Istanbul, Turkey (Türkiye)
-
Site TR90010
Istanbul, Turkey (Türkiye)
-
Site TR90011
Malatya, Turkey (Türkiye)
-
Site TR90012
Bornova, Turkey (Türkiye)
-
Site TR90013
Konyaalti, Turkey (Türkiye)
-
Site TR90015
Istanbul, Turkey (Türkiye)
-
Site TW88602
Kaohsiung City, Taiwan
-
Site TW88603
Taichung, Taiwan
-
Site TW88604
Taipei, Taiwan
-
Site TW88605
Tianan, Taiwan
-
University of Kansas Cancer Center and Medical Pavilion
Fairway, Kansas, 66205, United States
-
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
-
Utah Cancer Specialist
Salt Lake City, Utah, 84106, United States
-
Weill Cornell Medical College (WCMC)
New York, New York, 10021, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.