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)

• ClinicalTrials.gov Identifier: NCT03653507
• Recruitment Status: Active, not recruiting
• First Posted: August 31, 2018
• Last Update Posted: April 24, 2024
• Sponsor: Astellas Pharma Global Development, Inc.
• Information provided by (Responsible Party): Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Study Description

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

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed Description:

The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up. After the marketing approval in Japan on 26 Mar 2024, this study continued as "post marketing clinical study" in Japan. In the rest of the countries which participated in this study, this study continued as clinical study.

Study Design

• 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
• Actual Primary Completion Date: October 25, 2022
• Estimated Study Completion Date: April 30, 2025

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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. (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.

Contacts and Locations

Locations

United States, California

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 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 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 IE35301

Dublin, 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 KR82015

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 PT35101

Setubal, 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

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

• Study Director: Medical Director; Astellas Pharma Global Development

More Information

• 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
• Last Update Posted: April 24, 2024
• Last Verified: April 2024

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/

• 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:

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Capecitabine; Oxaliplatin; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents