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New drug combo offers hope for Hard-to-Treat stomach cancer

NCT ID NCT06048081

Disease control Sponsor: Astellas Pharma Global Development, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access This study
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This program provides early access to zolbetuximab, a targeted drug, combined with standard chemotherapy for people with advanced stomach or gastroesophageal junction cancer that has a specific protein (CLDN18.2). Participants must not have had prior chemotherapy or immunotherapy. The goal is to offer treatment before the drug is fully approved, while monitoring side effects and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zolbetuximab (a drug given by IV infusion, plus chemotherapy)
What this could lead to
If this program shows positive results, it could support the approval of zolbetuximab as a new treatment option for people with this specific type of stomach cancer.
What could go wrong
This is an early access program, not a formal trial, so data is limited. The drug may cause side effects, and not all patients will benefit. It is only for those with a specific tumor marker (CLDN18.2).

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma gastric adenocarcinoma gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced unresectable gastric adenocarcinoma cancer Locally advanced unresectable gastroesophageal junction (GEJ) adenocarcinoma cancer Metastatic gastric adenocarcinoma cancer Metastatic gastroesophageal junction (GEJ) adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    140 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BR55001

    AVAILABLE

    Belo Horizonte, Brazil

  • BR55002

    AVAILABLE

    Florianópolis, Brazil

  • BR55003

    AVAILABLE

    Rio de Janeiro, Brazil

  • BR55004

    AVAILABLE

    Brasília, Brazil

  • BR55005

    AVAILABLE

    Porto Alegre, Brazil

  • BR55006

    AVAILABLE

    São Paulo, Brazil

  • BR55007

    AVAILABLE

    Londrina, Brazil

  • BR55008

    AVAILABLE

    Natal, Brazil

  • BR55009

    AVAILABLE

    Belém, Brazil

  • BR55010

    AVAILABLE

    Manaus, Brazil

  • DE 49005

    AVAILABLE

    München, Germany

  • DE49001

    AVAILABLE

    Tübingen, Germany

  • DE49002

    AVAILABLE

    Ulm, Germany

  • DE49003

    AVAILABLE

    Göttingen, Germany

  • DE49004

    AVAILABLE

    Damme, Germany

  • DE49006

    AVAILABLE

    Erkelenz, Germany

  • DE49007

    AVAILABLE

    Hamburg, Germany

  • DE49008

    AVAILABLE

    Kiel, Germany

  • DE49010

    AVAILABLE

    Munich, Germany

  • DE49011

    AVAILABLE

    Viersen, Germany

  • DE49012

    AVAILABLE

    Nuremberg, Germany

  • DE49016

    AVAILABLE

    Wiesbaden, Germany

  • DE49017

    AVAILABLE

    Frankfurt am Main, Germany

  • DE49018

    AVAILABLE

    Frankfurt, Germany

  • DE49019

    AVAILABLE

    Magdeburg, Germany

  • DE49020

    AVAILABLE

    Berlin, Germany

  • DE49021

    AVAILABLE

    Chemnitz, Germany

  • DE49022

    AVAILABLE

    Kempten, Germany

  • DE49023

    AVAILABLE

    Koblenz, Germany

  • DE49024

    AVAILABLE

    Kiel, Germany

  • DE49025

    AVAILABLE

    Ravensburg, Germany

  • DE49029

    AVAILABLE

    Essen, Germany

  • DE49030

    AVAILABLE

    Erkelenz, Germany

  • DE49032

    AVAILABLE

    Thuine, Germany

  • DE49033

    AVAILABLE

    Hamburg, Germany

  • DE49034

    AVAILABLE

    Damme, Germany

  • FR33001

    AVAILABLE

    Marseille, France

  • FR33002

    AVAILABLE

    Vannes, France

  • FR33003

    AVAILABLE

    Lyon, France

  • FR33004

    AVAILABLE

    Angers, France

  • FR33005

    AVAILABLE

    Suresnes, France

  • FR33006

    AVAILABLE

    Paris, France

  • FR33007

    AVAILABLE

    Bordeaux, France

  • FR33008

    AVAILABLE

    Montpellier, France

  • FR33009

    AVAILABLE

    Suresnes, France

  • FR33010

    AVAILABLE

    Angers, France

  • FR33011

    AVAILABLE

    Paris, France

  • FR33012

    AVAILABLE

    Périgueux, France

  • FR33013

    AVAILABLE

    Clermont-Ferrand, France

  • FR33014

    AVAILABLE

    Lormont, France

  • FR33015

    AVAILABLE

    Bordeaux, France

  • FR33016

    AVAILABLE

    Rodez, France

  • FR33017

    AVAILABLE

    Paris, France

  • FR33018

    AVAILABLE

    St-Malo, France

  • FR33019

    AVAILABLE

    Villejuif, France

  • FR33020

    AVAILABLE

    Le Blanc-Mesnil, France

  • FR33021

    AVAILABLE

    Cagnes-sur-Mer, France

  • FR33022

    AVAILABLE

    Perpignan, France

  • FR33023

    AVAILABLE

    Saint-Grégoire, France

  • FR33024

    AVAILABLE

    Clermont-Ferrand, France

  • FR33025

    AVAILABLE

    Brest, France

  • FR33026

    AVAILABLE

    Colmar, France

  • FR33027

    AVAILABLE

    Villejuif, France

  • FR33028

    AVAILABLE

    Avignon, France

  • FR33029

    AVAILABLE

    Corbeil-Essonnes, France

  • FR33030

    AVAILABLE

    Vantoux, France

  • FR33031

    AVAILABLE

    Lyon, France

  • FR33032

    AVAILABLE

    Nantes, France

  • FR33033

    AVAILABLE

    Paris, France

  • FR33034

    AVAILABLE

    Paris, France

  • FR33035

    AVAILABLE

    Niort, France

  • FR33036

    AVAILABLE

    Trévenans, France

  • FR33037

    AVAILABLE

    Rouen, France

  • FR33038

    AVAILABLE

    Poitiers, France

  • FR33039

    AVAILABLE

    Grenoble, France

  • FR33040

    AVAILABLE

    Bobigny, France

  • FR33041

    AVAILABLE

    Tours, France

  • FR33042

    AVAILABLE

    Bayeux, France

  • FR33043

    AVAILABLE

    Lille, France

  • FR33044

    AVAILABLE

    Tourcoing, France

  • FR33045

    AVAILABLE

    Marseille, France

  • FR33046

    AVAILABLE

    Brieuc, France

  • FR33047

    AVAILABLE

    Moulins, France

  • FR33048

    AVAILABLE

    Quincy-sous-Sénart, France

  • FR33049

    AVAILABLE

    Morlaix, France

  • FR33050

    AVAILABLE

    Mantes-la-Jolie, France

  • FR33051

    AVAILABLE

    Valenciennes, France

  • FR33052

    AVAILABLE

    Villejuif, France

  • FR33053

    AVAILABLE

    Gregoire, France

  • FR33054

    AVAILABLE

    Aubagne, France

  • FR33055

    AVAILABLE

    Tours, France

  • FR33056

    AVAILABLE

    Saint-Nazaire, France

  • FR33057

    AVAILABLE

    Suresnes, France

  • FR33058

    AVAILABLE

    Reims, France

  • FR33059

    AVAILABLE

    Saint-Etienne, France

  • FR33060

    AVAILABLE

    Sallanches, France

  • FR33061

    AVAILABLE

    Créteil, France

  • FR33062

    AVAILABLE

    Caen, France

  • FR33063

    AVAILABLE

    Loches, France

  • FR33064

    AVAILABLE

    La Rochelle, France

  • FR33065

    AVAILABLE

    Compiègne, France

  • FR33066

    AVAILABLE

    Saint-Priest-en-Jarez, France

  • FR33067

    AVAILABLE

    Saint-Quentin, France

  • FR33068

    AVAILABLE

    Plérin, France

  • FR33069

    AVAILABLE

    Dechy, France

  • FR33070

    AVAILABLE

    Troyes, France

  • FR33071

    AVAILABLE

    Salon-de-Provence, France

  • FR33072

    AVAILABLE

    Thonon-les-Bains, France

  • FR33073

    AVAILABLE

    Cagnes-sur-Mer, France

  • FR33074

    AVAILABLE

    Brive-la-Gaillarde, France

  • FR33075

    AVAILABLE

    Montpellier, France

  • FR33076

    AVAILABLE

    Rennes, France

  • FR33077

    AVAILABLE

    Verdun, France

  • FR33078

    AVAILABLE

    Nice, France

  • FR33079

    AVAILABLE

    Saint-Jean-de-Verges, France

  • FR33080

    AVAILABLE

    Pau, France

  • FR33081

    AVAILABLE

    Rouen, France

  • FR33082

    AVAILABLE

    Saint-Priest-en-Jarez, France

  • FR33083

    AVAILABLE

    Creil, France

  • FR33084

    AVAILABLE

    Limoges, France

  • FR33085

    AVAILABLE

    Saint-Martin-d'Hères, France

  • FR33086

    AVAILABLE

    Cholet, France

  • KR82001

    AVAILABLE

    Seoul, South Korea

  • KR82002

    AVAILABLE

    Seoul, South Korea

  • KR82003

    AVAILABLE

    Seoul, South Korea

  • KR82004

    AVAILABLE

    Incheon, South Korea

  • KR82005

    AVAILABLE

    Yangsan, South Korea

  • KR82006

    AVAILABLE

    Seoul, South Korea

  • KR82007

    AVAILABLE

    Seoul, South Korea

  • KR82008

    AVAILABLE

    Seongnam-si, South Korea

  • KR82009

    AVAILABLE

    Suwon, South Korea

  • KR82010

    AVAILABLE

    Suwon, South Korea

  • KR82011

    AVAILABLE

    Ulsan, South Korea

  • SG65001

    AVAILABLE

    Singapore, Singapore

  • SG65002

    AVAILABLE

    Singapore, Singapore

  • SG65003

    AVAILABLE

    Singapore, Singapore

  • SG65004

    AVAILABLE

    Singapore, Singapore

  • SG65005

    AVAILABLE

    Singapore, Singapore

  • SG65006

    AVAILABLE

    Singapore, Singapore

  • Site US10001

    AVAILABLE

    Morristown, New Jersey, 07960, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.