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

Astellas

Status: Enrolling

Conditions: Metastatic Gastric Adenocarcinoma or Cancer; Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer; Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma; Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer

Treatments: Drug: zolbetuximab

Study type: Observational

Funder types: Industry

Identifiers

NCT06902545

8951-PV-0001

Details and patient eligibility

About

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).

Enrollment: 377 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

377 participants in 1 patient group

Vyloy

Description:

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

Treatment:

Drug: zolbetuximab