Clinical trial NCT06902545: A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer.
Official title: Post-marketing Observational Study of VYLOY (Zolbetuximab) Injection 100 mg for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in South Korea
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
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
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2025-03-30
Enrollment: 377
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with an adverse event (AE)
timeFrame: Up to 54 Weeks after the first administration of VYLOY
measure: Number of patients with an adverse drug reaction (ADR)
timeFrame: Up to 54 Weeks after the first administration of VYLOY
measure: Number of patients with a serious AE (SAE)
timeFrame: Up to 54 Weeks after the first administration of VYLOY
measure: Number of patients with a serious ADR (SADR)
timeFrame: Up to 54 Weeks after the first administration of VYLOY
measure: Number of patients with an unexpected AE (UAE)
timeFrame: Up to 54 Weeks after the first administration of VYLOY
measure: Number of patients with an unexpected ADR (UADR)
timeFrame: Up to 54 Weeks after the first administration of VYLOY
measure: Number of patients who died during the study
timeFrame: Up to 54 Weeks after the first administration of VYLOY
measure: Number patients with an AE leading to death
timeFrame: Up to 54 Weeks after the first administration of VYLOY
measure: Number of patients with an important risk compared to number of patients evaluated
timeFrame: Up to 54 Weeks after the first administration of VYLOY
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: Up to 54 Weeks after the first administration of VYLOY
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: KR82001
Study officials:
affiliation: Astellas Pharma Korea, Inc.
name: Central Contact
role: STUDY_DIRECTOR
References: