AzTrials
AzTrials

CLDN18.2-positive Adenocarcinoma of the Gastroesophageal JunctionPhase 2FASTNCT01630083

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

A Phase 2 study testing epirubicin, oxaliplatin and capecitabine in people with CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction and CLDN18.2-positive Adenocarcinoma of Esophagus, run by Astellas Pharma Global Development, Inc. at 48 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
epirubicin, oxaliplatin and capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
48 sitesin 6 countries
Study dates
19 Jul 2012to 31 Jan 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

48 sites in 6 countries.

48 sites in 6 countries

Russia17 sites

  • Site RUS011

    Arkhangelsk

  • Site RUS016

    Bryansk

  • Site RUS006

    Chelyabinsk

  • Site RUS007

    Ivanovo

  • Site RUS009

    Kursk

  • Site RUS001

    Moscow

  • Site RUS002

    Obninsk

  • Site RUS023

    Omsk

  • Site RUS014

    Orenburg

  • Site RUS012

    Oryol

  • Site RUS005

    Pyatigorsk

  • Site RUS019

    Ryazan

  • Site RUS003

    Saint Petersburg

  • Site RUS010

    Saint Petersburg

  • Site RUS015

    Saint Petersburg

  • Site RUS017

    Velikiy Novgorod

  • Site RUS013

    Yaroslavl

Other trials in Russia

Ukraine12 sites

  • Site UKR003

    Dnipropetrovsk

  • Site UKR001

    Donetsk

  • Site UKR002

    Donetsk

  • Site UKR008

    Ivano-Frankivsk

  • Site UKR005

    Kharkiv

  • Site UKR007

    Kyiv

  • Site UKR006

    Lviv

  • Site UKR015

    Poltava

  • Site UKR004

    Simferopol

  • Site UKR011

    Sumy

  • Site UKR010

    Uzhhorod

  • Site UKR009

    Zaporizhia

Other trials in Ukraine

Germany10 sites

  • Site GER012

    Bielefeld

  • Site GER029-01

    Bochum

  • Site GER029

    Bochum

  • Site GER010

    Dresden

  • Site GER001

    Essen

  • Site GER017

    Frankfurt

  • Site GER005

    Halle

  • Site GER020

    Leipzig

  • Site GER016

    Münster

  • Site GER013

    Pinneberg

Other trials in Germany

Bulgaria5 sites

  • Site BUL004

    Plovdiv

  • Site BUL001

    Sofia

  • Site BUL003

    Sofia

  • Site BUL005

    Sofia

  • Site BUL002

    Varna

Other trials in Bulgaria

Czechia2 sites

  • Site CZE002

    Olomouc

  • Site CZE001

    Znojmo

Other trials in Czechia

Latvia2 sites

  • Site LAT001

    Liepāja

  • Site LAT002

    Riga

Other trials in Latvia

About this study

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

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.

Being tested
epirubicin, oxaliplatin, capecitabine, zolbetuximab
Keywords
IMAB362, ASP8951, zolbetuximab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • epirubicinDrug

    Epirubicin will be administered at a dose of 50 mg/m^2 as a 15-minute intravenous infusion on day 1 of each cycle.

  • oxaliplatinDrug

    Oxaliplatin will be administered at a dose of 130 mg/m^2 as a 2-hour intravenous infusion on day 1 of each cycle.

  • capecitabineDrug

    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.

  • zolbetuximabDrug

    Also called IMAB362

    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.

Study groups in NCT01630083
Study groupRoleWhat they receive
EOX TreatmentActive comparatorParticipants 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.
Receives: Drug: epirubicin; Drug: oxaliplatin; Drug: capecitabine
EOX+zolbetuximab 800/600 mg/m^2ExperimentalParticipants 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.
Receives: Drug: epirubicin; Drug: oxaliplatin; Drug: capecitabine; Drug: zolbetuximab
EOX+zolbetuximab 1000 mg/m^2ExperimentalParticipants 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.
Receives: Drug: epirubicin; Drug: oxaliplatin; Drug: capecitabine; Drug: zolbetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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.

  2. 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.

    Measured: From the first dose of study drug administration up to 30 days after the last study medication administration (up to 1791 days).

Secondary outcomes (7)

  1. 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.

    Measured: 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.

  2. 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.

    Measured: Up to 12 months

  3. Overall Survival (OS)

    OS is defined as the time from randomization to death from any cause or last contact (if alive).

    Measured: 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.

  4. 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.

    Measured: 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.

  5. 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.

    Measured: Up to week 94

  6. 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.

    Measured: Up to week 94

  7. 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).

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2012 (estimated)
  2. Study start19 Jul 2012
  3. Primary completion31 Jan 2019
  4. Study completion31 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01630083
Sponsor's protocol ID
GM-IMAB-001-03
Other IDs
2011-005285-38, 8951-CL-0202
Acronym
FAST
Status last verified
Jun 2025
First submitted
19 Jun 2012
Last updated
15 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing epirubicin, oxaliplatin and capecitabine in people with CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction and CLDN18.2-positive Adenocarcinoma of Esophagus, run by Astellas Pharma Global Development, Inc. at 48 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Russia, Ukraine, Germany, Bulgaria, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01630083.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in