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NCT03505320 · ClinicalTrials.gov registry record · Phase 2

A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer

A Phase 2 study of Gastric Cancer and Pharmacokinetics of Zolbetuximab, sponsored by Astellas Pharma Global Development.

Active
Registry status
Phase 2
Development phase
143
Enrollment target
20
Study locations

NCT03505320 is a Phase 2 study of Gastric Cancer and Pharmacokinetics of Zolbetuximab that is active but no longer recruiting, run by Astellas Pharma Global Development. The registered enrollment target is 143 participants, below the 318-participant average among 153 other Gastric Cancer trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 6 states.

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The verdict

NCT03505320, a Phase 2 study of Gastric Cancer and Pharmacokinetics of Zolbetuximab, is active but no longer recruiting, sponsored by Astellas Pharma Global Development.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
143 participants
Enrollment target
20
Study locations

Study Summary

Zolbetuximab is being studied as a treatment for people with cancer in and around the stomach or cancer where the food pipe (esophagus) joins the stomach (gastroesophageal junction 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 Claudin 18.2 in their tumor. This switches on the body's immune system to attack the tumor. There is an unmet medical need to treat people with advanced cancer in and around the stomach or gastroesophageal junction cancer. This study will provide more information on zolbetuximab given by itself and in combination with other treatments in adults with advanced stomach or gastroesophageal junction cancer. The study is currently ongoing globally. People in this study will either be treated with zolbetuximab by itself, with zolbetuximab and chemotherapy, with zolbetuximab and a medicine called pembrolizumab, or zolbetuximab with chemotherapy and a medicine called nivolumab. This study is ongoing, but enrollment in any of the treatment options has been completed. In addition, at this stage of the study, treatment in some of these treatment options has completed. The main aim of this study is to check how well zolbetuximab controls tumors when given by itself. Adults with cancer in and around the stomach or gastroesophageal junction cancer can take part. Their cancer is locally advanced unresectable or metastatic and has the CLDN18.2 marker in a tumor sample. 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. They may have been previously treated with 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 symptomatic or untreated cancers in the nervous system, have a specific

Conditions Studied

Gastric Cancer Pharmacokinetics of Zolbetuximab Gastro-esophageal Junction (GEJ) Cancer Pharmacokinetics of Oxaliplatin Pharmacokinetics of Fluorouracil Bolus (5-FU)

Interventions

  • DRUG Pembrolizumab
  • DRUG oxaliplatin
  • DRUG fluorouracil
  • DRUG leucovorin
  • DRUG zolbetuximab

Study Locations (20)

Other

  • Site FR33001 - Brest
  • Site FR33004 - Paris
  • Site IT39005 - Milan
  • Site IT39002 - Naples
  • Site IT39004 - Padua
  • Site IT39003 - Pisa
  • Site JP81001 - Chiba
  • Site JP81002 - Tokyo
  • Site JP81003 - Tokyo
  • Site KR82002 - Seongnam-si
  • Site KR82001 - Seoul
  • Site TW88601 - Taichung

California

  • The Angeles Clinic and Research Institute - Los Angeles
  • UCLA Medical Center - Santa Monica

New York

  • Memorial Sloan Kettering Cancer Center - New York
  • Weill Cornell Medical College - New York

Nouvelle-Aquitaine

  • Site FR33003 - Pessac
  • Site FR33002 - Poitiers

Illinois

  • University of Chicago - Chicago

Massachusetts

  • Mass General / North Shore Can - Boston

Trial Details

FieldValue
Enrollment Target 143 participants
Start Date 2018-06-29
Est. Completion 2027-05-31
Phase Phase 2

Sponsor

Astellas Pharma Global Development

168 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03505320

The ClinicalTrials.gov registry entry for NCT03505320 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 318-participant average among 153 other Gastric Cancer trials with a reported enrollment target (55% lower). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT03505320 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Other, California, New York.

Frequently Asked Questions

What is clinical trial NCT03505320 about?

NCT03505320 is a clinical study titled "A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer". Zolbetuximab is being studied as a treatment for people with cancer in and around the stomach or cancer where the food pipe (esophagus) joins the stomach (gastroesophageal junction cancer). Most people with this type of cancer have a protein called Claudin 18.2 in their tumor. Zolbetuximab is though...

What is the current status of trial NCT03505320?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 143 participants. The study started on 2018-06-29. Estimated completion is 2027-05-31.

What conditions does trial NCT03505320 study?

This clinical trial studies the following conditions: Gastric Cancer, Pharmacokinetics of Zolbetuximab, Gastro-esophageal Junction (GEJ) Cancer, Pharmacokinetics of Oxaliplatin, Pharmacokinetics of Fluorouracil Bolus (5-FU).

What interventions are being tested in trial NCT03505320?

The interventions under investigation include: Pembrolizumab (DRUG), oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin (DRUG), zolbetuximab (DRUG).

Who is sponsoring clinical trial NCT03505320?

This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03505320 being conducted?

This trial has 20 study locations across California, Illinois, Massachusetts, New York, Nouvelle-Aquitaine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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