Clinical Trial

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

Recruiting Phase 3
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Summary
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M05D1 in patients with Claudin (CLDN) 18.2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC) who have received prior first-line treatment.
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-07-09
critical Recruitment opened 2026-06-05
Trial Details
NCT Number NCT07518147
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Enrollment 438 participants
Start Date 2026-05-15
Primary Completion 2029-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-08