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NCT03653507 · ClinicalTrials.gov registry record · Phase 3
A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW).
A Phase 3 study of Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer and Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, sponsored by Astellas Pharma Global Development.
- Active
- Registry status
- Phase 3
- Development phase
- 507
- Enrollment target
- 20
- Study locations
NCT03653507 is a Phase 3 study of Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer and Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer that is active but no longer recruiting, run by Astellas Pharma Global Development. The registered enrollment target is 507 participants. The trial reports 20 study locations across 10 states.
The verdict
NCT03653507, a Phase 3 study of Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer and Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, is active but no longer recruiting, sponsored by Astellas Pharma Global Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 507 participants
- Enrollment target
- 20
- Study locations
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 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 stomach 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 people taking part in those countries will leave this study and receive licensed zolbetuximab. The main aim(s) of the study is(are) to determine the efficacy of zolbetuximab combined with chemotherapy compared to a placebo combined with chemotherapy in treating adults with Claudin 18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. 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 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 trea
Conditions Studied
Interventions
- DRUG placebo
- DRUG oxaliplatin
- DRUG zolbetuximab
- DRUG capecitabine
Study Locations (20)
Other
- Site AR54009 - Buenos Aires
- Site GB44005 - Northwood
- Site AR54006 - Pergamino
- Site AR54001 - San Miguel de Tucumán
- Site AR54004 - San Miguel de Tucumán
- Site AR54003 - Viedma
- Site CA15004 - Calgary
Texas
- Parkland Hospital - Dallas
- University of Texas Southwestern Medical Center - Dallas
- Houston Methodist Cancer Center and Institute of Academic Medicine - Oncology - Houston
New York
- Weill Cornell Medical College (WCMC) - New York
- Montefiore Medical Center (MMC) - The Bronx
Quebec
- Site CA15003 - Chicoutimi
- Site CA15002 - Rimouski
California
- Pacific Cancer Care - Monterey
Kansas
- University of Kansas Cancer Center and Medical Pavilion - Fairway
Louisiana
- Ochsner Clinic CCOP - New Orleans
New Mexico
- New Mexico Oncology Hematology - Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 507 participants |
| Start Date | 2018-11-28 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03653507
The ClinicalTrials.gov registry entry for NCT03653507 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 507 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 168 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer appearing as the primary indexed condition, and to 4 interventions - of which placebo is the first listed.
NCT03653507 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, Texas, New York.
Frequently Asked Questions
What is clinical trial NCT03653507 about?
NCT03653507 is a clinical study titled "A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW).". Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called 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 1...
What is the current status of trial NCT03653507?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 507 participants. The study started on 2018-11-28. Estimated completion is 2026-09-30.
What conditions does trial NCT03653507 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.
What interventions are being tested in trial NCT03653507?
The interventions under investigation include: placebo (DRUG), oxaliplatin (DRUG), zolbetuximab (DRUG), capecitabine (DRUG).
Who is sponsoring clinical trial NCT03653507?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03653507 being conducted?
This trial has 20 study locations across California, Kansas, Louisiana, New Mexico, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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