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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03504397




Registration number
NCT03504397
Ethics application status
Date submitted
12/04/2018
Date registered
20/04/2018
Date last updated
26/06/2020

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2017-002567-17
Secondary ID [2] 0 0
8951-CL-0301
Universal Trial Number (UTN)
Trial acronym
Spotlight
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer 0 0
Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer 0 0
Metastatic Gastric Adenocarcinoma or Cancer 0 0
Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - zolbetuximab
Treatment: Drugs - placebo
Treatment: Drugs - oxaliplatin
Treatment: Drugs - folinic acid
Treatment: Drugs - fluorouracil

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.

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.


Treatment: Drugs: zolbetuximab
Zolbetuximab will be administered as a minimum 2-hour IV infusion.

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

Treatment: Drugs: oxaliplatin
Oxaliplatin will be administered as a 2-hour IV infusion

Treatment: Drugs: folinic acid
Folinic acid will be administered as a 2-hour IV infusion.

Treatment: Drugs: fluorouracil
Fluorouracil will be administered as IV bolus over 5-15 minutes and continuous IV infusion over 46-48 hours.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to 13 months
Secondary outcome [1] 0 0
Overall Survival (OS) - OS is defined as the time from the date of randomization until the date of death from any cause.
Timepoint [1] 0 0
Up to 23 months
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Up to 13 months
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Up to 13 months
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Up to 16 months
Secondary outcome [5] 0 0
Number of participants with laboratory assessments abnormalities and or adverse events - Number of participants with potentially clinically significant laboratory values.
Timepoint [5] 0 0
Up to 14 months
Secondary outcome [6] 0 0
Number of participants with vital signs abnormalities and or adverse events - Number of participants with potentially clinically significant vital sign values.
Timepoint [6] 0 0
Up to 14 months
Secondary outcome [7] 0 0
Number of participants with electrocardiograms (ECG) abnormalities and or adverse events - Number of participants with potentially clinically significant ECG values.
Timepoint [7] 0 0
Up to 14 months
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Up to 13 months
Secondary outcome [9] 0 0
Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30) questionnaire - The EORTC-QLQ-C30 is a cancer-specific instrument consisting of 5 functional domain scales: physical, role, emotional, social and cognitive.
Timepoint [9] 0 0
Up to 16 months
Secondary outcome [10] 0 0
HRQoL measured by the QLQ-OG25 questionnaire - The EORTC-QLQ-OG25 instrument evaluates Gastric and GEJ cancer-specific symptoms such as stomach discomfort, difficulties eating and swallowing and indigestion.
Timepoint [10] 0 0
Up to 16 months
Secondary outcome [11] 0 0
HRQoL measured by the Global Pain (GP) questionnaire - The GP instrument is a single assessment of overall pain.
Timepoint [11] 0 0
Up to 16 months
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
Up to 16 months
Secondary outcome [13] 0 0
PK of zolbetuximab: Concentration Immediately Prior to Dosing at multiple dosing (Ctrough) - Ctrough will be derived from the PK serum samples collected.
Timepoint [13] 0 0
Up to 16 months
Secondary outcome [14] 0 0
Number of anti-drug antibody (ADA) Positive Participants - Immunogenicity will be measured by the number of participants that are ADA positive.
Timepoint [14] 0 0
Up to 16 months

Eligibility
Key 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 6 months after the final study drug administration

- 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 agree not to donate ova starting at screening and throughout the
study period, and for 6 months after the final study drug administration.

- 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.

- 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 case of
multiple laboratory data within this period, the most recent data 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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject has received prior systemic chemotherapy for locally advanced unresectable or
metastatic gastric or GEJ adenocarcinoma. However, subject may have received either
neo-adjuvant or adjuvant chemotherapy as long as it was completed at least 6 months
prior to randomization. Subject 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Site AU61002 - Douglas
Recruitment hospital [2] 0 0
Site AU61011 - Tugun
Recruitment hospital [3] 0 0
Site AU61008 - Adelaide
Recruitment hospital [4] 0 0
Site AU61006 - East Bentleigh
Recruitment hospital [5] 0 0
Site AU61007 - Kogarah
Recruitment postcode(s) [1] 0 0
4814 - Douglas
Recruitment postcode(s) [2] 0 0
4224 - Tugun
Recruitment postcode(s) [3] 0 0
5011 - Adelaide
Recruitment postcode(s) [4] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [5] 0 0
2217 - Kogarah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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Connecticut
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Florida
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Kentucky
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Massachusetts
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New York
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Oklahoma
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Oregon
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Pennsylvania
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South Dakota
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Texas
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Virginia
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Washington
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Belgium
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Antwerpen
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Belgium
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Bruxelles-Capitale, Région De
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Belgium
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Hainaut
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Belgium
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Liege
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Belgium
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Oost-Vlaanderen
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Belgium
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Vlaams Brabant
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Belgium
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Brugge
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Belgium
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Brussels
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Brazil
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Distrito Federal
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Brazil
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Rio Grande Do Sul
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Brazil
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Santa Catarina
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Brazil
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Sao Paulo
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Brazil
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São Paulo
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Quebec
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Chile
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Santiago
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Chile
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Valdivia
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China
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Heilongjiang
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China
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Jiangsu
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China
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Zhejiang
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China
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Beijing
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China
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Zhengzhou
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Colombia
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Antioquia
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Colombia
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Córdoba
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Colombia
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Valle
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Cali
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Colombia
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Medellin
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Bretagne
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Paris
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France
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Rhone
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France
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Vienne
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France
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Nice Cedex 2
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Bavaria
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Bayern
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Rheinland-Pfalz
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Germany
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Sachsen-Anhalt
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Germany
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Sachsen
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Heilbronn
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Israel
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HaMerkaz
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Israel
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Holon
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Israel
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Jerusalem
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Israel
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Petah-Tikva
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Israel
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Tel Aviv
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Italy
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Forli
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Italy
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Lombardia
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Italy
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VI
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Italy
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Ancona
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Italy
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Bergamo
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Italy
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Cremona
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Italy
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Milano
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Italy
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Modena
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Italy
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Padova
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Italy
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Parma
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Italy
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Perugia
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Italy
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Piacenza
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Italy
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Pisa
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Italy
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Reggio Emilia
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Italy
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Roma
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Italy
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Turin TO
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Fukuoka
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Gyeonggido [Kyonggi-do]
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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Mexico
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Aguascalientes
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Mexico
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Oaxaca
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Peru
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Lima
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Peru
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Arequipa
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Poland
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Lubuskie
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Poland
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Mazowieckie
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Poland
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Podkarpackie
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Spain
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Barcelona
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Spain
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Castilla Y Leon
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Spain
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Madrid
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Spain
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Murcia
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Spain
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Sevilla
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Spain
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Zaragoza
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Taiwan
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Taoyuan
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
State/province [122] 0 0
Tainan
Country [123] 0 0
Taiwan
State/province [123] 0 0
Taipei
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United Kingdom
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Aberdeenshire
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United Kingdom
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London, City Of
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United Kingdom
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Scotland
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United Kingdom
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Surrey
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United Kingdom
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Coventry
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Astellas Pharma Global Development, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03504397
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Medical Lead
Address 0 0
Astellas Pharma Global Development, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Astellas Pharma Global Development
Address 0 0
Country 0 0
Phone 0 0
800-888-7704
Fax 0 0
Email 0 0
astellas.registration@astellas.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03504397