A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer (Spotlight)

• ClinicalTrials.gov Identifier: NCT03504397
• Recruitment Status: Active, not recruiting
• First Posted: April 20, 2018
• Last Update Posted: April 30, 2024
• Sponsor: Astellas Pharma Global Development, Inc.
• Information provided by (Responsible Party): Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Study Description

Brief Summary:

A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Why is this study being done? SPOTLIGHT is a new clinical study for adult patients who have any of: - advanced unresectable gastric or GEJ cancer - metastatic gastric or GEJ cancer. These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells. For patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death. Patients will be assigned to one of two groups by chance and given either: - zolbetuximab with mFOLFOX6; or - a placebo with mFOLFOX6. A placebo is a treatment that looks like the experimental medicine, but contains no medicine. The goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.

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: placebo; Drug: oxaliplatin; Drug: folinic acid; Drug: fluorouracil	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: 566 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 mFOLFOX6 Compared With Placebo Plus mFOLFOX6 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: June 21, 2018
• Actual Primary Completion Date: September 9, 2022
• Estimated Study Completion Date: May 31, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm A (zolbetuximab plus mFOLFOX6); 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 up to 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 or more cycles (each cycle is approximately 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. After 12 mFOLFOX6 treatments, participants may continue to receive fluorouracil (5-FU) and folinic acid 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: folinic acid; Folinic acid will be administered as a 2-hour IV infusion.; Drug: fluorouracil; Fluorouracil will be administered as IV bolus over 5-15 minutes and continuous IV infusion over 46-48 hours.
Placebo Comparator: Arm B (Placebo plus mFOLFOX6); Participants will receive placebo starting at Cycle 1 Day 1 and every 3 weeks thereafter. Additionally, participants will receive up to 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 or more cycles (each cycle is approximately 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. After 12 mFOLFOX6 treatments, participants may continue to receive fluorouracil (5-FU) and folinic acid at the investigator's discretion until the subject meets study treatment discontinuation criteria.	Drug: placebo; Placebo will be administered as a minimum 2-hour IV infusion.; Drug: oxaliplatin; Oxaliplatin will be administered as a 2-hour IV infusion; Drug: folinic acid; Folinic acid will be administered as a 2-hour IV infusion.; Drug: fluorouracil; Fluorouracil will be administered as IV bolus over 5-15 minutes and continuous IV infusion over 46-48 hours.

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. 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 (EORTC-QLQ-C30) questionnaire [ Time Frame: Up to 16 months ]
   The EORTC-QLQ-C30 is a cancer-specific instrument consisting of 5 functional domain scales: physical, role, emotional, social and cognitive.
10. HRQoL measured by the QLQ-OG25 questionnaire [ Time Frame: Up to 16 months ]
    The EORTC-QLQ-OG25 instrument evaluates Gastric and GEJ cancer-specific symptoms such as stomach discomfort, difficulties eating and swallowing and indigestion.
11. HRQoL measured by the Global Pain (GP) questionnaire [ Time Frame: Up to 16 months ]
    The GP instrument is a single assessment of overall pain.
12. 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. Time to confirmed deterioration (TTCD) [ Time Frame: Up to 16 months ]
    Calculated using the physical function (PF), OG25-Pain and Global Health Status (GHS)/QoL scores as measured by EORTC QLQ-C30 and QLQ-OG25. TTCD is defined as time to first confirmed deterioration (time from randomization to first clinically meaningful deterioration that is confirmed at the next scheduled visit).
14. 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:

• Female subject eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin and a demonstrated non-pregnant status through additional testing are eligible) and at least one of the following conditions applies:

  • Not a woman of child-bearing potential (WOCBP) OR
  • WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs
• Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.
• Female subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.
• A sexually active male subject with a female partner(s) who is of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.
• Male subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration.
• Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.
• Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.
• Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization.
• Subject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, ≤ 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.
• Subject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing.
• Subject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen. (Unique to China: Subject has a known HER2-negative gastric or GEJ tumor.)
• Subject has ECOG performance status 0 to 1.
• Subject has predicted life expectancy ≥ 12 weeks.

• Subject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility.

  • Hemoglobin (Hgb) ≥ 9 g/dL. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb ≥ 9 g/dL.
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
  • Platelets ≥ 100 x 10^9/L
  • Albumin ≥ 2.5 g/dL
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) without liver metastases (or < 3.0 x ULN if liver metastases are present)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (or ≤ 5 x ULN if liver metastases are present)
  • Estimated creatinine clearance ≥ 30 mL/min
  • Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy)

Exclusion Criteria:

• Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies, as long as it was completed at least 6 months prior to randomization. Subject may have received treatment with herbal medications that have known antitumor activity > 28 days prior to randomization.
• Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma ≤ 14 days prior to randomization and has not recovered from any related toxicity.
• Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed.
• Subject has received other investigational agents or devices within 28 days prior to randomization.
• Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies.
• Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment.
• Subject has prior severe allergic reaction or intolerance to any component of mFOLFOX6.
• Subject has known dihydropyrimidine dehydrogenase deficiency.
• Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.
• Subject has significant gastric bleeding and/or untreated gastric ulcers that would exclude the subject from participation.

• Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen (HBs Ag)) or C infection. NOTE: Screening for these infections should be conducted per local requirements.

  • For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab) positive, an HB deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded.
  • Subjects with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test are eligible.
  • Subjects treated for HCV with undetectable viral load results are eligible.
• Subject has an active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization.
• Subject has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.

• Subject has significant cardiovascular disease, including any of the following:

  • Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident (CVA) or hypertensive crisis within 6 months prior to randomization.
  • History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes)
  • QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects
  • History or family history of congenital long QT syndrome
  • Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for > 1 month prior to randomization are eligible).
• Subject has a history of central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ cancer.
• Subject has known peripheral sensory neuropathy > Grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality.

• Subject has had a major surgical procedure ≤ 28 days prior to randomization.

  • Subject is without complete recovery from a major surgical procedure ≤ 14 days prior to randomization.
• Subject has psychiatric illness or social situations that would preclude study compliance.
• Subject has another malignancy for which treatment is required.
• Subject has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.

Contacts and Locations

Locations

United States, Arizona

University of Arizona

Phoenix, Arizona, United States, 85004

The University of Arizona Medical Center

Tucson, Arizona, United States, 85724

United States, California

CBCC Global Research, Inc. at Comprehensive Blood and Cancer

Bakersfield, California, United States, 93309

City of Hope Nat'l Medical Center

Duarte, California, United States, 91010

St. Jude Hospital Yorba Linda

Fullerton, California, United States, 92835

Pacific Shores Medical Group

Huntington Beach, California, United States, 92648

Loma Linda University

Loma Linda, California, United States, 92354

The Angeles Clinic and Research Institute

Los Angeles, California, United States, 90025

University of California Davis

Sacramento, California, United States, 95817

University of California - San Francisco

San Francisco, California, United States, 94143

United States, Colorado

University of Colorado

Aurora, Colorado, United States, 80045

United States, Connecticut

Memorial Sloan Kettering Cancer Center

Middletown, Connecticut, United States, 07748-3052

United States, Florida

Memorial Cancer Institute - West

Hollywood, Florida, United States, 33021

University of Miami

Miami, Florida, United States, 33136

Orlando Health Inc

Orlando, Florida, United States, 32806

Memorial Hospital West

Pembroke Pines, Florida, United States, 33028

United States, Georgia

Cancer Treatment Centers of America, Atlanta

Newnan, Georgia, United States, 30265

United States, Illinois

Northwestern University Medical Center

Chicago, Illinois, United States, 60611

University of Chicago

Chicago, Illinois, United States, 60637

United States, Kentucky

Norton Cancer Institute

Louisville, Kentucky, United States, 40217

United States, Maryland

University of Maryland Medical Center(UMMC)Transplant Center

Baltimore, Maryland, United States, 21201

Maryland Oncology Hematology

Brandywine, Maryland, United States, 20613

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114-2696

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

United States, Michigan

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

United States, Minnesota

Health Partners Institute

Saint Louis Park, Minnesota, United States, 55426

Regions Hospital

Saint Paul, Minnesota, United States, 55101

United States, New Jersey

Memorial Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States, 07920

Memorial Sloan Kettering Cancer Center

Montvale, New Jersey, United States, 07645

United States, New York

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Memorial Sloan Kettering Cancer Center

Commack, New York, United States, 11725

Memorial Sloan Kettering Cancer Center

Harrison, New York, United States, 10604

Mount Sinai School of Medicine

New York, New York, United States, 10029-6574

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Stony Brook University Medical Center

Stony Brook, New York, United States, 11794-9452

Memorial Sloan Kettering Cancer Center

Uniondale, New York, United States, 11553

United States, Ohio

The Ohio State University Medical Center

Columbus, Ohio, United States, 43210

Precision Cancer Research -Dayton Physicians Network

Middletown, Ohio, United States, 45042

United States, Oklahoma

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, United States, 73104

United States, Oregon

Earle A. Chiles Research Institute

Portland, Oregon, United States, 97213

Oregon Health & Science University

Portland, Oregon, United States, 97239

United States, Pennsylvania

Lancaster General Hospital

Lancaster, Pennsylvania, United States, 17604

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Cancer Treatment Centers of America, Philadelphia

Philadelphia, Pennsylvania, United States, 19124

United States, Rhode Island

Rhode Island Hospital-Lifespan Cancer Institute

Providence, Rhode Island, United States, 02903

United States, South Dakota

Sanford Cancer Center

Sioux Falls, South Dakota, United States, 57104

United States, Texas

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

United States, Virginia

Inova Dwight and Martha Schar Cancer Institute

Fairfax, Virginia, United States, 22031

United States, Washington

MultiCare Regional Cancer Center - Gig Harbor

Auburn, Washington, United States, 98801

Seattle Cancer Care Alliance

Seattle, Washington, United States, 98109

Australia, Queensland

Site AU61002

Douglas, Queensland, Australia, 4814

Site AU61011

Tugun, Queensland, Australia, 4224

Australia, South Australia

Site AU61008

Adelaide, South Australia, Australia, 5011

Australia, Victoria

Site AU61006

East Bentleigh, Victoria, Australia, 3165

Australia

Site AU61007

Kogarah, Australia, 2217

Belgium

Site BE32007

Edegem, Antwerpen, Belgium, 2650

Site BE32001

Bruxelles, Bruxelles-Capitale, Région De, Belgium, 1200

Site BE32008

Mons, Hainaut, Belgium, 7000

Site BE32002

Bruxelles, Liege, Belgium, 1050

Site BE32012

Gent, Oost-Vlaanderen, Belgium, 9000

Site BE32006

Leuven, Vlaams Brabant, Belgium, 3000

Site BE32005

Brugge, Belgium, 8310

Site BE32004

Brussels, Belgium, 1000

Site BE32011

Charleroi, Belgium, 6000

Site BE32010

Haine-Saint-Paul, Belgium, 7100

Brazil

Site BR55010

Brasília, Distrito Federal, Brazil, 70200-730

Site BR55006

Lajeado, Rio Grande Do Sul, Brazil, 95900000

Site BR55002

Itajai, Santa Catarina, Brazil, 88301-220

Site BR55003

Santo Andre, Sao Paulo, Brazil, 09060-650

Site BR55005

Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000

Site BR55007

Barretos, São Paulo, Brazil, 14784-400

Site BR55017

Belo Horizonte, Brazil, 30130-090

Site BR55016

Passo Fundo, Brazil, 99010-260

Site BR55015

Rio de Janeiro, Brazil, 22793-080

Site BR55018

Santa Catarina, Brazil, 88501-003

Site BR55009

São Paulo, Brazil, 01509-900

Site BR55004

São Paulo, Brazil, 08270-070

Canada, Alberta

Site CA15005

Edmonton, Alberta, Canada, T6G 1Z2

Canada, New Brunswick

Site CA15009

Saint-John, New Brunswick, Canada, E2L 4L4

Canada, Ontario

Site CA15011

Toronto, Ontario, Canada, M5G 1X5

Canada, Quebec

Site CA15002

Montreal, Quebec, Canada, H3T 1M5

Site CA15008

Montreal, Quebec, Canada, H4A 3J1

Chile

Site CL56003

Providencia, Santiago, Chile, 7500921

Site CL56008

Providencia, Chile, 7520378

Site CL56005

Santiago, Chile, 8330032

Site CL56007

Valdivia, Chile, 5090000

China, Heilongjiang

Site CN86003

Haerbin, Heilongjiang, China, 150081

China, Jiangsu

Site CN86006

Nanjing, Jiangsu, China, 210008

China, Zhejiang

Site CN86004

Hangzhou Shi, Zhejiang, China, 310003

China

Site CN86009

Beijing, China, 100030

Site CN86002

Beijing, China, 100071

Site CN86005

Hefei, China, 230022

Site CN86001

Xiamen, China

Site CN86008

Zhengzhou, China, 450000

Colombia

Site CO57006

Medellín, Antioquia, Colombia, 574

Site CO57007

Monteria, Córdoba, Colombia, 230002

Site CO57009

Bogota, DC, Colombia, 110231

Site CO57005

Cali, Valle, Colombia

Site CO57001

Cali, Colombia

Site CO57002

Medellin, Colombia, 0574

France

Site FR33009

Dijon, Bourgogne, France, 21079

Site FR33010

Brest Cedex, Bretagne, France, 29609

Site FR33001

Rennes, Bretagne, France, 35042

Site FR33008

Besancon cedex, Franche-Comte, France, 25033

Site FR33011

Montpellier Cedex 5, Languedoc-Roussillon, France, 34298

Site FR33002

Paris cedex, Paris, France, 75970

Site FR33101

St Herblain, Pays-de-la-Loire, France, 44805

Site FR33005

Nice, Provence-Alpes-Côte-d'Azur, France, 06200

Site FR33003

Lyon, Rhone, France, 69008

Site FR33006

Poitiers, Vienne, France, 86021

Site FR33103

Creteil, France, 94000

Site FR33007

Nice Cedex 2, France, 06189

Site FR33104

Saint Priest en Jarez, France, 42270

Germany

Site DE49008

Munich, Bavaria, Germany, 81377

Site DE49007

Munchen, Bayern, Germany, 81925

Site DE49002

Mainz, Rheinland-Pfalz, Germany, 55101

Site DE49021

Halle, Sachsen-Anhalt, Germany, 06108

Site DE49015

Magdeburg, Sachsen-Anhalt, Germany, 39104

Site DE49010

Dresden, Sachsen, Germany, 01307

Site DE49004

Leipzig, Sachsen, Germany, 04103

Site DE49012

Berlin, Germany, 13125

Site DE49011

Berlin, Germany, 13353

Site DE49018

Dresden, Germany, 1067

Site DE49019

Heilbronn, Germany, 74078

Israel

Site IL97206

Kfar Saba, HaMerkaz, Israel, 44281

Site IL97210

HaDarom, Israel, 7030000

Site IL97201

Haifa, Israel, 3109601

Site IL97209

Holon, Israel, 58100

Site IL97202

Jerusalem, Israel, 91031

Site IL97203

Tel Aviv, Israel, 64239

Italy

Site IT39011

Meldola, Forli, Italy, 47014

Site IT39020

Monza, Lombardia, Italy, 20052

Site IT39023

Vicenza, VI, Italy, 36100

Site IT39013

Ancona, Italy, 60126

Site IT39004

Bergamo, Italy, 24127

Site IT39009

Cremona, Italy, 26100

Site IT39006

Milano, Italy, 20132

Site IT39008

Milano, Italy, 20141

Site IT39021

Modena, Italy, 41124

Site IT39016

Padova, Italy, 35128

Site IT39012

Parma, Italy, 43126

Site IT39018

Perugia, Italy, 05100

Site IT39003

Piacenza, Italy, 29100

Site IT39019

Pisa, Italy, 56126

Site IT39022

Reggio Emilia, Italy, 42123

Site IT39015

Roma, Italy, 00128

Site IT39026

Terni, Italy, 5100

Site IT39024

Turin TO, Italy, 5-10126

Japan

Site JP81009

Nagoya, Aichi, Japan

Site JP81003

Kashiwa, Chiba, Japan

Site JP81002

Matsuyama, Ehime, Japan

Site JP81007

Sapporo, Hokkaido, Japan

Site JP81014

Kobe, Hyogo, Japan

Site JP81001

Suita, Osaka, Japan

Site JP81015

Hidaka, Saitama, Japan

Site JP81010

Kitaadachi-gun, Saitama, Japan

Site JP81012

Sunto-gun, Shizuoka, Japan

Site JP81013

Bunkyo-ku, Tokyo, Japan

Site JP81006

Chuo-ku, Tokyo, Japan

Site JP81008

Koto-ku, Tokyo, Japan

Site JP81005

Fukuoka, Japan

Site JP81004

Osaka, Japan

Site JP81011

Osaka, Japan

Korea, Republic of

Site KR82002

Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620

Site KR82009

Suwon-si, Gyeonggido [Kyonggi-do], Korea, Republic of, 16247

Site KR82004

Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351

Site KR82008

Incheon, Korea, Republic of, 21556

Site KR82003

Seoul, Korea, Republic of, 03080

Site KR82005

Seoul, Korea, Republic of, 05505

Site KR82007

Seoul, Korea, Republic of, 152-703

Site KR82006

Seoul, Korea, Republic of, 6591

Mexico

Site MX52007

Ciudad de México, Distrito Federal, Mexico, 3100

Site MX52002

Mexico, Distrito Federal, Mexico, 06760

Site MX52010

Veracruz, Ver, Veracruz, Mexico, 91900

Site MX52001

Aguascalientes, Mexico, 20230

Site MX52003

Distrito Federal, Mexico, 06720

Site MX52009

Jalisco, Mexico, 45030

Site MX52004

Oaxaca, Mexico

Site MX52008

San Luis De Potosi, Mexico, 78250

Peru

Site PE51004

San Isidro, Lima, Peru, L27

Site PE51003

Arequipa, Peru, 4001

Site PE51005

Lima, Peru, 15036

Site PE51006

Lima, Peru, 15072

Site PE51001

Lima, Peru, L27

Poland

Site PL48004

Lublin, Lubuskie, Poland, 20-090

Site PL48007

Ostroleka, Mazowieckie, Poland, 07-410

Site PL48005

Wieliszew, Mazowieckie, Poland, 05-135

Site PL48002

Brzozow, Podkarpackie, Poland, 36-20

Site PL48009

Warszawa, Poland, 02-781

Spain

Site ES34013

Badalona, Barcelona, Spain, 08028

Site ES34010

Avila, Castilla Y Leon, Spain, 05004

Site ES34011

Alcorcon, Madrid, Spain, 28925

Site ES34005

Barcelona, Spain, 08003

Site ES34016

Barcelona, Spain, 08025

Site ES34015

Barcelona, Spain, 08035

Site ES34019

Burgos, Spain, 09006

Site ES34008

Madrid, Spain, 28007

Site ES34017

Madrid, Spain, 28033

Site ES34004

Madrid, Spain, 28034

Site ES34003

Murcia, Spain, 30120

Site ES34018

Sevilla, Spain, 41009

Site ES34006

Zaragoza, Spain, 50009

Taiwan

Site TW88605

Kwei-Shan, Taoyuan, Taiwan, 333

Site TW88608

Kaohsiung, Taiwan, 80756

Site TW88604

Kaohsiung, Taiwan, 833

Site TW88603

Taichung, Taiwan, 404

Site TW88607

Tainan, Taiwan, 704

Site TW88606

Taipei, Taiwan, 10002

Site TW88601

Taipei, Taiwan, 112

United Kingdom

Site GB44003

Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN

Site GB44101

London, London, City Of, United Kingdom, SW3 6JJ

Site GB44102

Sutton, Surrey, United Kingdom, SM2 5PT

Site GB44103

Cambridge, United Kingdom, CB2 0QQ

Site GB44009

Coventry, United Kingdom, CV2 2DX

Site GB44104

Dundee, United Kingdom, DD2 4BF

Site GB44008

Leeds, United Kingdom, LS7 9TF

Site GB44002

London, United Kingdom, NW1 2PG

Site GB44004

London, United Kingdom, W1G 6AD

Site GB44001

Manchester, United Kingdom, M20 4BX

Sponsors and Collaborators

Astellas Pharma Global Development, Inc.

Investigators

• Study Director: Global Medical Lead; Astellas Pharma Global Development, Inc.

More Information

• Responsible Party: Astellas Pharma Global Development, Inc.
• ClinicalTrials.gov Identifier: NCT03504397
• Other Study ID Numbers: 8951-CL-0301; 2017-002567-17 ( EudraCT Number ); CTR20190258 ( Registry Identifier: ChinaDrugTrials.org.cn )
• First Posted: April 20, 2018
• Last Update Posted: April 30, 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. ):

HER2; IMAB362; leucovorin; fluorouracil; Gastric cancer; claudiximab; zolbetuximab; oxaliplatin; adenocarcinoma; Gastro-Esophageal Junction cancer; HER2 Negative mFOLFOX6

Additional relevant MeSH terms:

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Leucovorin; Folic Acid; Oxaliplatin; Fluorouracil; Levoleucovorin; Antineoplastic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antidotes; Protective Agents; Vitamin B Complex; Vitamins; Micronutrients; Hematinics