Evaluating Zolbetuximab in Advanced Gastric Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the real-world effectiveness of Zolbetuximab in patients with advanced gastric cancer who have a specific tumor profile. It will evaluate treatment outcomes such as progression-free survival, overall survival, and response rates, while also monitoring adverse effects using standardized criteria. Tissue and blood samples will be collected at various stages to analyze biomarkers and their correlation with treatment response, including PD-L1 expression and ctDNA profiling.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient is ≥ 19 years of age at the time of consent.
2. The patient must have histologically confirmed locally advanced, unresectable, or metastatic gastric or gastroesophageal junction adenocarcinoma
3. Patient whose tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining as determined by local or central IHC testing.
4. The tumor sample must be HER2-negative (IHC 0, 1+, or IHC 2+/ISH-).
5. The patient must have received Zolbetuximab as a first-line treatment.
6. 1 Patient has ECOG performance status 0 or 1.
7. Patient must meet all of the following criteria based on the locally analyzed laboratory tests collected.

   * Hb ≥8 g/dL (For patients who require a transfusion, it is appropriate if Hb ≥9 g/dL after transfusion)
   * ANC ≥1.0 x 10\^9/L
   * Platelet ≥75 x 10\^9/L
   * Total bilirubin ≤1.5 x ULN without liver metastasis, or \<3.0 x ULN if liver metastasis is present
   * AST or ALT ≤2.5 x ULN without liver metastasis, or ≤5 x ULN if liver metastasis is present
   * Estimated creatinine clearance ≥30 mL/min

Exclusion Criteria:

1. Patient has previously received treatment in a clinical trial of zolbetuximab, or a clinical trial that included zolbetuximab as 1 of the treatment options, even if the patient was not given zolbetuximab
2. History of known or suspected hypersensitivity to Zolbetuximab, other monoclonal antibodies, or components of the used formulations.
3. Patient has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, patient may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as it was completed at least 6 months prior to participation.
4. Patients who have received systemic immunosuppressive therapy, including systemic corticosteroids, within 14 days before enrollment. However, patients using physiological replacement doses of hydrocortisone or its equivalent (maximum hydrocortisone 30 mg/day or prednisone 10 mg/day), those who have received a single dose of systemic corticosteroid, or those who have received systemic corticosteroids as premedication for radiologic contrast agents are allowed.
5. Patient has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting
6. Per investigator judgment, patient has significant gastric bleeding and/or untreated gastric ulcers that would exclude the patient from participation per investigator Judgment
7. Patient has any other condition, which, in the opinion of the treating physician, makes the patient unsuitable to receive or tolerate zolbetuximab.

Where it's running

• Severance Hospital
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Sun Young Rha — Severance Hospital
• Study coordinator: Sun Young Rha
• Email: Rha7655@yuhs.ac
• Phone: 82-2-2227-8406

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Zolbetuximab added to FLOT and durvalumab before surgery for CLDN18.2-positive gastric/GEJ cancer

  This study tests whether adding zolbetuximab to FLOT chemotherapy plus durvalumab can improve tumor response before surgery in adults with CLDN18.2-positive gastric or GEJ cancer.

  Recruiting Phase 2 National Cancer Center, Japan · Saitama and 3 other locations · NCT07872722

• Predicting Immunotherapy Response in Advanced Gastric Cancer using PET Imaging

  This study tests whether FAPI PET/CT and Grazytracer PET/CT can predict how advanced gastric cancer will respond to preoperative immunotherapy-based treatment.

  Recruiting Ruijin Hospital · Shanghai · NCT07824479

• Adding 2141-V11 to standard therapy for advanced esophageal, gastric, or gastroesophageal junction cancer

  This study tests whether adding the drug 2141-V11 to standard anti-PD-1 therapy (with or without 5-FU) is safe for adults with advanced or metastatic esophageal, gastric, or gastroesophageal junction adenocarcinoma.

  Recruiting at 7 sites Phase 1/2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07818018

• Low-leucine diet with chemotherapy and immunotherapy for advanced stomach cancer

  This will test whether a low-leucine diet helps people with advanced gastric cancer respond better to combined chemotherapy and immunotherapy.

  Recruiting Phase 2 Qilu Hospital of Shandong University · Jinan, Shandong · NCT07537348

• BHB810 in advanced gastric and GEJ cancer (early-phase)

  This study tests whether BHB810 can be safely given every two weeks to adults with advanced gastric or GEJ adenocarcinoma and looks at its effect, how the drug behaves in the body, and patient responses.

  Recruiting at 2 sites Phase 1/2 BigHat Biosciences, Inc. · Duarte, California and 2 other locations · NCT07529808

• Zolbetuximab with chemotherapy for HER2-negative, Claudin 18.2–positive metastatic gastric or gastroesophageal junction adenocarcinoma

  This project will try zolbetuximab together with FOLFOX or XELOX as first-line treatment for adults whose HER2-negative stomach or gastroesophageal junction cancers strongly express Claudin 18.2.

  Recruiting European Institute of Oncology · Milan · NCT07427992

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.