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Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer (FAST)

Primary Purpose

CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction, CLDN18.2-positive Adenocarcinoma of Esophagus, CLDN18.2-positive Gastric Adenocarcinoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
epirubicin
oxaliplatin
capecitabine
zolbetuximab
Sponsored by
Astellas Pharma Global Development, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction focused on measuring IMAB362, ASP8951, zolbetuximab

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction
  • Inoperable locally advanced disease or resections with R2 outcome or recurrent or metastatic disease.
  • CLDN18.2 expression confirmed by immunohistochemistry in paraffin embedded tumor tissue sample.
  • Measurable and/or non-measurable disease as defined according to RECISTv1.1
  • Age ≥ 18 years
  • Written Informed Consent Form
  • ECOG performance status (PS) 0-1
  • Life expectancy > 3 months
  • HER2/neu negative patients and patients with HER2/neu positive status but not eligible to trastuzumab therapy in discretion of the investigator.
  • Adequate cardiac, hepatic, renal, hematologic function.

Exclusion Criteria:

  • Prior severe allergic reaction or intolerance to a monoclonal antibody, to the chemotherapeutics used in this study or any excipient in the respective formulations.
  • Previous chemotherapy for advanced disease.
  • Previous perioperative chemotherapy with curative intention within 6 months of start of study treatment. If interval is longer than 6 months (counted from the stop date of the perioperative chemotherapy), patients are allowed.
  • Known HIV infection or known symptomatic hepatitis (A, B, C).
  • Symptomatic cerebral metastases.
  • Pregnancy or breastfeeding.
  • Previous treatments with maximum cumulative doses of epirubicin > 500 mg/m² and/or other anthracyclines and anthracenediones.
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency.

Sites / Locations

  • Site BUL004
  • Site BUL001
  • Site BUL003
  • Site BUL005
  • Site BUL002
  • Site CZE002
  • Site CZE001
  • Site GER012
  • Site GER029-01
  • Site GER029
  • Site GER010
  • Site GER001
  • Site GER017
  • Site GER005
  • Site GER020
  • Site GER016
  • Site GER013
  • Site LAT001
  • Site LAT002
  • Site RUS011
  • Site RUS016
  • Site RUS006
  • Site RUS007
  • Site RUS009
  • Site RUS001
  • Site RUS017
  • Site RUS002
  • Site RUS023
  • Site RUS012
  • Site RUS014
  • Site RUS005
  • Site RUS019
  • Site RUS003
  • Site RUS010
  • Site RUS015
  • Site RUS013
  • Site UKR003
  • Site UKR001
  • Site UKR002
  • Site UKR008
  • Site UKR005
  • Site UKR007
  • Site UKR006
  • Site UKR015
  • Site UKR004
  • Site UKR011
  • Site UKR010
  • Site UKR009

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

EOX Treatment

EOX+zolbetuximab 800/600 mg/m^2

EOX+zolbetuximab 1000 mg/m^2

Arm Description

Participants will receive up to 8 cycles of epirubicin, oxaliplatin and capecitabine (EOX) chemotherapy treatment alone (50 mg/m^2 epirubicin intravenously on day 1 of each cycle, 130 mg/m^2 oxaliplatin intravenously on day 1 of each cycle, 625 mg/m^2 capecitabine orally twice daily on days 1 to 21 of each cycle). The first dose of capecitabine to be taken in the evening of day 1.

Participants will received up to 8 cycles of EOX chemotherapy treatment in combination with zolbetuximab administered as loading dose of 800 mg/m^2 intravenously on day 1 of cycle 1 followed by 600 mg/m^2 intravenously on day 1 of each subsequent cycle. Zolbetuximab to be administered prior to EOX chemotherapy. After completion of the EOX treatment phase, participants will be permitted to continue zolbetuximab monotherapy (600 mg/m^2 every 3 weeks to be administered intravenously as a 2-hour infusion) until progressive disease (PD), withdrawal of consent or unacceptable toxicity. PD per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study, an absolute increase of at least 5mm must also be demonstrated, unequivocal progression of existing non-target lesions and appearance of one or more new lesions is considered progression.

Participants will receive up to 8 cycles of EOX chemotherapy treatment in combination with zolbetuximab 1000 mg/m^2 intravenously on day 1 of each cycle. Zolbetuximab to be administered prior to EOX chemotherapy. After completion of the EOX treatment phase, participants will be permitted to continue zolbetuximab monotherapy (1000 mg/m^2 every 3 weeks administered intravenously as a 2-hour infusion ) until PD, withdrawal of consent or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
PFS is defined as the time from randomization to the first observation of disease progression (based on central reading) or death from any cause (as assessed by the independent reviewer). Participants without documented progression or death will be censored as of the last tumor evaluation determining lack of progression.
Number of Participants with Adverse Events (AEs)
An AE is defined as any unintended or undesirable, noxious or pathological change, compared to pre-existing conditions, experienced by a participant during a clinical study or the follow-up period, regardless of relationship to study medication. Treatment-emergent adverse event (TEAE) are those AEs that started or worsened after the first dose of study medication.

Secondary Outcome Measures

Clinical PFS
Clinical PFS (CPFS) is defined as the time from randomization to the first observation of disease progression, either confirmed by computed tomography (CT) scans or by clinical evaluation, or death from any cause (as assessed by the independent reviewer with clinical PD considered as an event). Participants without documented progression or death will be censored as of the last tumor evaluation determining lack of progression.
Overall Survival Rate at 12 Months
Overall survival rate at 12 months after therapy initiation is defined as a proportion of participants alive after 12 months from first dose of any study drug.
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause or last contact (if alive).
Time to Progression (TTP)
TTP is defined as the time from randomization to the first observation of disease progression (based on central reading as assessed by the investigator reviewer). Participants without documented progression will be censored as of the last tumor evaluation determining lack of progression.
Objective Tumor Response Rate (ORR)
ORR is defined as the fraction of participants with a complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (as assessed by the investigator reviewer). CR according to RECIST v1.1 is defined as the disappearance of all target lesions, any pathological lymph node must have reduction in short axis to < 10 mm, disappearance of all non-target lesions and normalization of tumor marker level should occur as well as no simultaneous appearance of new lesions. PR according to RECIST v1.1 is defined as at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter and no simultaneous increase in the size of any lesion or the appearance of new lesions.
Disease Control Rate (DCR)
DCR is defined as the fraction of participants with CR or PR or stable disease (SD) according to RECIST v1.1 (as assessed by the investigator reviewer). SD according to RECIST v1.1 is defined as neither sufficient shrinkage to qualify for PR or CR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter recorded since treatment started, measurements must meet the SD criteria at least once after study entry at a minimum interval not less than 6 weeks, no simultaneous increase in the size of any lesion or the appearance of new lesions should occur, evaluable lesions must remain stable or regress for this category.
Duration of Response (DOR)
DOR will be determined as the time when criteria for CR or PR are first met until the first date that recurrent or progressive disease or death occurs (as assessed by the independent reviewer).

Full Information

First Posted
June 19, 2012
Last Updated
January 14, 2020
Sponsor
Astellas Pharma Global Development, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01630083
Brief Title
Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer
Acronym
FAST
Official Title
A Randomized Phase II Multicenter, Open-Label Study Evaluating the Efficacy and Safety of IMAB362 in Combination With the EOX (Epirubicin, Oxaliplatin, Capecitabine) Regimen as First-Line Treatment of Patients With CLDN18.2-Positive Advanced Adenocarcinomas of the Stomach, the Esophagus or the Gastroesophageal Junction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 19, 2012 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)

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

5. Study Description

Brief Summary
The purpose of the trial is to assess the therapeutic effects and the safety profile of IMAB362 combined with EOX (epirubicin, oxaliplatin, capecitabine) as first-line treatment for patients with advanced adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction compared to EOX alone. Furthermore, sufficient binding of IMAB362 to the target cells is necessary for antitumoral activity. Thus, two dose levels ensuring a serum level above the in vitro predicted clinical efficacy threshold will be investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction, CLDN18.2-positive Adenocarcinoma of Esophagus, CLDN18.2-positive Gastric Adenocarcinoma
Keywords
IMAB362, ASP8951, zolbetuximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EOX Treatment
Arm Type
Active Comparator
Arm Description
Participants will receive up to 8 cycles of epirubicin, oxaliplatin and capecitabine (EOX) chemotherapy treatment alone (50 mg/m^2 epirubicin intravenously on day 1 of each cycle, 130 mg/m^2 oxaliplatin intravenously on day 1 of each cycle, 625 mg/m^2 capecitabine orally twice daily on days 1 to 21 of each cycle). The first dose of capecitabine to be taken in the evening of day 1.
Arm Title
EOX+zolbetuximab 800/600 mg/m^2
Arm Type
Experimental
Arm Description
Participants will received up to 8 cycles of EOX chemotherapy treatment in combination with zolbetuximab administered as loading dose of 800 mg/m^2 intravenously on day 1 of cycle 1 followed by 600 mg/m^2 intravenously on day 1 of each subsequent cycle. Zolbetuximab to be administered prior to EOX chemotherapy. After completion of the EOX treatment phase, participants will be permitted to continue zolbetuximab monotherapy (600 mg/m^2 every 3 weeks to be administered intravenously as a 2-hour infusion) until progressive disease (PD), withdrawal of consent or unacceptable toxicity. PD per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study, an absolute increase of at least 5mm must also be demonstrated, unequivocal progression of existing non-target lesions and appearance of one or more new lesions is considered progression.
Arm Title
EOX+zolbetuximab 1000 mg/m^2
Arm Type
Experimental
Arm Description
Participants will receive up to 8 cycles of EOX chemotherapy treatment in combination with zolbetuximab 1000 mg/m^2 intravenously on day 1 of each cycle. Zolbetuximab to be administered prior to EOX chemotherapy. After completion of the EOX treatment phase, participants will be permitted to continue zolbetuximab monotherapy (1000 mg/m^2 every 3 weeks administered intravenously as a 2-hour infusion ) until PD, withdrawal of consent or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
epirubicin
Intervention Description
Epirubicin will be administered at a dose of 50 mg/m^2 as a 15-minute intravenous infusion on day 1 of each cycle.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
Oxaliplatin will be administered at a dose of 130 mg/m^2 as a 2-hour intravenous infusion on day 1 of each cycle.
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Description
The daily dose of capecitabine will be 1250 mg/m^2. Capecitabine tablets to be given once daily at a dose of 625 mg/m^2 orally in the evening of day 1 of each cycle and twice daily at a dose of 625 mg/m^2 orally on days 2 to 21 of each cycle; the morning dose of capecitabine on day 1 of each cycle to be omitted due to administration of zolbetuximab, epirubicin and oxaliplatin.
Intervention Type
Drug
Intervention Name(s)
zolbetuximab
Other Intervention Name(s)
IMAB362
Intervention Description
Two different formats of zolbetuximab, comprising different strengths, to be provided. Vials contained 22 mg or 105 mg of zolbetuximab. Prior to administration, zolbetuximab will be reconstituted with 1.1 mL (22 mg zolbetuximab vials) or 5.0 mL (105 mg zolbetuximab vials) water for injection, which will result in a concentration of 20 mg/mL zolbetuximab. The extractable volume per vial will be 1 mL (for 22 mg zolbetuximab vials) or 5 mL (for 105 mg zolbetuximab vials). The reconstituted solution will be further diluted with sodium chloride 0.9% to a final concentration of 2 mg/mL zolbetuximab. Zolbetuximab will be administered as an intravenous infusion over 2 to 3 hours.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
PFS is defined as the time from randomization to the first observation of disease progression (based on central reading) or death from any cause (as assessed by the independent reviewer). Participants without documented progression or death will be censored as of the last tumor evaluation determining lack of progression.
Time Frame
From randomization to the data cut-off date of 31JAN2019; maximum time on follow-up was, 68.2, 47.2 & 59.6 months in the EOX, EOX+Zolbetuximab 600 mg, and EOX+Zolbetuximab 1000 mg treatment groups respectively.
Title
Number of Participants with Adverse Events (AEs)
Description
An AE is defined as any unintended or undesirable, noxious or pathological change, compared to pre-existing conditions, experienced by a participant during a clinical study or the follow-up period, regardless of relationship to study medication. Treatment-emergent adverse event (TEAE) are those AEs that started or worsened after the first dose of study medication.
Time Frame
From the first dose of study drug administration up to 30 days after the last study medication administration (up to 1791 days).
Secondary Outcome Measure Information:
Title
Clinical PFS
Description
Clinical PFS (CPFS) is defined as the time from randomization to the first observation of disease progression, either confirmed by computed tomography (CT) scans or by clinical evaluation, or death from any cause (as assessed by the independent reviewer with clinical PD considered as an event). Participants without documented progression or death will be censored as of the last tumor evaluation determining lack of progression.
Time Frame
From randomization to the data cut-off date of 31JAN2019; maximum time on follow-up was, 68.2, 47.2 & 59.6 months in the EOX, EOX+Zolbetuximab 600 mg, and EOX+Zolbetuximab 1000 mg treatment groups respectively.
Title
Overall Survival Rate at 12 Months
Description
Overall survival rate at 12 months after therapy initiation is defined as a proportion of participants alive after 12 months from first dose of any study drug.
Time Frame
Up to 12 months
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death from any cause or last contact (if alive).
Time Frame
From randomization to the data cut-off date of 31JAN2019; maximum time on follow-up was, 68.2, 47.2 & 59.6 months in the EOX, EOX+Zolbetuximab 600 mg, and EOX+Zolbetuximab 1000 mg treatment groups respectively.
Title
Time to Progression (TTP)
Description
TTP is defined as the time from randomization to the first observation of disease progression (based on central reading as assessed by the investigator reviewer). Participants without documented progression will be censored as of the last tumor evaluation determining lack of progression.
Time Frame
From randomization to the data cut-off date of 31JAN2019; maximum time on follow-up was, 68.2, 47.2 & 59.6 months in the EOX, EOX+Zolbetuximab 600 mg, and EOX+Zolbetuximab 1000 mg treatment groups respectively.
Title
Objective Tumor Response Rate (ORR)
Description
ORR is defined as the fraction of participants with a complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (as assessed by the investigator reviewer). CR according to RECIST v1.1 is defined as the disappearance of all target lesions, any pathological lymph node must have reduction in short axis to < 10 mm, disappearance of all non-target lesions and normalization of tumor marker level should occur as well as no simultaneous appearance of new lesions. PR according to RECIST v1.1 is defined as at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter and no simultaneous increase in the size of any lesion or the appearance of new lesions.
Time Frame
Up to week 94
Title
Disease Control Rate (DCR)
Description
DCR is defined as the fraction of participants with CR or PR or stable disease (SD) according to RECIST v1.1 (as assessed by the investigator reviewer). SD according to RECIST v1.1 is defined as neither sufficient shrinkage to qualify for PR or CR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter recorded since treatment started, measurements must meet the SD criteria at least once after study entry at a minimum interval not less than 6 weeks, no simultaneous increase in the size of any lesion or the appearance of new lesions should occur, evaluable lesions must remain stable or regress for this category.
Time Frame
Up to week 94
Title
Duration of Response (DOR)
Description
DOR will be determined as the time when criteria for CR or PR are first met until the first date that recurrent or progressive disease or death occurs (as assessed by the independent reviewer).
Time Frame
From randomization to the data cut-off date of 31JAN2019; maximum time on follow-up was, 68.2, 47.2 & 59.6 months in the EOX, EOX+Zolbetuximab 600 mg, and EOX+Zolbetuximab 1000 mg treatment groups respectively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction Inoperable locally advanced disease or resections with R2 outcome or recurrent or metastatic disease. CLDN18.2 expression confirmed by immunohistochemistry in paraffin embedded tumor tissue sample. Measurable and/or non-measurable disease as defined according to RECISTv1.1 Age ≥ 18 years Written Informed Consent Form ECOG performance status (PS) 0-1 Life expectancy > 3 months HER2/neu negative patients and patients with HER2/neu positive status but not eligible to trastuzumab therapy in discretion of the investigator. Adequate cardiac, hepatic, renal, hematologic function. Exclusion Criteria: Prior severe allergic reaction or intolerance to a monoclonal antibody, to the chemotherapeutics used in this study or any excipient in the respective formulations. Previous chemotherapy for advanced disease. Previous perioperative chemotherapy with curative intention within 6 months of start of study treatment. If interval is longer than 6 months (counted from the stop date of the perioperative chemotherapy), patients are allowed. Known HIV infection or known symptomatic hepatitis (A, B, C). Symptomatic cerebral metastases. Pregnancy or breastfeeding. Previous treatments with maximum cumulative doses of epirubicin > 500 mg/m² and/or other anthracyclines and anthracenediones. Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Executive Director
Organizational Affiliation
Astellas Pharma Global Development, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Site BUL004
City
Plovdiv
Country
Bulgaria
Facility Name
Site BUL001
City
Sofia
Country
Bulgaria
Facility Name
Site BUL003
City
Sofia
Country
Bulgaria
Facility Name
Site BUL005
City
Sofia
Country
Bulgaria
Facility Name
Site BUL002
City
Varna
Country
Bulgaria
Facility Name
Site CZE002
City
Olomouc
Country
Czechia
Facility Name
Site CZE001
City
Znojmo
Country
Czechia
Facility Name
Site GER012
City
Bielefeld
Country
Germany
Facility Name
Site GER029-01
City
Bochum
Country
Germany
Facility Name
Site GER029
City
Bochum
Country
Germany
Facility Name
Site GER010
City
Dresden
Country
Germany
Facility Name
Site GER001
City
Essen
Country
Germany
Facility Name
Site GER017
City
Frankfurt
Country
Germany
Facility Name
Site GER005
City
Halle/Saale
Country
Germany
Facility Name
Site GER020
City
Leipzig
Country
Germany
Facility Name
Site GER016
City
Münster
Country
Germany
Facility Name
Site GER013
City
Pinneberg
Country
Germany
Facility Name
Site LAT001
City
Liepaja
Country
Latvia
Facility Name
Site LAT002
City
Riga
Country
Latvia
Facility Name
Site RUS011
City
Arkhangelsk
Country
Russian Federation
Facility Name
Site RUS016
City
Bryansk
Country
Russian Federation
Facility Name
Site RUS006
City
Chelyabinsk
Country
Russian Federation
Facility Name
Site RUS007
City
Ivanovo
Country
Russian Federation
Facility Name
Site RUS009
City
Kursk
Country
Russian Federation
Facility Name
Site RUS001
City
Moscow
Country
Russian Federation
Facility Name
Site RUS017
City
Novgorod
Country
Russian Federation
Facility Name
Site RUS002
City
Obninsk
Country
Russian Federation
Facility Name
Site RUS023
City
Omsk
Country
Russian Federation
Facility Name
Site RUS012
City
Orel
Country
Russian Federation
Facility Name
Site RUS014
City
Orenburg
Country
Russian Federation
Facility Name
Site RUS005
City
Pyatigorsk
Country
Russian Federation
Facility Name
Site RUS019
City
Ryazan
Country
Russian Federation
Facility Name
Site RUS003
City
St.Petersburg
Country
Russian Federation
Facility Name
Site RUS010
City
St.Petersburg
Country
Russian Federation
Facility Name
Site RUS015
City
St.Petersburg
Country
Russian Federation
Facility Name
Site RUS013
City
Yaroslavl
Country
Russian Federation
Facility Name
Site UKR003
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Site UKR001
City
Donetsk
Country
Ukraine
Facility Name
Site UKR002
City
Donetsk
Country
Ukraine
Facility Name
Site UKR008
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Site UKR005
City
Kharkiv
Country
Ukraine
Facility Name
Site UKR007
City
Kyiv
Country
Ukraine
Facility Name
Site UKR006
City
Lviv
Country
Ukraine
Facility Name
Site UKR015
City
Poltava
Country
Ukraine
Facility Name
Site UKR004
City
Simferopol
Country
Ukraine
Facility Name
Site UKR011
City
Sumy
Country
Ukraine
Facility Name
Site UKR010
City
Uzhhorod
Country
Ukraine
Facility Name
Site UKR009
City
Zaporizhia
Country
Ukraine

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

Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer

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