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

NCT07103668 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-10-23

No results posted yet for this study

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

DRUG

CAR T cells

better PFS/OS data comparing to the other studies.

DRUG

Control

Chemo therapy by PI options.

Sponsors & Collaborators

  • Suzhou Immunofoco Biotechnology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-06
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07103668 on ClinicalTrials.gov