Early Access Program for Zolbetuximab
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
1 other identifier
expanded_access
N/A
6 countries
140
Brief 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). 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
140 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedSeptember 10, 2025
September 1, 2025
September 15, 2023
September 9, 2025
Conditions
Keywords
Interventions
intravenous infusion mFOLFOX6 or CAPOX (used at physician discretion) will be used in combination with zolbetuximab
Eligibility Criteria
You may qualify if:
- 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:
- +7 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (140)
Site US10001
Morristown, New Jersey, 07960, United States
BR55009
Belém, Brazil
BR55001
Belo Horizonte, Brazil
BR55004
Brasília, Brazil
BR55002
Florianópolis, Brazil
BR55007
Londrina, Brazil
BR55010
Manaus, Brazil
BR55008
Natal, Brazil
BR55005
Porto Alegre, Brazil
BR55003
Rio de Janeiro, Brazil
BR55006
São Paulo, Brazil
FR33004
Angers, France
FR33010
Angers, France
FR33054
Aubagne, France
FR33028
Avignon, France
FR33042
Bayeux, France
FR33040
Bobigny, France
FR33007
Bordeaux, France
FR33015
Bordeaux, France
FR33025
Brest, France
FR33046
Brieuc, France
FR33074
Brive-la-Gaillarde, France
FR33062
Caen, France
FR33021
Cagnes-sur-Mer, France
FR33073
Cagnes-sur-Mer, France
FR33086
Cholet, France
FR33013
Clermont-Ferrand, France
FR33024
Clermont-Ferrand, France
FR33026
Colmar, France
FR33065
Compiègne, France
FR33029
Corbeil-Essonnes, France
FR33083
Creil, France
FR33061
Créteil, France
FR33069
Dechy, France
FR33053
Gregoire, France
FR33039
Grenoble, France
FR33064
La Rochelle, France
FR33020
Le Blanc-Mesnil, France
FR33043
Lille, France
FR33084
Limoges, France
FR33063
Loches, France
FR33014
Lormont, France
FR33003
Lyon, France
FR33031
Lyon, France
FR33050
Mantes-la-Jolie, France
FR33001
Marseille, France
FR33045
Marseille, France
FR33008
Montpellier, France
FR33075
Montpellier, France
FR33049
Morlaix, France
FR33047
Moulins, France
FR33032
Nantes, France
FR33078
Nice, France
FR33035
Niort, France
FR33006
Paris, France
FR33011
Paris, France
FR33017
Paris, France
FR33033
Paris, France
FR33034
Paris, France
FR33080
Pau, France
FR33022
Perpignan, France
FR33012
Périgueux, France
FR33068
Plérin, France
FR33038
Poitiers, France
FR33048
Quincy-sous-Sénart, France
FR33058
Reims, France
FR33076
Rennes, France
FR33016
Rodez, France
FR33037
Rouen, France
FR33081
Rouen, France
FR33059
Saint-Etienne, France
FR33023
Saint-Grégoire, France
FR33079
Saint-Jean-de-Verges, France
FR33085
Saint-Martin-d'Hères, France
FR33056
Saint-Nazaire, France
FR33066
Saint-Priest-en-Jarez, France
FR33082
Saint-Priest-en-Jarez, France
FR33067
Saint-Quentin, France
FR33060
Sallanches, France
FR33071
Salon-de-Provence, France
FR33018
St-Malo, France
FR33005
Suresnes, France
FR33009
Suresnes, France
FR33057
Suresnes, France
FR33072
Thonon-les-Bains, France
FR33044
Tourcoing, France
FR33041
Tours, France
FR33055
Tours, France
FR33036
Trévenans, France
FR33070
Troyes, France
FR33051
Valenciennes, France
FR33002
Vannes, France
FR33030
Vantoux, France
FR33077
Verdun, France
FR33019
Villejuif, France
FR33027
Villejuif, France
FR33052
Villejuif, France
DE49020
Berlin, Germany
DE49021
Chemnitz, Germany
DE49004
Damme, Germany
DE49034
Damme, Germany
DE49006
Erkelenz, Germany
DE49030
Erkelenz, Germany
DE49029
Essen, Germany
DE49018
Frankfurt, Germany
DE49017
Frankfurt am Main, Germany
DE49003
Göttingen, Germany
DE49007
Hamburg, Germany
DE49033
Hamburg, Germany
DE49022
Kempten, Germany
DE49008
Kiel, Germany
DE49024
Kiel, Germany
DE49023
Koblenz, Germany
DE49019
Magdeburg, Germany
DE49010
Munich, Germany
DE 49005
München, Germany
DE49012
Nuremberg, Germany
DE49025
Ravensburg, Germany
DE49032
Thuine, Germany
DE49001
Tübingen, Germany
DE49002
Ulm, Germany
DE49011
Viersen, Germany
DE49016
Wiesbaden, Germany
SG65001
Singapore, Singapore
SG65002
Singapore, Singapore
SG65003
Singapore, Singapore
SG65004
Singapore, Singapore
SG65005
Singapore, Singapore
SG65006
Singapore, Singapore
KR82004
Incheon, South Korea
KR82008
Seongnam-si, South Korea
KR82001
Seoul, South Korea
KR82002
Seoul, South Korea
KR82003
Seoul, South Korea
KR82006
Seoul, South Korea
KR82007
Seoul, South Korea
KR82009
Suwon, South Korea
KR82010
Suwon, South Korea
KR82011
Ulsan, South Korea
KR82005
Yangsan, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development, Inc.