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ACTIVE NOT RECRUITING 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).

NCT03653507 · 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 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

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

FieldValue
Enrollment Target 507 participants
Start Date 2018-11-28
Est. Completion 2026-09-30
Phase Phase 3

Sponsor

Astellas Pharma Global Development

172 total trials

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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. 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 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 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 4 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: NCT03653507 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, Texas, New York. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03653507?

The interventions under investigation include: placebo (DRUG), oxaliplatin (DRUG), zolbetuximab (DRUG), capecitabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03653507?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial