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Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma CancerNCT06048081

Early Access Program for Zolbetuximab

A study testing zolbetuximab in people with Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer and Locally Advanced Unresectable Gastric Adenocarcinoma Cancer, run by Astellas Pharma Global Development, Inc. at 140 sites in 6 countries.

Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This program is to provide zolbetuximab to people with stomach cancer or gastroesophageal junction (the junction between stomach and esophagus) cancer who have not yet been treated with chemotherapy, immunotherapy, or zolbetuximab and who have tested positive for claudin18.2 (a protein found in some cancer cells). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
zolbetuximab
Type of treatment
Injection or infusion
How many people
Not given
Where
140 sitesin 6 countries
Study dates
Start not givento not given
Phase
Expanded access
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
  • Adult, Older adult

Who may be able to join

  • Patient has histologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
  • Patient has confirmed locally advanced, unresectable or metastatic gastric or GEJ adenocarcinoma.
  • Patient whose tumor expresses claudin18.2 (CLDN18.2) in ≥ 75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining as determined by local or central immunohistochemistry (IHC) testing.
  • Patient has a Human epidermal growth factor receptor 2 (HER2-negative) tumor by local testing on a gastric or GEJ tumor specimen.
  • Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Patient must meet all of the following criteria based on the locally analyzed laboratory tests collected.
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  • Hemoglobin (Hgb) ≥ 9 g/dL. Patients requiring transfusions are eligible if they have post-transfusion Hgb ≥ 9 g/dL.
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
  • Platelets ≥ 100 × 109/L
  • Albumin ≥ 2.5 g/dL
  • Total bilirubin (TBL) ≤ 1.5 × ULN without liver metastases (or < 3.0 × ULN if liver metastases are present)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) without liver metastases (or ≤ 5 × ULN if liver metastases are present)
  • Estimated creatinine clearance ≥ 30 mL/min
  • Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time ≤ 1.5 × ULN (except for patients receiving anticoagulation therapy)
  • Female patient is not pregnant and at least 1 of the following conditions apply:
  • Not a woman of child bearing potential (WOCBP)
  • WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 9 months after the final administration of oxaliplatin and 6 months after final administration of other interventions.
  • Female patient must agree not to breastfeed starting at screening and throughout the EAP period and for 6 months after final intervention administration.
  • Female patient must not donate ova starting at first administration of treatment and throughout the EAP period and for 9 months after the final administration of oxaliplatin and 6 months after final administration of other interventions.
  • Male patient with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 6 months after final treatment administration.
  • Male patient must not donate sperm during the treatment period and for 6 months after final treatment administration.
  • Male patient with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the EAP period and for 6 months after final treatment administration.

Who cannot join

  • Patient has previously received treatment in a clinical trial of zolbetuximab, or a clinical trial that included zolbetuximab as 1 of the treatment options, even if the patient was not given zolbetuximab.
  • Patient is a candidate for an ongoing clinical trial of zolbetuximab.
  • Patient has received any investigational therapy within 28 days or 5 half-lives prior to screening.
  • Patient has a known or suspected hypersensitivity to zolbetuximab, other monoclonal antibodies or any components of the formulation used.
  • Patient has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, patient 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 participation.
  • Patient has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma ≤ 14 days prior to program registration and has not recovered from any related toxicity.
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  • Patient receiving treatment with herbal medications that have known antitumor activity.
  • Patient has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to registration. Patients using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg/day of hydrocortisone or up to 10 mg/day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed.
  • Patient has a prior severe allergic reaction, known (immediate or delayed) or suspected hypersensitivity, intolerance or contraindication to zolbetuximab, mFOLFOX6, CAPOX, other monoclonal antibodies or any components of the formulations used.
  • Patient has known dihydropyrimidine dehydrogenase (DPD) deficiency. (NOTE: Screening for DPD deficiency should be conducted per local requirements.)
  • Patient has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.
  • Patient has significant gastric bleeding and/or untreated gastric ulcers that would exclude the patient from participation.
  • Patient has any other condition, which makes the patient unsuitable to receive or tolerate zolbetuximab.

Trial locations and contacts

140 sites in 6 countries.

Astellas Global Development, Inc. contact

800-888-7704;

Astellas.registration@astellas.com

140 sites in 6 countries

France86 sites

  • FR33004

    Angers

    Available

  • FR33010

    Angers

    Available

  • FR33054

    Aubagne

    Available

  • FR33028

    Avignon

    Available

  • FR33042

    Bayeux

    Available

  • FR33040

    Bobigny

    Available

  • FR33007

    Bordeaux

    Available

  • FR33015

    Bordeaux

    Available

  • FR33025

    Brest

    Available

  • FR33046

    Brieuc

    Available

  • FR33074

    Brive-la-Gaillarde

    Available

  • FR33062

    Caen

    Available

  • FR33021

    Cagnes-sur-Mer

    Available

  • FR33073

    Cagnes-sur-Mer

    Available

  • FR33086

    Cholet

    Available

  • FR33013

    Clermont-Ferrand

    Available

  • FR33024

    Clermont-Ferrand

    Available

  • FR33026

    Colmar

    Available

  • FR33065

    Compiègne

    Available

  • FR33029

    Corbeil-Essonnes

    Available

  • FR33083

    Creil

    Available

  • FR33061

    Créteil

    Available

  • FR33069

    Dechy

    Available

  • FR33053

    Gregoire

    Available

  • FR33039

    Grenoble

    Available

  • FR33064

    La Rochelle

    Available

  • FR33020

    Le Blanc-Mesnil

    Available

  • FR33043

    Lille

    Available

  • FR33084

    Limoges

    Available

  • FR33063

    Loches

    Available

  • FR33014

    Lormont

    Available

  • FR33003

    Lyon

    Available

  • FR33031

    Lyon

    Available

  • FR33050

    Mantes-la-Jolie

    Available

  • FR33001

    Marseille

    Available

  • FR33045

    Marseille

    Available

  • FR33008

    Montpellier

    Available

  • FR33075

    Montpellier

    Available

  • FR33049

    Morlaix

    Available

  • FR33047

    Moulins

    Available

  • FR33032

    Nantes

    Available

  • FR33078

    Nice

    Available

  • FR33035

    Niort

    Available

  • FR33006

    Paris

    Available

  • FR33011

    Paris

    Available

  • FR33017

    Paris

    Available

  • FR33033

    Paris

    Available

  • FR33034

    Paris

    Available

  • FR33080

    Pau

    Available

  • FR33012

    Périgueux

    Available

  • FR33022

    Perpignan

    Available

  • FR33068

    Plérin

    Available

  • FR33038

    Poitiers

    Available

  • FR33048

    Quincy-sous-Sénart

    Available

  • FR33058

    Reims

    Available

  • FR33076

    Rennes

    Available

  • FR33016

    Rodez

    Available

  • FR33037

    Rouen

    Available

  • FR33081

    Rouen

    Available

  • FR33059

    Saint-Etienne

    Available

  • FR33023

    Saint-Grégoire

    Available

  • FR33079

    Saint-Jean-de-Verges

    Available

  • FR33085

    Saint-Martin-d'Hères

    Available

  • FR33056

    Saint-Nazaire

    Available

  • FR33066

    Saint-Priest-en-Jarez

    Available

  • FR33082

    Saint-Priest-en-Jarez

    Available

  • FR33067

    Saint-Quentin

    Available

  • FR33060

    Sallanches

    Available

  • FR33071

    Salon-de-Provence

    Available

  • FR33018

    St-Malo

    Available

  • FR33005

    Suresnes

    Available

  • FR33009

    Suresnes

    Available

  • FR33057

    Suresnes

    Available

  • FR33072

    Thonon-les-Bains

    Available

  • FR33044

    Tourcoing

    Available

  • FR33041

    Tours

    Available

  • FR33055

    Tours

    Available

  • FR33036

    Trévenans

    Available

  • FR33070

    Troyes

    Available

  • FR33051

    Valenciennes

    Available

  • FR33002

    Vannes

    Available

  • FR33030

    Vantoux

    Available

  • FR33077

    Verdun

    Available

  • FR33019

    Villejuif

    Available

  • FR33027

    Villejuif

    Available

  • FR33052

    Villejuif

    Available

Other trials in France

Germany26 sites

  • DE49020

    Berlin

    Available

  • DE49021

    Chemnitz

    Available

  • DE49004

    Damme

    Available

  • DE49034

    Damme

    Available

  • DE49006

    Erkelenz

    Available

  • DE49030

    Erkelenz

    Available

  • DE49029

    Essen

    Available

  • DE49018

    Frankfurt

    Available

  • DE49017

    Frankfurt am Main

    Available

  • DE49003

    Göttingen

    Available

  • DE49007

    Hamburg

    Available

  • DE49033

    Hamburg

    Available

  • DE49022

    Kempten

    Available

  • DE49008

    Kiel

    Available

  • DE49024

    Kiel

    Available

  • DE49023

    Koblenz

    Available

  • DE49019

    Magdeburg

    Available

  • DE 49005

    München

    Available

  • DE49010

    Munich

    Available

  • DE49012

    Nuremberg

    Available

  • DE49025

    Ravensburg

    Available

  • DE49032

    Thuine

    Available

  • DE49001

    Tübingen

    Available

  • DE49002

    Ulm

    Available

  • DE49011

    Viersen

    Available

  • DE49016

    Wiesbaden

    Available

Other trials in Germany

South Korea11 sites

  • KR82004

    Incheon

    Available

  • KR82008

    Seongnam-si

    Available

  • KR82001

    Seoul

    Available

  • KR82002

    Seoul

    Available

  • KR82003

    Seoul

    Available

  • KR82006

    Seoul

    Available

  • KR82007

    Seoul

    Available

  • KR82009

    Suwon

    Available

  • KR82010

    Suwon

    Available

  • KR82011

    Ulsan

    Available

  • KR82005

    Yangsan

    Available

Other trials in South Korea

Brazil10 sites

  • BR55009

    Belém

    Available

  • BR55001

    Belo Horizonte

    Available

  • BR55004

    Brasília

    Available

  • BR55002

    Florianópolis

    Available

  • BR55007

    Londrina

    Available

  • BR55010

    Manaus

    Available

  • BR55008

    Natal

    Available

  • BR55005

    Porto Alegre

    Available

  • BR55003

    Rio de Janeiro

    Available

  • BR55006

    São Paulo

    Available

Other trials in Brazil

Singapore6 sites

  • SG65001

    Singapore

    Available

  • SG65002

    Singapore

    Available

  • SG65003

    Singapore

    Available

  • SG65004

    Singapore

    Available

  • SG65005

    Singapore

    Available

  • SG65006

    Singapore

    Available

Other trials in Singapore

United States1 site

  • Site US10001

    Morristown, New Jersey, 07960

    Available

Other trials in United States

About this study

Official title: A Global, Multicenter, Open-label, Early Access Program for Zolbetuximab (IMAB362) Plus mFOLFOX6 or CAPOX in Patients With Claudin18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

This program is to provide zolbetuximab to people with stomach cancer or gastroesophageal junction (the junction between stomach and esophagus) cancer who have not yet been treated with chemotherapy, immunotherapy, or zolbetuximab and who have tested positive for claudin18.2 (a protein found in some cancer cells). People will work with their doctor to see if they are capable of being treated with zolbetuximab while they receive other standard medicines to treat their cancer. The program will allow people early access to zolbetuximab before the drug is fully approved.

Zolbetuximab will be given through a vein. This is called an infusion. The infusion will happen during a person's treatment with other cancer medicines. Zolbetuximab will be given every 3 weeks. People will continue treatment until: they have medical problems (unwanted side effects) from the treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; or they do not come back for treatment.

Read more

People will visit the clinic on certain days during their treatment. During these visits, the program doctors will check for any medical problems (unwanted side effects) from zolbetuximab, other cancer treatment, or both. At some visits, other checks will include a medical examination, laboratory tests and vital signs. Vital signs include temperature, pulse, and blood pressure. Also, blood samples will be taken.

People will visit the clinic within 7 days after stopping treatment. The program doctors will check for any medical problems (unwanted side effects) from zolbetuximab or their cancer treatment. Other checks will include a medical examination, laboratory tests, and vital signs. Then, people will have a follow-up visit about 30 days after stopping treatment. If people are having no health problems, the follow-up visit can happen over the telephone.

Read the detailed description

The European Union European Medicines Agency, the United States Food and Drug Administration, and South Korea Pharmaceuticals and Medical Devices Agency have approved zolbetuximab for the treatment of advanced stomach/GEJ cancer in adults. Enrollment is closed in United States, and Germany.

Being tested
zolbetuximab
Keywords
Zolbetuximab, IMAB362, Modified oxaliplatin, folinic acid (leucovorin) and fluorouracim (FOLFOX6), Capecitabine and oxaliplatin (CAPOX), Early Access Program (EAP), Human epidermal growth factor receptor 2 (HER2) Negative, Claudin 18.2
Medical subject headings
Adenocarcinoma

What participants receive

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

  • zolbetuximabDrug

    Also called IMAB362

    intravenous infusion

    mFOLFOX6 or CAPOX (used at physician discretion) will be used in combination with zolbetuximab

Timeline

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

  1. First posted21 Sep 2023

Resources

More details

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

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT06048081
Sponsor's protocol ID
8951-CL-9100
Status last verified
Sep 2025
First submitted
15 Sep 2023
Last updated
10 Sep 2025
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing zolbetuximab in people with Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer and Locally Advanced Unresectable Gastric Adenocarcinoma Cancer, run by Astellas Pharma Global Development, Inc. at 140 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 22 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in France, Germany, South Korea, Brazil, Singapore 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.

Are results available for this study?

Results are not available in the source record.

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

Contact Astellas Global Development, Inc. (800-888-7704;, Astellas.registration@astellas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06048081.

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 10 Sep 2025.

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