Clinical trial · Observational
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, 300 mg for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in South Korea
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer | — | UNRESOLVED | — |
| Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer | — | UNRESOLVED | — |
| Metastatic Gastric Adenocarcinoma or Cancer | — | UNRESOLVED | — |
| Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| zolbetuximab | Drug | Zolbetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Vyloy
- description
- Patients who receive treatment with Vyloy injection 100 mg or 300 mg (zolbetuximab), according to the approved local label.
- interventionNames
- Drug: zolbetuximab
Primary outcomes (9)
- measure
- Number of patients with an adverse event (AE)
- timeFrame
- Up to 54 Weeks after the first administration of VYLOY
- description
- 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.
- measure
- Number of patients with an adverse drug reaction (ADR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available