NCT07103668

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.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Suzhou Immunofoco Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	CAR T cells	better PFS/OS data comparing to the other studies.
DRUG	Control	Chemo therapy by PI options.

Timeline

• Start date: 2025-08-06
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2025-08-05
• Last updated: 2025-10-23

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study