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New study tracks safety of VYLOY in everyday cancer care

NCT ID NCT06902545

Disease control Sponsor: Astellas Pharma Korea, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times

Summary

This study monitors 377 South Korean patients with advanced stomach or gastroesophageal junction cancer who receive VYLOY (zolbetuximab) as part of their normal treatment. Researchers will track side effects and how long the cancer stays stable. The goal is to confirm the drug's safety in real-world use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zolbetuximab (VYLOY)
What this could lead to
If successful, this study will confirm the safety of VYLOY in everyday use, supporting its continued approval for advanced gastric and GEJ cancer.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove effectiveness. Side effects may still occur, and results may not apply outside South Korea.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 377 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who have locally advanced unresectable or metastatic HER2-negative, and CLDN18.2-positive, gastric or GEJ adenocarcinoma who are prescribed VYLOY injection in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first line treatment in South Korea.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Get notified about this study

Sign up to get updates when this study changes or when new studies for Locally advanced unresectable gastric adenocarcinoma or cancer are added.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma gastric adenocarcinoma gastric cancer gastroesophageal junction adenocarcinoma neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced unresectable gastric adenocarcinoma or cancer Locally advanced unresectable gastroesophageal junction (GEJ) adenocarcinoma or cancer Metastatic gastric adenocarcinoma or cancer Metastatic gastroesophageal junction (GEJ) adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • KR82001

    RECRUITING

    Seoul, South Korea

  • KR82002

    RECRUITING

    Seoul, South Korea

  • KR82003

    RECRUITING

    Seoul, South Korea

  • KR82004

    RECRUITING

    Seoul, South Korea

  • KR82005

    RECRUITING

    Seoul, South Korea

  • KR82006

    RECRUITING

    Yangsan, Gyeongsangnam-do, South Korea

  • KR82007

    RECRUITING

    Seoul, South Korea

  • KR82008

    RECRUITING

    Suwon, Gyeonggi-do, South Korea

  • KR82009

    RECRUITING

    Suwon, Gyeonggi-do, South Korea

  • KR82010

    RECRUITING

    Goyang-si, Gyeonggi-do, South Korea

  • KR82011

    RECRUITING

    Seoul, South Korea

  • KR82012

    RECRUITING

    Hwasun Gun, Jeollanam-do, South Korea

  • KR82013

    RECRUITING

    Seoul, South Korea

  • KR82015

    RECRUITING

    Daejeon, South Korea

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