Phase III Study Comparing BL-M05D1 Injection With Standard Chemotherapy in Adults 18-75 Years With Claudin 18.2-Positive Advanced Gastric or Gastroesophageal Junction Cancer After First-Line Treatment

What this Trial Is About

Researchers are evaluating the effectiveness and safety of BL-M05D1 in patients with Claudin CLDN 18.2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma who have previously received first-line treatment. This Phase III randomized, open-label study compares BL-M05D1 with treatment regimens chosen by investigators in patients with this advanced cancer type. The study is designed to assess overall survival and other key outcomes over approximately 24 months. Participants in the experimental group receive BL-M05D1 intravenously in 3-week treatment cycles, continuing as long as there is clinical benefit and no intolerable side effects. The control group receives one of the investigator-selected intravenous treatments paclitaxel, docetaxel, or irinotecan, with cycle lengths of 2 to 4 weeks depending on the drug. Treatment continues until disease progression, intolerable toxicity, or other reasons for stopping. During the study, participants undergo regular assessments to monitor their response, side effects, and overall health. Researchers collect data on survival, progression-free survival, response rates, and treatment-related adverse events for up to 24 months. Tumor tissue samples and safety labs are also evaluated. The study requires participants to meet specific health criteria and provides comprehensive monitoring throughout treatment to ensure safety and measure outcomes.

A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-Line Treatment