A Study of Zolbetuximab Given With mFOLFOX6 or CAPOX Chemotherapy in Indian Adults With Gastric Cancer

NCT07829757 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 8951-CL-4001
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

There is an unmet medical need to treat people with advanced cancer in the stomach and the junction area where the stomach joins the food pipe. These conditions are known as advanced or stomach (gastric) cancer and advanced gastroesophageal junction cancer (GEJ cancer for short). Zolbetuximab is an approved treatment in many countries for people with advanced stomach cancer and advanced GEJ cancer. Some people with these cancers have a protein called Claudin 18.2 on their tumor but they do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative). Zolbetuximab works by attaching to the Claudin 18.2 protein on their tumor. This switches on the body's immune system to attack the tumor. In India, the standard chemotherapies used are mFOLFOX6 or CAPOX. The main aim of the study is to check the safety of zolbetuximab when given with mFOLFOX6 or CAPOX chemotherapies in people in India with advanced stomach or GEJ cancer. It will also check how well zolbetuximab controls stomach cancer and GEJ cancer when given with mFOLFOX6 or CAPOX.

Conditions

Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer; Metastatic Gastric Adenocarcinoma or Cancer; Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer; Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

Keywords

HER2; IMAB362; leucovorin; fluorouracil; Gastric cancer; zolbetuximab; oxaliplatin; adenocarcinoma; Gastroesophageal Junction cancer; HER2 Negative; mFOLFOX6; CAPOX; capecitabine

Outcome Measures

Primary Outcomes (4)

• Number of participants with adverse events (AEs)

  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.

  Up to 32 months

• Number of participants with laboratory assessments abnormalities and/or AEs

  Number of participants with potentially clinically significant laboratory values.

  Up to 32 months

• Number of participants with vital sign abnormalities and/or AEs

  Number of participants with potentially clinically significant vital sign values.

  Up to 32 months

• Number of Participants at each Eastern Cooperative Oncology Group (ECOG) performance status score

  The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.

  Up to 29 months

Secondary Outcomes (2)

• Objective response rate (ORR)

  Up to 29 months

• Duration of response (DOR)

  Up to 29 months

Study Arms (1)

Zolbetuximab Plus mFOLFOX6 or CAPOX

EXPERIMENTAL

Participants will receive an intravenous (IV) infusion of zolbetuximab at a loading dose of 800 mg/m\^2 on Cycle 1 Day 1 (C1D1) followed by 400 mg/m\^2 every 2 weeks if combined with mFOLFOX6 or 600 mg/m\^2 every 3 weeks if combined with CAPOX. Participants will receive chemotherapy over 4 or more cycles of either up to 12 mFOLFOX6 treatments (oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2, 5-fluorouracil \[FU\] bolus: 400 mg/m\^2, 5-FU infusion: 2400 mg/m\^2) once every 2 weeks, or up to 8 CAPOX treatments (oxaliplatin: 130 mg/m\^2 once every 3 weeks, capecitabine: 1000 mg/m\^2 twice daily on Days 1 through 14 and 22 through 35 of each cycle). Each cycle is approximately 42 days. Treatment will continue at the investigator's discretion until the participant meets study intervention discontinuation criteria.

Drug: Zolbetuximab; Drug: Oxaliplatin; Drug: Folinic Acid; Drug: 5-fluorouracil; Drug: Capecitabine

Interventions

Zolbetuximab DRUG

Participants will receive an IV infusion of zolbetuximab once every 2 or 3 weeks.

Also known as: Vyloy, IMAB362

Zolbetuximab Plus mFOLFOX6 or CAPOX

Oxaliplatin DRUG

Participants receiving mFOLFOX6 or CAPOX regimen of chemotherapy will receive an IV infusion of oxaliplatin once every 2 or 3 weeks.

Zolbetuximab Plus mFOLFOX6 or CAPOX

Folinic Acid DRUG

Participants receiving mFOLFOX6 regimen of chemotherapy will receive an IV infusion of folinic acid once every 2 weeks.

Also known as: Leucovorin

Zolbetuximab Plus mFOLFOX6 or CAPOX

5-fluorouracil DRUG

Participants receiving mFOLFOX6 regimen of chemotherapy will receive an IV infusion or IV bolus of 5-FU once every 2 weeks.

Zolbetuximab Plus mFOLFOX6 or CAPOX

Capecitabine DRUG

Participants receiving CAPOX regimen of chemotherapy will receive an oral capecitabine tablet twice daily on Days 1 through 14 and Days 22 through 35 of each cycle.

Zolbetuximab Plus mFOLFOX6 or CAPOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has histologically confirmed gastric or GEJ adenocarcinoma.
• Participant has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to enrollment.
• Participant has radiologically evaluable disease (measurable and/or non measurable) according to RECIST 1.1, per investigator assessment, ≤ 28 days prior to enrollment. For participants with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before enrollment, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.
• Participant has ECOG performance status 0 or 1.
• Participant has predicted life expectancy ≥ 12 weeks.
• Female participant is not pregnant and at least 1 of the following conditions apply:
• Not a woman of childbearing potential (WOCBP).
• WOCBP who has a negative urine or serum pregnancy test at screening and agrees to follow the contraceptive guidance from the time of informed consent through 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study interventions.
• Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 9 months after the final administration of oxaliplatin and for 6 months after final administration of all other study interventions.
• Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period, and for 9 months after the final administration of oxaliplatin and for 6 months after final administration of all other study interventions.
• Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 6 months after final investigational study intervention administration.
• Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after final investigational study intervention administration.
• Male participant must not donate sperm during the treatment period and for 6 months after final investigational study intervention administration.
• The participant or legally authorized representative has provided informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and protocol.
• Participant's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by local immunohistochemistry testing.

You may not qualify if:

• Participant has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, mFOLFOX6 or CAPOX.
• Participant has known dihydropyrimidine dehydrogenase (DPD) deficiency. (NOTE: Screening for DPD deficiency should be conducted per local requirements.)
• Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.
• Participant has significant gastric bleeding and/or untreated gastric ulcers that exclude the participant from participation.
• Participant has a known history of a positive test for human immunodeficiency virus infection or known active hepatitis B (positive hepatitis B surface antigen \[HBsAg\]) or C infection. (Note: Screening for these infections should be conducted per local requirements.)
• For participants who are negative for HBsAg, but hepatitis B core antibody positive, an hepatitis B virus DNA test will be performed, and if positive, the participant will be excluded.
• Participants with positive hepatitis C virus (HCV) serology but negative HCV RNA test are eligible.
• Participants treated for HCV with undetectable viral load results are eligible.
• Participant has an active autoimmune disease that has required systemic treatment within the past 3 months prior to enrollment.
• Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to enrollment.
• Participant has significant cardiovascular disease, including any of the following:
• Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident, or hypertensive crisis within 6 months prior to enrollment;
• History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes);
• QT corrected (QTc) interval \> 450 msec for male participants; QTc interval \> 470 msec for female participants;
• History or family history of congenital long QT syndrome;

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

MeSH Terms

Conditions

Adenocarcinoma; Neoplasms; Stomach Neoplasms

Interventions

zolbetuximab; Oxaliplatin; Leucovorin; Fluorouracil; Capecitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Medical Monitor

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Central Study Contacts

Astellas Pharma Global Development Inc.

CONTACT

800-888-7704; astellas.registration@astellas.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: September 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.