RecruitingNCT06902545

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

Post-marketing Observational Study of VYLOY (Zolbetuximab) Injection 100 mg for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in South Korea


Sponsor

Astellas Pharma Korea, Inc.

Enrollment

377 participants

Start Date

Apr 3, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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).


Eligibility

Plain Language Summary

Simplified for easier understanding

This is an observational safety monitoring study for VYLOY (zolbetuximab), a cancer medication that has been approved in South Korea for treating stomach (gastric) or gastroesophageal junction (GEJ) cancer. Researchers are collecting real-world safety data as the drug is used in routine clinical practice. **You may be eligible if...** - You are receiving VYLOY (zolbetuximab) as part of your approved treatment plan for gastric or GEJ cancer in South Korea **You may NOT be eligible if...** - You have any condition that is a contraindication to VYLOY according to its approved label - You are already enrolled in, or plan to enroll in, another clinical trial with an investigational drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGzolbetuximab

Intravenous


Locations(13)

KR82010

Goyang-si, Gyeonggi-do, South Korea

KR82008

Suwon, Gyeonggi-do, South Korea

KR82009

Suwon, Gyeonggi-do, South Korea

KR82006

Yangsan, Gyeongsangnam-do, South Korea

KR82012

Hwasun Gun, Jeollanam-do, South Korea

KR82001

Seoul, South Korea

KR82002

Seoul, South Korea

KR82003

Seoul, South Korea

KR82004

Seoul, South Korea

KR82005

Seoul, South Korea

KR82007

Seoul, South Korea

KR82011

Seoul, South Korea

KR82013

Seoul, South Korea

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NCT06902545


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