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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

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.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official 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

Conditions

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

Being tested

zolbetuximab

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

Medical subject headings

Adenocarcinoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• zolbetuximabDrug

  Also called Vyloy

  Intravenous

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: Up to 54 Weeks after the first administration of VYLOY

2. 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.

   Measured: Up to 54 Weeks after the first administration of VYLOY

3. 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.

   Measured: Up to 54 Weeks after the first administration of VYLOY

4. 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.

   Measured: Up to 54 Weeks after the first administration of VYLOY

5. 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.

   Measured: Up to 54 Weeks after the first administration of VYLOY

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

   An UADR is defined as an unexpected adverse drug reaction.

   Measured: Up to 54 Weeks after the first administration of VYLOY

7. Number of patients who died during the study

   Measured: Up to 54 Weeks after the first administration of VYLOY

8. Number patients with an AE leading to death

   Measured: Up to 54 Weeks after the first administration of VYLOY

9. 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.

   Measured: Up to 54 Weeks after the first administration of VYLOY

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted30 Mar 2025
2. Study start3 Apr 2025
3. Primary completion31 Jul 2030 (estimated)
4. Study completion31 Jul 2030 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or CancerStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.