Evaluating Zolbetuximab in Advanced Gastric Cancer
Multi-center Cohort Study to Evaluate the Real-world Efficacy and Safety of Zolbetuximab Plus Chemotherapy in Claudin18.2 Positive, HER2 Negative, Advanced Gastric Cancer
This study is testing if a new drug called Zolbetuximab can help people with advanced gastric cancer who have a certain type of tumor, by looking at how well it works and what side effects it might cause.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Drugs / interventions | Zolbetuximab, chemotherapy, immunotherapy, prednisone |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06767449 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with histologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma that expresses CLDN18.2 and is HER2-negative.
Not a fit: Patients whose tumors do not express CLDN18.2 or are HER2-positive may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Zolbetuximab for patients with advanced gastric cancer, potentially leading to improved treatment strategies.
How similar studies have performed: While there have been studies on similar treatments, this specific approach focusing on Zolbetuximab in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.