Zolbetuximab Claudin18.2 Positive, HER2 Negative, Advanced Gastric Cancer

Launched by YONSEI UNIVERSITY · Jan 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a treatment called Zolbetuximab for patients with advanced gastric cancer that tests positive for a specific marker called Claudin18.2. The trial aims to understand how well this treatment works in real-world situations and to monitor any side effects it may cause. To participate, patients must be at least 19 years old, have a confirmed diagnosis of advanced gastric or gastroesophageal junction cancer, and their tumors must show a significant presence of Claudin18.2 while being negative for another marker called HER2.

Participants in the trial will receive Zolbetuximab as their first treatment and will have tissue and blood samples collected to help researchers learn more about the cancer and the treatment's effects. It's important to note that patients who have previously participated in other trials involving Zolbetuximab or certain other treatments may not be eligible. If you're interested or think you might qualify, you should talk to your doctor for more information about this opportunity.

Gender

ALL

Eligibility 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.