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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorYonsei University

About this trial

* Treatment effectiveness in the real world * Adverse effects * Tissue samples collected (multiplex IHC to assess PD-L1 expression, MMR gene status, and Claudin18.2) * Blood samples collected (ctDNA, scRNAseq, or immune cell profiling)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient is ≥ 19 years of age at the time of consent.

The patient must have histologically confirmed locally advanced, unresectable, or metastatic gastric or gastroesophageal junction adenocarcinoma

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.

The tumor sample must be HER2-negative (IHC 0, 1+, or IHC 2+/ISH-).

Disqualifiers

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

History of known or suspected hypersensitivity to Zolbetuximab, other monoclonal antibodies, or components of the used formulations.

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.

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.

Trial population

* Treatment effectiveness in the real world (progression-free survival, overall survival, response rate, etc.) * Adverse effects will be evaluated according to the NCI CTCAE v5.0 * Tissue samples collected before treatment, during treatment, and at disease progression will be analyzed using multiplex IHC to assess PD-L1 expression, MMR gene status, and Claudin18.2. Additionally, NGS testing will be conducted to evaluate the correlation with the treatment response to zolbetuximab. * Blood samples will be collected before treatment, during treatment, and after treatment completion to analyze ctDNA, scRNAseq, or immune cell profiling.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Treatment effectiveness

Progression-free survival, overall survival, response rate

Time frame
2 year
2

Number of participants with treatment-related adverse events as assessed by CTCAE V5.0

Adverse effects will be evaluated according to the NCI CTCAE v5.0

Time frame
2 year
3

molecular marker Analysis

* Tissue samples collected before treatment, during treatment, and at disease progression will be analyzed using multiplex IHC to assess PD-L1 expression, MMR gene status, and Claudin18.2. Additionally, NGS testing will be conducted to evaluate the correlation with the treatment response to zolbetuximab. * Blood samples will be collected before treatment, during treatment, and after treatment completion to analyze ctDNA, scRNAseq, or immune cell profiling.

Time frame
2 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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