search
Back to results

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)

Primary Purpose

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
zolbetuximab
oxaliplatin
capecitabine
placebo
Sponsored by
Astellas Pharma Global Development, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer focused on measuring CLDN 18.2, gastroesophageal junction cancer, adenocarcinoma, IMAB362, oxaliplatin, HER2, claudiximab, capecitabine, gastric cancer, HER2 Negative, zolbetuximab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A female subject is eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin (βhCG) and a demonstrated non-pregnant status through additional testing are eligible) and at least 1 of the following conditions applies:

    • Not a woman of childbearing potential (WOCBP) OR
    • WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.
  • Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study treatment administration.
  • Female subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.
  • A male subject with female partner(s) of childbearing potential:

    • must agree to use contraception during the treatment period and for 6 months after the final study treatment administration.
  • A male subject must not donate sperm during the treatment period and for 6 months after the final study treatment administration.
  • Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study treatment administration.
  • Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.
  • Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization.
  • Subject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, ≤ 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.
  • Subject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central IHC testing.
  • Subject has a HER2-negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen.
  • Subject has ECOG performance status 0 or 1.
  • Subject has predicted life expectancy ≥ 12 weeks.
  • Subject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility.

    • Hemoglobin (Hb) ≥ 9 g/dl. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb ≥ 9 g/dL.
    • Absolute Neutrophil Count (ANC) ≥ 1.5x10^9/L
    • Platelets ≥ 100x10^9/L
    • Albumin ≥ 2.5 g/dL
    • Total Bilirubin ≤ 1.5 x upper limit of normal (ULN) without liver metastases (or < 3.0 x ULN if liver metastases are present)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (or ≤ 5 x ULN if liver metastases are present)
    • Estimated creatinine clearance ≥ 30 mL/min
    • Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy)

Exclusion Criteria:

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

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

    • Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident (CVA) or hypertensive crisis within 6 months prior to randomization.
    • History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes
    • QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects
    • History or family history of congenital long QT syndrome
    • Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for > 1 month prior to randomization are eligible).
  • Subject has a history of central nervous system (CNS) metastases and/or carcinomatous meningitis from gastric/GEJ cancer..
  • Subject has known peripheral sensory neuropathy > grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality.
  • Subject has had a major surgical procedure ≤ 28 days prior to randomization.

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

Sites / Locations

  • Pacific Cancer Care
  • University of Kansas Cancer Center and Medical Pavilion
  • Ochsner Clinic CCOP
  • New Mexico Oncology Hematology
  • Montefiore Medical Center (MMC)
  • Weill Cornell Medical College (WCMC)
  • Prisma Health Cancer Institute
  • Parkland Hospital
  • University of Texas Southwestern Medical Center
  • Houston Methodist Cancer Center and Institute of Academic Medicine - Oncology
  • Utah Cancer Specialist
  • Site AR54009
  • Site AR54006
  • Site AR54001
  • Site AR54004
  • Site AR54003
  • Site CA15003
  • Site CA15002
  • Site CA15004
  • Site CN86034
  • Site CN86037
  • Site CN86032
  • Site CN86012
  • Site CN86029
  • Site CN86043
  • Site CN86027
  • Site CN86046
  • Site CN86007
  • Site CN86044
  • Site CN86035
  • Site CN86050
  • Site CN86025
  • Site CN86002
  • Site CN86049
  • Site CN86053
  • Site CN86021
  • Site CN86039
  • Site CN86052
  • Site CN86054
  • Site CN86015
  • Site CN86001
  • Site CN86042
  • Site CN86051
  • Site CN86036
  • Site CN86038
  • Site CN86016
  • Site CN86045
  • Site CN86014
  • Site CN86026
  • Site CN86047
  • Site CN86017
  • Site CN86009
  • Site CN86040
  • Site CN86031
  • Site CN86004
  • Site CN86005
  • Site CN86013
  • Site CN86030
  • Site CN86011
  • Site CN86024
  • Site HR38501
  • Site HR38502
  • Site HR38503
  • Site GR30001
  • Site GR30004
  • Site GR30003
  • Site GR30005
  • Site GR30007
  • Site GR30002
  • Site GR30006
  • Site IE35301
  • Site IE35302
  • Site JP81007
  • Site JP81008
  • Site JP81004
  • Site JP81003
  • Site JP81001
  • Site JP81010
  • Site JP81005
  • Site JP81002
  • Site JP81006
  • Site JP81012
  • Site JP81009
  • Site JP81011
  • Site KR82002
  • Site KR82006
  • Site KR82007
  • Site KR82014
  • Site KR82008
  • Site KR82010
  • Site KR82011
  • Site KR82001
  • Site KR82003
  • Site KR82012
  • Site KR82013
  • Site KR82015
  • Site KR82009
  • Site MY60001
  • Site MY60004
  • Site MY60002
  • Site MY60003
  • Site MY60005
  • Site NL31004
  • Site NL31003
  • Site PT35109
  • Site PT35110
  • Site PT35111
  • Site PT35102
  • Site PT35106
  • Site PT35105
  • Site PT35108
  • Site PT35104
  • Site PT35101
  • Site PT35107
  • Site RO40002
  • Site RO40005
  • Site RO40007
  • Site RO40003
  • Site RO40004
  • Site RO40001
  • Site RO40006
  • Site RO40008
  • Site ES34006
  • Site ES34009
  • Site ES34010
  • Site ES34005
  • Site ES34001
  • Site ES34002
  • Site ES34003
  • Site ES34008
  • Site ES34013
  • Site ES34011
  • Site ES34004
  • Site ES34007
  • Site ES34012
  • Site TW88602
  • Site TW88603
  • Site TW88604
  • Site TW88605
  • Site TH66002
  • Site TH66005
  • Site TH66007
  • Site TH66009
  • Site TH66011
  • Site TH66001
  • Site TH66003
  • Site TH66006
  • Site TH66010
  • Site TH66004
  • Site TH66008
  • Site TR90008
  • Site TR90003
  • Site TR90004
  • Site TR90012
  • Site TR90001
  • Site TR90002
  • Site TR90010
  • Site TR90015
  • Site TR90013
  • Site TR90007
  • Site TR90011
  • Site GB44004
  • Site GB44002
  • Site GB44001
  • Site GB44005

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A (zolbetuximab plus CAPOX)

Arm B (placebo plus CAPOX)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
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

Overall Survival (OS)
OS is defined as the time from the date of randomization until the date of death from any cause.
Time to confirmed deterioration (TTCD) in participant-reported physical functioning and Global Health Status/Quality of Life (GHS/QoL)
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.
Objective Response Rate (ORR)
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.
Duration Of Response (DOR)
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.
Safety and tolerability assessed by adverse events (AEs)
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.
Number of participants with laboratory assessments abnormalities and or adverse events
Number of participants with potentially clinically significant laboratory values.
Number of participants with vital signs abnormalities and or adverse events
Number of participants with potentially clinically significant vital sign values.
Number of participants with electrocardiograms (ECG) abnormalities and or adverse events
Number of participants with potentially clinically significant ECG values.
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events
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.
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)
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.
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
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.
Health Related Quality of Life (HRQoL) measured by the Global Pain (GP) questionnaire
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.
Health Related Quality of Life (HRQoL) measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) questionnaire
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.
Pharmacokinetics (PK) of zolbetuximab: Concentration Immediately Prior to Dosing at multiple dosing (Ctrough)
Ctrough will be derived from the PK serum samples collected.
Number of anti-drug antibody (ADA) Positive Participants
Immunogenicity will be measured by the number of participants that are ADA positive.

Full Information

First Posted
August 24, 2018
Last Updated
October 23, 2023
Sponsor
Astellas Pharma Global Development, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03653507
Brief Title
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
Acronym
GLOW
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 28, 2018 (Actual)
Primary Completion Date
October 25, 2022 (Actual)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Global Development, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
Detailed Description
The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
CLDN 18.2, gastroesophageal junction cancer, adenocarcinoma, IMAB362, oxaliplatin, HER2, claudiximab, capecitabine, gastric cancer, HER2 Negative, zolbetuximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
507 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (zolbetuximab plus CAPOX)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B (placebo plus CAPOX)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
zolbetuximab
Other Intervention Name(s)
IMAB362
Intervention Description
Zolbetuximab will be administered as a minimum 2-hour IV infusion.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
Oxaliplatin will be administered as a 2-hour IV infusion.
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Description
Capecitabine will be administered orally twice daily (bid).
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo will be administered as a minimum 2-hour IV infusion.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
up to 13 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization until the date of death from any cause.
Time Frame
up to 23 months
Title
Time to confirmed deterioration (TTCD) in participant-reported physical functioning and Global Health Status/Quality of Life (GHS/QoL)
Description
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.
Time Frame
Up to 16 months
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
up to 13 months
Title
Duration Of Response (DOR)
Description
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.
Time Frame
up to 13 months
Title
Safety and tolerability assessed by adverse events (AEs)
Description
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.
Time Frame
up to 16 months
Title
Number of participants with laboratory assessments abnormalities and or adverse events
Description
Number of participants with potentially clinically significant laboratory values.
Time Frame
up to 14 months
Title
Number of participants with vital signs abnormalities and or adverse events
Description
Number of participants with potentially clinically significant vital sign values.
Time Frame
up to 14 months
Title
Number of participants with electrocardiograms (ECG) abnormalities and or adverse events
Description
Number of participants with potentially clinically significant ECG values.
Time Frame
up to 14 months
Title
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events
Description
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.
Time Frame
up to 13 months
Title
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)
Description
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.
Time Frame
up to 16 months
Title
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
Description
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.
Time Frame
up to 16 months
Title
Health Related Quality of Life (HRQoL) measured by the Global Pain (GP) questionnaire
Description
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.
Time Frame
up to 16 months
Title
Health Related Quality of Life (HRQoL) measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) questionnaire
Description
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.
Time Frame
up to 16 months
Title
Pharmacokinetics (PK) of zolbetuximab: Concentration Immediately Prior to Dosing at multiple dosing (Ctrough)
Description
Ctrough will be derived from the PK serum samples collected.
Time Frame
up to 16 months
Title
Number of anti-drug antibody (ADA) Positive Participants
Description
Immunogenicity will be measured by the number of participants that are ADA positive.
Time Frame
up to 16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A female subject is eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin (βhCG) and a demonstrated non-pregnant status through additional testing are eligible) and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs. Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study treatment administration. Female subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs. A male subject with female partner(s) of childbearing potential: must agree to use contraception during the treatment period and for 6 months after the final study treatment administration. A male subject must not donate sperm during the treatment period and for 6 months after the final study treatment administration. Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study treatment administration. Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma. Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization. Subject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, ≤ 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy. Subject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central IHC testing. Subject has a HER2-negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen. Subject has ECOG performance status 0 or 1. Subject has predicted life expectancy ≥ 12 weeks. Subject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility. Hemoglobin (Hb) ≥ 9 g/dl. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb ≥ 9 g/dL. Absolute Neutrophil Count (ANC) ≥ 1.5x10^9/L Platelets ≥ 100x10^9/L Albumin ≥ 2.5 g/dL Total Bilirubin ≤ 1.5 x upper limit of normal (ULN) without liver metastases (or < 3.0 x ULN if liver metastases are present) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (or ≤ 5 x ULN if liver metastases are present) Estimated creatinine clearance ≥ 30 mL/min Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy) Exclusion Criteria: Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as it was completed at least 6 months prior to randomization. Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma ≤ 14 days prior to randomization and has not recovered from any related toxicity. Subject has received treatment with herbal medications or other treatments that have known antitumor activity within 28 days prior to randomization. Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed. Subject has received other investigational agents or devices within 28 days prior to randomization. Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies. Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment. Subject has prior severe allergic reaction or intolerance to any component of CAPOX. Subject has known dihydropyrimidine dehydrogenase (DPD) deficiency. Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting. Subject has significant gastric bleeding and/or untreated gastric ulcers that exclude the subject from participation. Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen (HBs Ag)) or C infection. NOTE: Screening for these infections should be conducted per local requirements. For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab) positive, an HB deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded. Subjects with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test are eligible. Subjects treated for HCV with undetectable viral load results are eligible. Subject has an active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization. Subject has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization. Subject has significant cardiovascular disease, including any of the following: Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident (CVA) or hypertensive crisis within 6 months prior to randomization. History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects History or family history of congenital long QT syndrome Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for > 1 month prior to randomization are eligible). Subject has a history of central nervous system (CNS) metastases and/or carcinomatous meningitis from gastric/GEJ cancer.. Subject has known peripheral sensory neuropathy > grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality. Subject has had a major surgical procedure ≤ 28 days prior to randomization. Subject is without complete recovery from a major surgical procedure ≤ 14 days prior to randomization. Subject has psychiatric illness or social situations that would preclude study compliance. Subject has another malignancy for which treatment is required. Subject has any concurrent disease, infection, or co-morbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
Facility Name
Pacific Cancer Care
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
University of Kansas Cancer Center and Medical Pavilion
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Ochsner Clinic CCOP
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
New Mexico Oncology Hematology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Montefiore Medical Center (MMC)
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Weill Cornell Medical College (WCMC)
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Prisma Health Cancer Institute
City
Boiling Springs
State/Province
South Carolina
ZIP/Postal Code
29316
Country
United States
Facility Name
Parkland Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Houston Methodist Cancer Center and Institute of Academic Medicine - Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Utah Cancer Specialist
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Site AR54009
City
Buenos Aires
Country
Argentina
Facility Name
Site AR54006
City
Pergamino
Country
Argentina
Facility Name
Site AR54001
City
San Miguel De Tucuman
Country
Argentina
Facility Name
Site AR54004
City
San Miguel de Tucumán
Country
Argentina
Facility Name
Site AR54003
City
Viedma
Country
Argentina
Facility Name
Site CA15003
City
Chicoutimi
State/Province
Quebec
Country
Canada
Facility Name
Site CA15002
City
Rimouski
State/Province
Quebec
Country
Canada
Facility Name
Site CA15004
City
Calgary
Country
Canada
Facility Name
Site CN86034
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Site CN86037
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Site CN86032
City
Haikou
State/Province
Hainan
Country
China
Facility Name
Site CN86012
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Site CN86029
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Site CN86043
City
Hengyang
State/Province
Hunan
Country
China
Facility Name
Site CN86027
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Site CN86046
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
Site CN86007
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Site CN86044
City
Baoding
Country
China
Facility Name
Site CN86035
City
Beijing
Country
China
Facility Name
Site CN86050
City
Beijing
Country
China
Facility Name
Site CN86025
City
Bengbu
Country
China
Facility Name
Site CN86002
City
Changchun
Country
China
Facility Name
Site CN86049
City
Changchun
Country
China
Facility Name
Site CN86053
City
Changchun
Country
China
Facility Name
Site CN86021
City
Changzhou
Country
China
Facility Name
Site CN86039
City
Chengdu
Country
China
Facility Name
Site CN86052
City
Dalian
Country
China
Facility Name
Site CN86054
City
Dalian
Country
China
Facility Name
Site CN86015
City
Fuzhou
Country
China
Facility Name
Site CN86001
City
Guangzhou
Country
China
Facility Name
Site CN86042
City
Guangzhou
Country
China
Facility Name
Site CN86051
City
Haebrin
Country
China
Facility Name
Site CN86036
City
Hangzhou
Country
China
Facility Name
Site CN86038
City
Linyi
Country
China
Facility Name
Site CN86016
City
Nanjing
Country
China
Facility Name
Site CN86045
City
Nanning
Country
China
Facility Name
Site CN86014
City
Shanghai
Country
China
Facility Name
Site CN86026
City
Shantou
Country
China
Facility Name
Site CN86047
City
Shenyang
Country
China
Facility Name
Site CN86017
City
Shijiazhuang
Country
China
Facility Name
Site CN86009
City
Tianjin
Country
China
Facility Name
Site CN86040
City
Tianjin
Country
China
Facility Name
Site CN86031
City
Urumchi
Country
China
Facility Name
Site CN86004
City
Wuhan
Country
China
Facility Name
Site CN86005
City
Wuhan
Country
China
Facility Name
Site CN86013
City
Xi'an
Country
China
Facility Name
Site CN86030
City
Xiamen
Country
China
Facility Name
Site CN86011
City
Xuzhou
Country
China
Facility Name
Site CN86024
City
Zhengzhou
Country
China
Facility Name
Site HR38501
City
Varazdin
Country
Croatia
Facility Name
Site HR38502
City
Zagreb
Country
Croatia
Facility Name
Site HR38503
City
Zagreb
Country
Croatia
Facility Name
Site GR30001
City
Athens
Country
Greece
Facility Name
Site GR30004
City
Heraklion
Country
Greece
Facility Name
Site GR30003
City
Larissa
Country
Greece
Facility Name
Site GR30005
City
Neo Faliro, Piraeus
Country
Greece
Facility Name
Site GR30007
City
Rio Patras
Country
Greece
Facility Name
Site GR30002
City
Thessaloniki
Country
Greece
Facility Name
Site GR30006
City
Thessaloniki
Country
Greece
Facility Name
Site IE35301
City
Dublin
Country
Ireland
Facility Name
Site IE35302
City
Dublin
Country
Ireland
Facility Name
Site JP81007
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Site JP81008
City
Akashi
State/Province
Hyogo
Country
Japan
Facility Name
Site JP81004
City
Kita-gun
State/Province
Kagawa
Country
Japan
Facility Name
Site JP81003
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Facility Name
Site JP81001
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Site JP81010
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Site JP81005
City
Utsunomiya
State/Province
Tochigi
Country
Japan
Facility Name
Site JP81002
City
Chiba
Country
Japan
Facility Name
Site JP81006
City
Kashiwa
Country
Japan
Facility Name
Site JP81012
City
Koto-ku
Country
Japan
Facility Name
Site JP81009
City
Matsuyama
Country
Japan
Facility Name
Site JP81011
City
Tsukiji
Country
Japan
Facility Name
Site KR82002
City
Daegu
Country
Korea, Republic of
Facility Name
Site KR82006
City
Goyang-si
Country
Korea, Republic of
Facility Name
Site KR82007
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Site KR82014
City
Incheon
Country
Korea, Republic of
Facility Name
Site KR82008
City
Jeollanam-do
Country
Korea, Republic of
Facility Name
Site KR82010
City
Jeonju-si
Country
Korea, Republic of
Facility Name
Site KR82011
City
Seongnam-si
Country
Korea, Republic of
Facility Name
Site KR82001
City
Seoul
Country
Korea, Republic of
Facility Name
Site KR82003
City
Seoul
Country
Korea, Republic of
Facility Name
Site KR82012
City
Seoul
Country
Korea, Republic of
Facility Name
Site KR82013
City
Seoul
Country
Korea, Republic of
Facility Name
Site KR82015
City
Seoul
Country
Korea, Republic of
Facility Name
Site KR82009
City
Suwon
Country
Korea, Republic of
Facility Name
Site MY60001
City
Georgetown
Country
Malaysia
Facility Name
Site MY60004
City
Kota Kinabalu
Country
Malaysia
Facility Name
Site MY60002
City
Kuala Lumpur
Country
Malaysia
Facility Name
Site MY60003
City
Kuala Lumpur
Country
Malaysia
Facility Name
Site MY60005
City
Kuala Lumpur
Country
Malaysia
Facility Name
Site NL31004
City
Groningen
Country
Netherlands
Facility Name
Site NL31003
City
Tilburg
Country
Netherlands
Facility Name
Site PT35109
City
Braga
Country
Portugal
Facility Name
Site PT35110
City
Coimbra
Country
Portugal
Facility Name
Site PT35111
City
Guimaraes
Country
Portugal
Facility Name
Site PT35102
City
Lisboa
Country
Portugal
Facility Name
Site PT35106
City
Lisboa
Country
Portugal
Facility Name
Site PT35105
City
Porto
Country
Portugal
Facility Name
Site PT35108
City
Porto
Country
Portugal
Facility Name
Site PT35104
City
Santa Maria da Feira
Country
Portugal
Facility Name
Site PT35101
City
Setubal
Country
Portugal
Facility Name
Site PT35107
City
Vila Real
Country
Portugal
Facility Name
Site RO40002
City
Bucharest
Country
Romania
Facility Name
Site RO40005
City
Cluj-Napoca
Country
Romania
Facility Name
Site RO40007
City
Cluj-Napoca
Country
Romania
Facility Name
Site RO40003
City
Craiova
Country
Romania
Facility Name
Site RO40004
City
Floresti
Country
Romania
Facility Name
Site RO40001
City
Iasi
Country
Romania
Facility Name
Site RO40006
City
Iasi
Country
Romania
Facility Name
Site RO40008
City
Timisoara
Country
Romania
Facility Name
Site ES34006
City
Barcelona
Country
Spain
Facility Name
Site ES34009
City
Barcelona
Country
Spain
Facility Name
Site ES34010
City
Barcelona
Country
Spain
Facility Name
Site ES34005
City
Coruña
Country
Spain
Facility Name
Site ES34001
City
Elche
Country
Spain
Facility Name
Site ES34002
City
Madrid
Country
Spain
Facility Name
Site ES34003
City
Madrid
Country
Spain
Facility Name
Site ES34008
City
Madrid
Country
Spain
Facility Name
Site ES34013
City
Madrid
Country
Spain
Facility Name
Site ES34011
City
Malaga
Country
Spain
Facility Name
Site ES34004
City
Pamplona
Country
Spain
Facility Name
Site ES34007
City
Valencia
Country
Spain
Facility Name
Site ES34012
City
Valencia
Country
Spain
Facility Name
Site TW88602
City
Kaohsiung
Country
Taiwan
Facility Name
Site TW88603
City
Taichung
Country
Taiwan
Facility Name
Site TW88604
City
Taipei
Country
Taiwan
Facility Name
Site TW88605
City
Tianan
Country
Taiwan
Facility Name
Site TH66002
City
Bangkok
Country
Thailand
Facility Name
Site TH66005
City
Bangkok
Country
Thailand
Facility Name
Site TH66007
City
Bangkok
Country
Thailand
Facility Name
Site TH66009
City
Bangkok
Country
Thailand
Facility Name
Site TH66011
City
Laksi
Country
Thailand
Facility Name
Site TH66001
City
Muang
Country
Thailand
Facility Name
Site TH66003
City
Muang
Country
Thailand
Facility Name
Site TH66006
City
Pathumthani
Country
Thailand
Facility Name
Site TH66010
City
Pathumwan
Country
Thailand
Facility Name
Site TH66004
City
Songkla
Country
Thailand
Facility Name
Site TH66008
City
Watthana
Country
Thailand
Facility Name
Site TR90008
City
Pendik
State/Province
Istanbul
Country
Turkey
Facility Name
Site TR90003
City
Atakum
Country
Turkey
Facility Name
Site TR90004
City
Balcali
Country
Turkey
Facility Name
Site TR90012
City
Bornova
Country
Turkey
Facility Name
Site TR90001
City
Bursa
Country
Turkey
Facility Name
Site TR90002
City
Istanbul
Country
Turkey
Facility Name
Site TR90010
City
Istanbul
Country
Turkey
Facility Name
Site TR90015
City
Istanbul
Country
Turkey
Facility Name
Site TR90013
City
Konyaalti
Country
Turkey
Facility Name
Site TR90007
City
Konya
Country
Turkey
Facility Name
Site TR90011
City
Malatya
Country
Turkey
Facility Name
Site GB44004
City
Cardiff
State/Province
Wales
Country
United Kingdom
Facility Name
Site GB44002
City
Bristol
Country
United Kingdom
Facility Name
Site GB44001
City
London
Country
United Kingdom
Facility Name
Site GB44005
City
Northwood
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/

Learn more about this trial

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

We'll reach out to this number within 24 hrs