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A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
NCT03504397 · View on ClinicalTrials.gov ↗
Study Summary
Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Most people with this type of cancer have a protein called Claudin 18.2 in their tumor. Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. There is an unmet medical need to treat people with advanced stomach cancer or GEJ cancer. This study will give more information about how well zolbetuximab works when given with chemotherapy in adults with advanced stomach cancer or GEJ cancer. In this study, adults with advanced stomach cancer or GEJ cancer will either be given zolbetuximab with chemotherapy or a placebo with chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it. Zolbetuximab with chemotherapy has already been approved to treat gastric cancer and GEJ cancer in some countries. This study is being done in countries where zolbetuximab has not yet been approved for use. If zolbetuximab becomes approved for use in those countries taking part in this study, the study doctor will switch study treatment in those countries to the licensed zolbetuximab. If this happens, people taking part in those countries will leave this study and receive licensed zolbetuximab. The main aim of the study is to check if zolbetuximab and chemotherapy can prevent or delay the worsening of people's gastric cancer and GEJ cancer compared to placebo and chemotherapy. Adults with advanced stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample of their cancer will also have the Claudin 18.2 protein. They may have been previously treated with certain standard therapies, but have not been treated wi
Conditions Studied
Interventions
- DRUG placebo
- DRUG oxaliplatin
- DRUG fluorouracil
- DRUG zolbetuximab
- DRUG folinic acid
Study Locations (20)
California
- CBCC Global Research, Inc. at Comprehensive Blood and Cancer — Bakersfield
- City of Hope Nat'l Medical Center — Duarte
- St. Jude Hospital Yorba Linda — Fullerton
- Pacific Shores Medical Group — Huntington Beach
- Loma Linda University — Loma Linda
- The Angeles Clinic and Research Institute — Los Angeles
- University of California Davis — Sacramento
- University of California - San Francisco — San Francisco
Florida
- Memorial Cancer Institute - West — Hollywood
- University of Miami — Miami
- Orlando Health Inc — Orlando
- Memorial Hospital West — Pembroke Pines
Arizona
- University of Arizona — Phoenix
- The University of Arizona Medical Center — Tucson
Illinois
- Northwestern University Medical Center — Chicago
- University of Chicago — Chicago
Colorado
- University of Colorado — Aurora
Connecticut
- Memorial Sloan Kettering Cancer Center — Middletown
Georgia
- Cancer Treatment Centers of America, Atlanta — Newnan
Kentucky
- Norton Cancer Institute — Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 565 participants |
| Start Date | 2018-06-21 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03504397
The ClinicalTrials.gov registry entry for NCT03504397 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 565 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 172 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer appearing as the primary indexed condition, and to 5 interventions — of which placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03504397 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03504397 about?
NCT03504397 is a clinical study titled "A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.". Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Most people with this type of cancer have a protein called Claudin 18.2 in their tumor. Zolbetuximab is thought to work b...
What is the current status of trial NCT03504397?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 565 participants. The study started on 2018-06-21. Estimated completion is 2026-09-30.
What conditions does trial NCT03504397 study?
This clinical trial studies the following 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03504397?
The interventions under investigation include: placebo (DRUG), oxaliplatin (DRUG), fluorouracil (DRUG), zolbetuximab (DRUG), folinic acid (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03504397?
This trial is sponsored by Astellas Pharma Global Development, which has 172 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03504397 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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