RecruitingPhase 3NCT07103668

A Phase III Randomized Study in CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer Patients

An Open-label, Randomized, Comparative Phase III Study Including Patients With CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer.


Sponsor

Suzhou Immunofoco Biotechnology Co., Ltd

Enrollment

150 participants

Start Date

Aug 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

An open-label, randomized, comparative phase II study including patients with CLDN18.2-positive unresectable locally advanced gastric cancer. To evaluate the objective response rate (ORR) and progression-free survival (PFS) of IMC002 compared with investigator's choice of treatment (ICT) as third-line or later therapy in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with positive CLDN18.2 expression.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase III study is testing a new targeted drug combination in people with stomach or esophageal junction cancer that has a protein called CLDN18.2 and cannot be surgically removed, after at least two prior treatments have failed. **You may be eligible if...** - You are 18 or older - You have locally advanced or metastatic stomach or gastroesophageal junction cancer confirmed by biopsy - Your tumor tests positive for CLDN18.2 - Your cancer has progressed or worsened on at least two prior lines of treatment - Your overall health is good enough to participate **You may NOT be eligible if...** - Your cancer has not failed at least two prior treatments - Your tumor does not express CLDN18.2 - You have uncontrolled organ problems or active infections - You cannot swallow or absorb oral medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCAR T cells

better PFS/OS data comparing to the other studies.

DRUGControl

Chemo therapy by PI options.


Locations(1)

Chinese PLA General Hospital, Beijing

Beijing, China

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NCT07103668


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