Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or CancerPhase 4NCT07829757
A Study of Zolbetuximab Given With mFOLFOX6 or CAPOX Chemotherapy in Indian Adults With Gastric Cancer
A Phase 4 study testing Zolbetuximab, Oxaliplatin and Folinic Acid in people with Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer and Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, run by Astellas Pharma Global Development, Inc..
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer
- What is being tested?
- Zolbetuximab, Oxaliplatin and Folinic Acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 31 Jul 2029
- Phase
- Phase 4
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
- 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:
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- 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.
- Participant has a human epidermal growth factor receptor 2 (HER2)-negative tumor as determined by local testing on a gastric or GEJ tumor specimen.
- Participant must meet all of the criteria based on the locally analyzed laboratory tests collected within 14 days prior to enrollment. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility.
- Participant agrees not to participate in another interventional study while receiving study intervention in the present study.
Who cannot join
- 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.
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- 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;
- Cardiac arrhythmias requiring anti-arrhythmic medications (participants with rate controlled arterial fibrillation for > 1 month prior to enrollment are eligible.)
- Participant has history of central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ cancer.
- Participant has known peripheral sensory neuropathy > grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality.
- Participant has had a major surgical procedure ≤ 28 days before enrollment and has not completely recovered from the surgical procedure ≤ 14 days before enrollment.
- Participant has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, participant 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 enrollment.
- Participant has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma ≤ 14 days prior to enrollment and has not recovered from any related toxicity. Palliative radiotherapy is allowed and must be completed > 14 days prior to enrollment.
- Participant has received treatment with herbal medications or other treatments that have known antitumor activity within 28 days prior to enrollment.
- Participant has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to enrollment. Participant using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids, or receiving systemic corticosteroids as premedication for radiologic imaging contrast use is eligible.
- Participant has received any investigational therapy within 28 days prior to enrollment.
- Participant has any condition, which makes the participant unsuitable for study participation.
- Participant has another malignancy for which treatment is required.
- Participant has any concurrent disease, infection, or co-morbid condition that interferes with the ability of the participant to participate in the study, which places the participant at undue risk or complicates the interpretation of data.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 4, Multicenter, Open-label, Safety and Antitumor Activity Study of Zolbetuximab Plus mFOLFOX6 or CAPOX as Firstline Treatment in Indian Participants With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
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 Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
- Being tested
- Zolbetuximab, Oxaliplatin, Folinic Acid, 5-fluorouracil, Capecitabine
- Keywords
- HER2, IMAB362, leucovorin, fluorouracil, Gastric cancer, zolbetuximab, oxaliplatin, adenocarcinoma, Gastroesophageal Junction cancer, HER2 Negative, mFOLFOX6, CAPOX, capecitabine
- Medical subject headings
- Adenocarcinoma, Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZolbetuximabDrug
Also called Vyloy, IMAB362
Participants will receive an IV infusion of zolbetuximab once every 2 or 3 weeks.
OxaliplatinDrug
Participants receiving mFOLFOX6 or CAPOX regimen of chemotherapy will receive an IV infusion of oxaliplatin once every 2 or 3 weeks.
Folinic AcidDrug
Also called Leucovorin
Participants receiving mFOLFOX6 regimen of chemotherapy will receive an IV infusion of folinic acid once every 2 weeks.
5-fluorouracilDrug
Participants receiving mFOLFOX6 regimen of chemotherapy will receive an IV infusion or IV bolus of 5-FU once every 2 weeks.
CapecitabineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Zolbetuximab; Drug: Oxaliplatin; Drug: Folinic Acid; Drug: 5-fluorouracil; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 32 months
Number of participants with laboratory assessments abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Measured: Up to 32 months
Number of participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Measured: 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.
Measured: Up to 29 months
Secondary outcomes (2)
Objective response rate (ORR)
Defined as the percentage of participants who have a best overall response (BOR) of complete response (CR) or partial response (PR) as investigator assessed per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1).
Measured: Up to 29 months
Duration of response (DOR)
Defined as the time from the date of the first response (CR/PR) until the date of progressive disease (PD) as investigator assessed per RECIST 1.1 or date of death, whichever is earlier.
Measured: Up to 29 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or CancerStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829757
- Sponsor's protocol ID
- 8951-CL-4001
- Status last verified
- Aug 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.