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

NCT06902545 | Recruiting

• 1 other identifier: 8951-PV-0001
• Study Type: observational
• Target: 377
• Locations: 1 country
• Sites: 13

Brief 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).

Conditions

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

Keywords

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer; Locally Advanced Unresectable Gastric Adenocarcinoma Cancer; Metastatic Gastric Adenocarcinoma Cancer; Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma; Claudin 18.2; Human epidermal growth factor receptor 2 (HER2) Negative; zolbetuximab; Pharmcovigilence

Outcome Measures

Primary Outcomes (9)

• Number of patients with an adverse event (AE)

  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.

  Up to 54 Weeks after the first administration of VYLOY

• Number of patients with an adverse drug reaction (ADR)

  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.

  Up to 54 Weeks after the first administration of VYLOY

• Number of patients with a serious AE (SAE)

  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.

  Up to 54 Weeks after the first administration of VYLOY

• Number of patients with a serious ADR (SADR)

  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.

  Up to 54 Weeks after the first administration of VYLOY

• Number of patients with an unexpected AE (UAE)

  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.

  Up to 54 Weeks after the first administration of VYLOY

• Number of patients with an unexpected ADR (UADR)

  An UADR is defined as an unexpected adverse drug reaction.

  Up to 54 Weeks after the first administration of VYLOY

• Number of patients who died during the study

  Up to 54 Weeks after the first administration of VYLOY

• Number patients with an AE leading to death

  Up to 54 Weeks after the first administration of VYLOY

• Number of patients with an important risk compared to number of patients evaluated

  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.

  Up to 54 Weeks after the first administration of VYLOY

Secondary Outcomes (1)

• Progression free survival (PFS)

  Up to 54 Weeks after the first administration of VYLOY

Study Arms (1)

Vyloy

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

Drug: zolbetuximab

Interventions

zolbetuximab DRUG

Intravenous

Also known as: Vyloy

Vyloy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients who receive treatment with VYLOY injection, according to the approved local label.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Korea, Inc.: lead

Study Sites (13)

KR82010

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

KR82008

Suwon, Gyeonggi-do, South Korea

RECRUITING

KR82009

Suwon, Gyeonggi-do, South Korea

RECRUITING

KR82006

Yangsan, Gyeongsangnam-do, South Korea

RECRUITING

KR82012

Hwasun Gun, Jeollanam-do, South Korea

RECRUITING

KR82001

Seoul, South Korea

RECRUITING

KR82002

Seoul, South Korea

RECRUITING

KR82003

Seoul, South Korea

RECRUITING

KR82004

Seoul, South Korea

RECRUITING

KR82005

Seoul, South Korea

RECRUITING

KR82007

Seoul, South Korea

RECRUITING

KR82011

Seoul, South Korea

RECRUITING

KR82013

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma; Neoplasms

Interventions

zolbetuximab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Central Contact

  Astellas Pharma Korea, Inc.

  STUDY DIRECTOR

Central Study Contacts

Astellas Pharma Global Development, Inc.

CONTACT

800-888-7704; astellas.registration@astellas.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: April 3, 2025
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (13)