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

Plain-language summary

This study looks at first-line treatment with Zolbetuximab in patients with CLDN18.2-positive, HER2-negative advanced gastric cancer. It enrolls people aged 19 and older with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors show CLDN18.2 in at least 75% of cells and are HER2-negative. It is a non-phase study and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Yonsei University

Start date

12/1/2024

Estimated completion

12/1/2026

Countries

South Korea

Related genes

Locations

• Seoul, South Korea

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.