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A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX 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 (GLOW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653507
Recruitment Status : Active, not recruiting
First Posted : August 31, 2018
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief Summary:

The purpose of this study is to evaluate the efficacy of zolbetuximab plus capecitabine and oxaliplatin (CAPOX) compared with placebo plus CAPOX (as first-line treatment) as measured by Progression Free Survival (PFS).

This study will also evaluate efficacy, physical function, safety, and tolerability of zolbetuximab, as well as its effects on quality of life. Pharmacokinetics (PK) of zolbetuximab and the immunogenicity profile of zolbetuximab will be evaluated as well.


Condition or disease Intervention/treatment Phase
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer Metastatic Gastric Adenocarcinoma or Cancer Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma Drug: zolbetuximab Drug: oxaliplatin Drug: capecitabine Drug: placebo Phase 3

Detailed Description:
The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 507 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX 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
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A (zolbetuximab plus CAPOX)
Participants will receive a loading dose of zolbetuximab at Cycle 1 Day 1 followed by a lower dose in subsequent cycles every 3 weeks. Additionally, participants will receive CAPOX (capecitabine/oxaliplatin) treatment until IRC confirmed disease progression or a total of 8 treatments (each cycle is defined as 3 weeks = approximately 21 days). Oxaliplatin is administered on day 1 of each cycle, whereas capecitabine is taken twice daily on days 1 through 14. After a maximum of 8 treatments of Oxaplatin, subjects may continue to receive capecitabine twice daily on days 1 through 14 of each cycle at the investigator's discretion until the subject meets study treatment discontinuation criteria.
Drug: zolbetuximab
Zolbetuximab will be administered as a minimum 2-hour IV infusion.
Other Name: IMAB362

Drug: oxaliplatin
Oxaliplatin will be administered as a 2-hour IV infusion.

Drug: capecitabine
Capecitabine will be administered orally twice daily (bid).

Placebo Comparator: Arm B (placebo plus CAPOX)
Participants will receive placebo starting at Cycle 1 Day 1 and every 3 weeks thereafter. Additionally, participants will receive CAPOX (capecitabine/oxaliplatin) treatment until IRC confirmed disease progression or a total of 8 treatments (each cycle is defined as 3 weeks = approximately 21 days). Oxaliplatin is administered on day 1 of each cycle, whereas capecitabine is taken twice daily on days 1 through 14. After a maximum of 8 treatments of Oxaplatin, subjects may continue to receive capecitabine twice daily on days 1 through 14 of each cycle at the investigator's discretion until the subject meets study treatment discontinuation criteria.
Drug: oxaliplatin
Oxaliplatin will be administered as a 2-hour IV infusion.

Drug: capecitabine
Capecitabine will be administered orally twice daily (bid).

Drug: placebo
Placebo will be administered as a minimum 2-hour IV infusion.




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: up to 13 months ]
    PFS is defined as the time from the date of randomization until the date of radiological progressive disease (per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by Independent Review Committee (IRC)) or death from any cause, whichever is earliest.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: up to 23 months ]
    OS is defined as the time from the date of randomization until the date of death from any cause.

  2. Time to confirmed deterioration (TTCD) in participant-reported physical functioning and Global Health Status/Quality of Life (GHS/QoL) [ Time Frame: Up to 16 months ]
    TTCD is measured by EORTC QLQ-C30 and QLQ-OG25 plus STO22 Belching subscale and defined as time to first confirmed deterioration; that is, time from randomization to first clinically meaningful deterioration that is confirmed at the next scheduled visit.

  3. Objective Response Rate (ORR) [ Time Frame: up to 13 months ]
    ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by Independent Review Committee (IRC) per RECIST 1.1.

  4. Duration Of Response (DOR) [ Time Frame: up to 13 months ]
    DOR, defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by IRC per RECIST 1.1 or date of death from any cause, whichever is earliest.

  5. Safety and tolerability assessed by adverse events (AEs) [ Time Frame: up to 16 months ]
    An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  6. Number of participants with laboratory assessments abnormalities and or adverse events [ Time Frame: up to 14 months ]
    Number of participants with potentially clinically significant laboratory values.

  7. Number of participants with vital signs abnormalities and or adverse events [ Time Frame: up to 14 months ]
    Number of participants with potentially clinically significant vital sign values.

  8. Number of participants with electrocardiograms (ECG) abnormalities and or adverse events [ Time Frame: up to 14 months ]
    Number of participants with potentially clinically significant ECG values.

  9. Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events [ Time Frame: up to 13 months ]
    Number of participants with potentially clinically significant ECOG performance status values. ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair and 5 = Dead.

  10. Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC-QLQ-C30) [ Time Frame: up to 16 months ]
    EORTC-QLQ-C30 is a cancer-specific 30-item questionnaire. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.

  11. Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Oesophago-Gastric Module 25 (QLQ-OG25) questionnaire plus EORTC-QLQ-STO22 Belching subscale [ Time Frame: up to 16 months ]
    The EORTC-QLQ-OG25 instrument evaluates Gastric and Gastroesophageal Junction (GEJ) cancer-specific symptoms such as stomach discomfort, difficulties eating and swallowing and indigestion. It is a 25-item questionnaire. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much". To ensure relevant symptoms are adequately covered two questions from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach (EORTC-QLQ-STO22) instrument related to belching and bile or acid coming in your mouth will be asked following the OG25 questionnaire. Participants rate items on a 4 point scale, with 1 as "not at all" and 4 as "very much". The total and subscale scores from the OG25 and item scores from the STO22 items will be reported.

  12. Health Related Quality of Life (HRQoL) measured by the Global Pain (GP) questionnaire [ Time Frame: up to 16 months ]
    The GP instrument is a single assessment of overall pain where 0 equals no pain and 10 equals extreme pain. Low pain scores are considered a better outcome than a high pain score.

  13. Health Related Quality of Life (HRQoL) measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) questionnaire [ Time Frame: up to 16 months ]
    The EQ-5D-5L is a standardized instrument developed by the EuroQol Group for use as a generic, preference-based measure of health outcomes. The EQ-5D-5L is a 5-item self-reported measure of functioning and wellbeing, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). A unique EQ-5D-5L health state is defined by combining 1 level from each of the 5 dimensions. This questionnaire also records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples.

  14. Pharmacokinetics (PK) of zolbetuximab: Concentration Immediately Prior to Dosing at multiple dosing (Ctrough) [ Time Frame: up to 16 months ]
    Ctrough will be derived from the PK serum samples collected.

  15. Number of anti-drug antibody (ADA) Positive Participants [ Time Frame: up to 16 months ]
    Immunogenicity will be measured by the number of participants that are ADA positive.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653507


Locations
Hide Hide 166 study locations
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United States, California
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Pacific Cancer Care
Monterey, California, United States, 93940
United States, Kansas
University of Kansas Cancer Center and Medical Pavilion
Fairway, Kansas, United States, 66205
United States, Louisiana
Ochsner Clinic CCOP
New Orleans, Louisiana, United States, 70121
United States, New Mexico
New Mexico Oncology Hematology
Albuquerque, New Mexico, United States, 87109
United States, New York
Montefiore Medical Center (MMC)
Bronx, New York, United States, 10467
Weill Cornell Medical College (WCMC)
New York, New York, United States, 10021
United States, South Carolina
Prisma Health Cancer Institute
Boiling Springs, South Carolina, United States, 29316
United States, Texas
Parkland Hospital
Dallas, Texas, United States, 75390
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Houston Methodist Cancer Center and Institute of Academic Medicine - Oncology
Houston, Texas, United States, 77030
United States, Utah
Utah Cancer Specialist
Salt Lake City, Utah, United States, 84106
Argentina
Site AR54009
Buenos Aires, Argentina
Site AR54008
Córdoba, Argentina
Site AR54006
Pergamino, Argentina
Site AR54001
San Miguel De Tucuman, Argentina
Site AR54004
San Miguel de Tucumán, Argentina
Site AR54003
Viedma, Argentina
Canada, Quebec
Site CA15003
Chicoutimi, Quebec, Canada
Site CA15002
Rimouski, Quebec, Canada
Canada
Site CA15004
Calgary, Canada
China, Fujian
Site CN86034
Fuzhou, Fujian, China
Site CN86037
Fuzhou, Fujian, China
China, Hainan
Site CN86032
Haikou, Hainan, China
China, Henan
Site CN86012
Zhengzhou, Henan, China
China, Hunan
Site CN86029
Changsha, Hunan, China
Site CN86043
Hengyang, Hunan, China
China, Jiangsu
Site CN86027
Suzhou, Jiangsu, China
Site CN86046
Wuxi, Jiangsu, China
China, Zhejiang
Site CN86007
Hangzhou, Zhejiang, China
China
Site CN86044
Baoding, China
Site CN86035
Beijing, China
Site CN86050
Beijing, China
Site CN86025
Bengbu, China
Site CN86002
Changchun, China
Site CN86049
Changchun, China
Site CN86053
Changchun, China
Site CN86021
Changzhou, China
Site CN86039
Chengdu, China
Site CN86052
Dalian, China
Site CN86054
Dalian, China
Site CN86015
Fuzhou, China
Site CN86001
Guangzhou, China
Site CN86028
Guangzhou, China
Site CN86042
Guangzhou, China
Site CN86051
Haebrin, China
Site CN86036
Hangzhou, China
Site CN86038
Linyi, China
Site CN86016
Nanjing, China
Site CN86045
Nanning, China
Site CN86014
Shanghai, China
Site CN86026
Shantou, China
Site CN86047
Shenyang, China
Site CN86017
Shijiazhuang, China
Site CN86009
Tianjin, China
Site CN86040
Tianjin, China
Site CN86031
Urumchi, China
Site CN86004
Wuhan, China
Site CN86005
Wuhan, China
Site CN86013
Xi'an, China
Site CN86030
Xiamen, China
Site CN86011
Xuzhou, China
Site CN86024
Zhengzhou, China
Croatia
Site HR38501
Varazdin, Croatia
Site HR38502
Zagreb, Croatia
Site HR38503
Zagreb, Croatia
Greece
Site GR30001
Athens, Greece
Site GR30004
Heraklion, Greece
Site GR30003
Larissa, Greece
Site GR30005
Neo Faliro, Piraeus, Greece
Site GR30007
Rio Patras, Greece
Site GR30002
Thessaloniki, Greece
Site GR30006
Thessaloniki, Greece
Ireland
Site IE35302
Dublin, Ireland
Japan
Site JP81007
Fukuoka-shi, Fukuoka, Japan
Site JP81008
Akashi, Hyogo, Japan
Site JP81004
Kita-gun, Kagawa, Japan
Site JP81003
Kawasaki, Kanagawa, Japan
Site JP81001
Yokohama, Kanagawa, Japan
Site JP81010
Suita, Osaka, Japan
Site JP81005
Utsunomiya, Tochigi, Japan
Site JP81002
Chiba, Japan
Site JP81006
Kashiwa, Japan
Site JP81012
Koto-ku, Japan
Site JP81009
Matsuyama, Japan
Site JP81011
Tsukiji, Japan
Korea, Republic of
Site KR82002
Daegu, Korea, Republic of
Site KR82006
Goyang-si, Korea, Republic of
Site KR82007
Gyeonggi-do, Korea, Republic of
Site KR82014
Incheon, Korea, Republic of
Site KR82008
Jeollanam-do, Korea, Republic of
Site KR82010
Jeonju-si, Korea, Republic of
Site KR82011
Seongnam-si, Korea, Republic of
Site KR82001
Seoul, Korea, Republic of
Site KR82003
Seoul, Korea, Republic of
Site KR82012
Seoul, Korea, Republic of
Site KR82013
Seoul, Korea, Republic of
Site KR82009
Suwon, Korea, Republic of
Malaysia
Site MY60001
Georgetown, Malaysia
Site MY60004
Kota Kinabalu, Malaysia
Site MY60002
Kuala Lumpur, Malaysia
Site MY60003
Kuala Lumpur, Malaysia
Site MY60005
Kuala Lumpur, Malaysia
Netherlands
Site NL31004
Groningen, Netherlands
Site NL31003
Tilburg, Netherlands
Portugal
Site PT35109
Braga, Portugal
Site PT35110
Coimbra, Portugal
Site PT35111
Guimaraes, Portugal
Site PT35102
Lisboa, Portugal
Site PT35106
Lisboa, Portugal
Site PT35105
Porto, Portugal
Site PT35108
Porto, Portugal
Site PT35104
Santa Maria da Feira, Portugal
Site PT35107
Vila Real, Portugal
Romania
Site RO40002
Bucharest, Romania
Site RO40005
Cluj-Napoca, Romania
Site RO40007
Cluj-Napoca, Romania
Site RO40003
Craiova, Romania
Site RO40004
Floresti, Romania
Site RO40001
Iasi, Romania
Site RO40006
Iasi, Romania
Site RO40008
Timisoara, Romania
Site RO40010
Timisoara, Romania
Spain
Site ES34006
Barcelona, Spain
Site ES34009
Barcelona, Spain
Site ES34010
Barcelona, Spain
Site ES34005
Coruña, Spain
Site ES34001
Elche, Spain
Site ES34002
Madrid, Spain
Site ES34003
Madrid, Spain
Site ES34008
Madrid, Spain
Site ES34013
Madrid, Spain
Site ES34011
Malaga, Spain
Site ES34004
Pamplona, Spain
Site ES34007
Valencia, Spain
Site ES34012
Valencia, Spain
Taiwan
Site TW88602
Kaohsiung, Taiwan
Site TW88603
Taichung, Taiwan
Site TW88604
Taipei, Taiwan
Site TW88605
Tianan, Taiwan
Thailand
Site TH66002
Bangkok, Thailand
Site TH66005
Bangkok, Thailand
Site TH66007
Bangkok, Thailand
Site TH66009
Bangkok, Thailand
Site TH66011
Laksi, Thailand
Site TH66001
Muang, Thailand
Site TH66003
Muang, Thailand
Site TH66006
Pathumthani, Thailand
Site TH66010
Pathumwan, Thailand
Site TH66004
Songkla, Thailand
Site TH66008
Watthana, Thailand
Turkey
Site TR90008
Pendik, Istanbul, Turkey
Site TR90003
Atakum, Turkey
Site TR90004
Balcali, Turkey
Site TR90012
Bornova, Turkey
Site TR90001
Bursa, Turkey
Site TR90002
Istanbul, Turkey
Site TR90010
Istanbul, Turkey
Site TR90015
Istanbul, Turkey
Site TR90013
Konyaalti, Turkey
Site TR90007
Konya, Turkey
Site TR90011
Malatya, Turkey
United Kingdom
Site GB44004
Cardiff, Wales, United Kingdom
Site GB44002
Bristol, United Kingdom
Site GB44001
London, United Kingdom
Site GB44005
Northwood, United Kingdom
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
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Study Director: Medical Director Astellas Pharma Global Development
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Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT03653507    
Other Study ID Numbers: 8951-CL-0302
2018-000519-26 ( EudraCT Number )
CTR20190261 ( Registry Identifier: ChinaDrugTrials.org.cn )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
CLDN 18.2
gastroesophageal junction cancer
adenocarcinoma
IMAB362
oxaliplatin
HER2
claudiximab
capecitabine
gastric cancer
HER2 Negative
zolbetuximab
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents