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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653507
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : February 20, 2020
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, 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
Estimated Enrollment : 500 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 : September 26, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : April 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 8 treatments of CAPOX, 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 8 treatments of CAPOX, 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. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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

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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)
    • WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for 6 months after the final study treatment administration
  • 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 6 months after the final study treatment administration.
  • 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 case of multiple central laboratory data within this period, the most recent data 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 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


Contacts
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Contact: Astellas Pharma Global Development 800-888-7704 astellas.registration@astellas.com

Locations
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United States, California
University of Southern California Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Pacific Cancer Care Recruiting
Monterey, California, United States, 93940
United States, Kansas
University of Kansas Cancer Center and Medical Pavilion Recruiting
Fairway, Kansas, United States, 66205
United States, Louisiana
Ochsner Clinic CCOP Recruiting
New Orleans, Louisiana, United States, 70121
United States, New Mexico
New Mexico Oncology Hematology Recruiting
Albuquerque, New Mexico, United States, 87109
United States, New York
Weill Cornell Medical College (WCMC) Recruiting
New York, New York, United States, 10021
United States, Oklahoma
Mercy Clinic Oncology and Hematology Recruiting
Oklahoma City, Oklahoma, United States, 73120
United States, South Carolina
Greenville Health System Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
United States, Texas
Parkland Hospital Recruiting
Dallas, Texas, United States, 75390
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Houston Methodist Cancer Center and Institute of Academic Medicine - Oncology Recruiting
Houston, Texas, United States, 77030
United States, Utah
Utah Cancer Specialist Recruiting
Salt Lake City, Utah, United States, 84106
Argentina
Site AR54009 Recruiting
Buenos Aires, Argentina
Site AR54008 Recruiting
Córdoba, Argentina
Site AR54001 Recruiting
San Miguel De Tucuman, Argentina
Site AR54004 Recruiting
San Miguel de Tucumán, Argentina
Site AR54003 Recruiting
Viedma, Argentina
Austria
Site AT43004 Recruiting
Vienna, Austria
Canada, British Columbia
Site CA15001 Recruiting
Vancouver, British Columbia, Canada
Canada, Quebec
Site CA15003 Recruiting
Chicoutimi, Quebec, Canada
Site CA15002 Recruiting
Rimouski, Quebec, Canada
Canada
Site CA15004 Recruiting
Calgary, Canada
China
Site CN86044 Recruiting
Baoding, China
Site CN86018 Recruiting
Beijing, China
Site CN86025 Recruiting
Bengbu, China
Site CN86021 Recruiting
Changzhou, China
Site CN86039 Recruiting
Chengdu, China
Site CN86001 Recruiting
Guangzhou, China
Site CN86038 Recruiting
Linyi, China
Site CN86045 Recruiting
Nanning, China
Site CN86009 Recruiting
Tianjin, China
Site CN86040 Recruiting
Tianjin, China
Site CN86031 Recruiting
Urumchi, China
Site CN86004 Recruiting
Wuhan, China
Site CN86005 Recruiting
Wuhan, China
Site CN86013 Recruiting
Xi'an, China
Site CN86033 Recruiting
Xiangyang, China
Site CN86011 Recruiting
Xuzhou, China
Croatia
Site HR38504 Recruiting
Osijek, Croatia
Site HR38501 Recruiting
Varazdin, Croatia
Site HR38502 Recruiting
Zagreb, Croatia
Site HR38503 Recruiting
Zagreb, Croatia
Greece
Site GR30001 Recruiting
Athens, Greece
Site GR30004 Recruiting
Heraklion, Greece
Site GR30003 Recruiting
Larissa, Greece
Site GR30005 Recruiting
Neo Faliro, Piraeus, Greece
Site GR30007 Recruiting
Rio Patras, Greece
Site GR30002 Recruiting
Thessaloniki, Greece
Site GR30006 Recruiting
Thessaloniki, Greece
Ireland
Site IE35301 Recruiting
Dublin, Ireland
Site IE35302 Recruiting
Dublin, Ireland
Japan
Site JP81008 Recruiting
Akashi, Hyogo, Japan
Site JP81004 Recruiting
Kita-gun, Kagawa, Japan
Site JP81003 Recruiting
Kawasaki, Kanagawa, Japan
Site JP81001 Recruiting
Yokohama, Kanagawa, Japan
Site JP81005 Recruiting
Utsunomiya, Tochigi, Japan
Site JP81002 Recruiting
Chiba, Japan
Site JP81007 Recruiting
Fukuoka, Japan
Korea, Republic of
Site KR82002 Recruiting
Daegu, Korea, Republic of
Site KR82006 Recruiting
Goyang-si, Korea, Republic of
Site KR82007 Recruiting
Gyeonggi-do, Korea, Republic of
Site KR82008 Recruiting
Hwasungun, Korea, Republic of
Site KR82010 Recruiting
Jeonju-si, Korea, Republic of
Site KR82001 Recruiting
Seoul, Korea, Republic of
Site KR82003 Recruiting
Seoul, Korea, Republic of
Site KR82009 Recruiting
Suwon, Korea, Republic of
Malaysia
Site MY60001 Recruiting
Georgetown, Malaysia
Site MY60004 Recruiting
Kota Kinabalu, Malaysia
Site MY60002 Recruiting
Kuala Lumpur, Malaysia
Site MY60003 Recruiting
Kuala Lumpur, Malaysia
Site MY60005 Recruiting
Kuala Lumpur, Malaysia
Netherlands
Site NL31004 Recruiting
Groningen, Netherlands
Site NL31003 Recruiting
Tilburg, Netherlands
Portugal
Site PT35109 Recruiting
Braga, Portugal
Site PT35110 Recruiting
Coimbra, Portugal
Site PT35111 Recruiting
Guimaraes, Portugal
Site PT35102 Recruiting
Lisboa, Portugal
Site PT35106 Recruiting
Lisboa, Portugal
Site PT35105 Recruiting
Porto, Portugal
Site PT35108 Recruiting
Porto, Portugal
Site PT35104 Recruiting
Santa Maria da Feira, Portugal
Site PT35101 Recruiting
Setubal, Portugal
Site PT35107 Recruiting
Vila Real, Portugal
Romania
Site RO40002 Recruiting
Bucharest, Romania
Site RO40009 Recruiting
Bucharest, Romania
Site RO40005 Recruiting
Cluj-Napoca, Romania
Site RO40007 Recruiting
Cluj-Napoca, Romania
Site RO40004 Recruiting
Floresti, Romania
Site RO40006 Recruiting
Iasi, Romania
Site RO40008 Recruiting
Timisoara, Romania
Site RO40010 Recruiting
Timisoara, Romania
Spain
Site ES34006 Recruiting
Barcelona, Spain
Site ES34009 Recruiting
Barcelona, Spain
Site ES34010 Recruiting
Barcelona, Spain
Site ES34005 Recruiting
Coruña, Spain
Site ES34001 Recruiting
Elche, Spain
Site ES34002 Recruiting
Madrid, Spain
Site ES34003 Recruiting
Madrid, Spain
Site ES34008 Recruiting
Madrid, Spain
Site ES34013 Recruiting
Madrid, Spain
Site ES34011 Recruiting
Malaga, Spain
Site ES34004 Recruiting
Pamplona, Spain
Site ES34007 Recruiting
Valencia, Spain
Site ES34012 Recruiting
Valencia, Spain
Taiwan
Site TW88602 Recruiting
Kaohsiung, Taiwan
Site TW88603 Recruiting
Taichung, Taiwan
Site TW88604 Recruiting
Taipei, Taiwan
Site TW88605 Recruiting
Tianan, Taiwan
Thailand
Site TH66002 Recruiting
Bangkok, Thailand
Site TH66005 Recruiting
Bangkok, Thailand
Site TH66007 Recruiting
Bangkok, Thailand
Site TH66009 Recruiting
Bangkok, Thailand
Site TH66011 Recruiting
Laksi, Thailand
Site TH66001 Recruiting
Muang, Thailand
Site TH66003 Recruiting
Muang, Thailand
Site TH66006 Recruiting
Pathumthani, Thailand
Site TH66010 Recruiting
Pathumwan, Thailand
Site TH66004 Recruiting
Songkla, Thailand
Site TH66008 Recruiting
Watthana, Thailand
Turkey
Site TR90003 Recruiting
Atakum, Turkey
Site TR90004 Recruiting
Balcali, Turkey
Site TR90012 Recruiting
Bornova, Turkey
Site TR90001 Recruiting
Bursa, Turkey
Site TR90002 Recruiting
Istanbul, Turkey
Site TR90010 Recruiting
Istanbul, Turkey
Site TR90015 Recruiting
Istanbul, Turkey
Site TR90013 Recruiting
Konyaalti, Turkey
Site TR90007 Recruiting
Konya, Turkey
Site TR90011 Recruiting
Malatya, Turkey
United Kingdom
Site GB44004 Recruiting
Cardiff, Wales, United Kingdom
Site GB44002 Recruiting
Bristol, United Kingdom
Site GB44001 Recruiting
London, United Kingdom
Site GB44005 Recruiting
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 )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Studies conducted with product indications or formulations that remain in development are assessed after study completion to determine if Individual Participant Data can be shared. The plan to share Individual Participant Data is based on the status of product approval or termination of the compound, in addition to other study-specific criteria described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

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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. ):
gastroesophageal junction cancer
gastric cancer
CLDN 18.2
adenocarcinoma
IMAB362
oxaliplatin
HER2
claudiximab
capecitabine
HER2 Negative
zolbetuximab
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Capecitabine
Oxaliplatin
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs