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A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer.

NCT ID: NCT06902545

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

377 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-03

Study Completion Date

2030-07-31

Brief Summary

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This study is for people in South Korea who have cancer in or around the stomach (gastric cancer) or cancer where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Their cancer is locally advanced, unresectable, or metastatic. Locally advanced means the cancer has spread to tissue close by. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body.

In South Korea, VYLOY is approved for the treatment of gastric cancer or GEJ cancer. The people in this study will receive VYLOY as part of their usual treatment for their cancer. In standard clinical practice VYLOY is given to people slowly through a tube into a vein.

The main aim of the study is to collect information in a real-world setting about the safety of VYLOY in people with gastric cancer or GEJ cancer in clinics in South Korea. This study will also help researchers learn how long people's gastric cancer or GEJ cancer stays stable.

This study is about collecting information only. This is known as an observational study. The individual's doctor decides on treatment, not the sponsor (Astellas). The study will last about 1 year (54 weeks).

Detailed Description

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Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vyloy

Patients who receive treatment with Vyloy injection 100 mg (zolbetuximab), according to the approved local label.

zolbetuximab

Intervention Type DRUG

Intravenous

Interventions

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zolbetuximab

Intravenous

Intervention Type DRUG

Other Intervention Names

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Vyloy

Eligibility Criteria

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Inclusion Criteria

* Patients who receive treatment with VYLOY injection, according to the approved local label.

Exclusion Criteria

* Patients with any contraindication for VYLOY injection, according to the approved local label.
* Patients who are registered or scheduled to be registered in any clinical trials involving investigational drug administration.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Korea, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Korea, Inc.

Locations

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KR82010

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

KR82008

Suwon, Gyeonggi-do, South Korea

Site Status RECRUITING

KR82006

Yangsan, Gyeongsangnam-do, South Korea

Site Status RECRUITING

KR82012

Hwasun Gun, Jeollanam-do, South Korea

Site Status RECRUITING

KR82001

Seoul, , South Korea

Site Status RECRUITING

KR82002

Seoul, , South Korea

Site Status RECRUITING

KR82003

Seoul, , South Korea

Site Status RECRUITING

KR82004

Seoul, , South Korea

Site Status RECRUITING

KR82005

Seoul, , South Korea

Site Status RECRUITING

KR82007

Seoul, , South Korea

Site Status RECRUITING

KR82011

Seoul, , South Korea

Site Status RECRUITING

KR82013

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Astellas Pharma Global Development, Inc.

Role: CONTACT

[email protected]
800-888-7704

Other Identifiers

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8951-PV-0001

Identifier Type: -

Identifier Source: org_study_id