drugset / Trial / NCT07103668

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

NCT07103668

Phase 3 Recruiting 150 enrolled Suzhou Immunofoco Biotechnology Co., Ltd
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-08-06
Primary completion
2027-05-31
Completion
2027-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject CAR-T cells Cell therapy