Phase 3 Study Comparing JS107 to Investigators Choice Therapy in Adults with Advanced CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma After Prior Treatment

What this Trial Is About

Researchers are evaluating the efficacy and safety of JS107 compared to investigator-selected therapies as second-line or later treatment for patients with advanced gastric or gastroesophageal junction adenocarcinoma. The trial focuses on patients whose tumors are positive for CLDN18.2 and negative for HER2, who have already received at least one prior systemic therapy including fluorouracil and platinum. This is a randomized, controlled, open-label Phase III study enrolling about 560 participants. Participants are randomly assigned in equal numbers to either receive JS107 intravenously at 3 mgkg every 21 days or one of three chemotherapy regimens chosen by investigators irinotecan, paclitaxel, or docetaxel. These chemotherapy drugs are administered according to standard doses and schedules over 21- or 28-day cycles, with premedications given as needed. Treatment continues until disease progression, death, withdrawal, or study termination. During the study, participants will be monitored through imaging assessments to measure progression-free survival and overall survival, with other evaluations including response rates and safety outcomes up to two years or more. Tumor tissue testing for CLDN18.2 positivity is required before enrollment. The study also tracks drug concentrations and immune responses to JS107. Participation may last several years, with follow-up visits to assess treatment effects and adverse events under medical supervision.

JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma.