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NCT Number: NCT06902545

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

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).

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Key information

Conditions

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer Adenocarcinoma Carcinoma Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer Metastatic Gastric Adenocarcinoma or Cancer Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Sex eligibility

All sexes

Study type

Observational

Primary location

KR82010, Goyang-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

zolbetuximab

Drug

Intravenous

Other names: Vyloy

Primary outcomes

  1. Number of patients with an adverse event (AE)

    Time frame: Up to 54 Weeks after the first administration of VYLOY

    Adverse events (AEs) will be coded using MedDRA. An AE is defined as any untoward medical occurrence in a patient administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.

  2. Number of patients with an adverse drug reaction (ADR)

    Time frame: Up to 54 Weeks after the first administration of VYLOY

    An ADR is defined as any noxious and unintended response associated with the use of a drug in humans, at any dose, where a causal relationship is at least a reasonable possibility.

  3. Number of patients with a serious AE (SAE)

    Time frame: Up to 54 Weeks after the first administration of VYLOY

    An AE is considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, requires hospitalization or prolongation to hospitalization results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect, or other medically important event.

  4. Number of patients with a serious ADR (SADR)

    Time frame: Up to 54 Weeks after the first administration of VYLOY

    An ADR considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, requires hospitalization or prolongation to hospitalization results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect, or other medically important event.

  5. Number of patients with an unexpected AE (UAE)

    Time frame: Up to 54 Weeks after the first administration of VYLOY

    An UAE is an AE that the nature or severity of which is not consistent with the information in the Precautions in Use Section of approved Korean label.

  6. Number of patients with an unexpected ADR (UADR)

    Time frame: Up to 54 Weeks after the first administration of VYLOY

    An UADR is defined as an unexpected adverse drug reaction.

  7. Number of patients who died during the study

    Time frame: Up to 54 Weeks after the first administration of VYLOY

  8. Number patients with an AE leading to death

    Time frame: Up to 54 Weeks after the first administration of VYLOY

  9. Number of patients with an important risk compared to number of patients evaluated

    Time frame: Up to 54 Weeks after the first administration of VYLOY

    An important risk is classified as an important identified risk and an important potential risk.

    An identified risk is defined as the risk that correspond to undesirable clinical outcomes, with sufficient scientific evidence that the undesirable clinical outcome is caused by the drug. "Important Identified Risks" are identified risks that have the potential to affect the risk-benefit balance of a product.

    An potential risk is defined as the risk that correspond to undesirable clinical outcomes, with some, but not sufficient, evidence to estimate that the undesirable clinical outcome is caused by the drug. "Important Potential Risks" are potential risks that have the potential to affect the risk-benefit balance of a product.

Secondary outcomes

  1. Progression free survival (PFS)

    Time frame: Up to 54 Weeks after the first administration of VYLOY

    PFS is defined as time from start of VYLOY to progressive disease (PD) or death from any cause, whichever occurs first.

Study contacts

Contact information is provided by the study sponsor or research team.

Astellas Pharma Global Development, Inc.

CONTACT

[email protected]

800-888-7704

Sponsors and collaborators

Lead sponsor

Astellas Pharma Korea, Inc.

Industry

Registry information

Official study title

Post-marketing Observational Study of VYLOY (Zolbetuximab) Injection 100 mg, 300 mg for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in South Korea

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Mar 30, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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