Phase III Study Comparing IMC002 CAR-T Cell Therapy to Investigators Choice in Adults with CLDN18.2-positive Unresectable Locally Advanced or Metastatic Gastric Cancer

What this Trial Is About

Researchers are studying patients with CLDN18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have not responded to at least two prior treatments. The study aims to compare the objective response rate and progression-free survival of a new treatment called IMC002 against the investigators choice of treatment as a third-line or later therapy. This is an open-label, randomized phase III trial designed to better understand treatment outcomes in this patient group. Participants will receive either IMC002 CAR-T cell therapy or a control treatment chosen by their investigator, which may include chemotherapy options. Treatment will be given after randomization, and the study will monitor patients over time to evaluate how well each treatment controls the cancer. The trial includes regular assessments to track tumor response and disease progression. During the study, participants will undergo scheduled evaluations including laboratory tests and imaging to measure tumor size and progression using RECIST 1.1 criteria. Researchers will monitor safety and efficacy outcomes such as progression-free survival up to 96 weeks after randomization. Patients will be followed to assess overall survival and treatment impact, with ongoing medical support and monitoring throughout the trial duration.

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