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A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer
NCT06901531 · 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. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). 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. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults with stomach cancer or GEJ cancer will either be given zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it. The main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy. Adults with locally advanced unresectable or metastatic 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 (biopsy) of their cancer will have the Claudin 18.2 protein, PD-L1 protein, and be HER2-negative. They may have been previously treated with certain standard therapies. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as sympt
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Capecitabine
- DRUG Oxaliplatin
- DRUG zolbetuximab
- DRUG Folinic acid (leucovorin or local equivalent)
Study Locations (20)
Michigan
- University of Michigan Health System — Ann Arbor
- Barbara Ann Karmanos Cancer Center — Detroit
- Henry Ford Cancer Institute-Henry Ford Hospital — Detroit
Connecticut
- Hartford HealthCare - Hartford Hospital — Hartford
- Yale University School of Medicine — New Haven
Nebraska
- University of Nebraska Medical Center — Omaha
- Oncology Hematology West PC dba Nebraska Cancer Specialists — Omaha
New York
- NYU Langone Medical Center — New York
- Montefiore Medical Center — The Bronx
North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill
- Duke University Medical Center - Duke Cancer Centre — Durham
California
- TOI Clinical Research — Cerritos
Indiana
- Franciscan Health Oncology and Hematology Specialists — Indianapolis
Iowa
- Holden Comprehensive Cancer Center — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2025-05-22 |
| Est. Completion | 2028-09-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06901531
The ClinicalTrials.gov registry entry for NCT06901531 describes a study currently listed as 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 500 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 Pembrolizumab 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: NCT06901531 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Michigan, Connecticut, Nebraska. 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 NCT06901531 about?
NCT06901531 is a clinical study titled "A Study of Zolbetuximab Together With Pembrolizumab 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. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein ca...
What is the current status of trial NCT06901531?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2025-05-22. Estimated completion is 2028-09-30.
What conditions does trial NCT06901531 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 NCT06901531?
The interventions under investigation include: Pembrolizumab (DRUG), Capecitabine (DRUG), Oxaliplatin (DRUG), zolbetuximab (DRUG), Folinic acid (leucovorin or local equivalent) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06901531?
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 NCT06901531 being conducted?
This trial has 20 study locations across California, Connecticut, Indiana, Iowa, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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