NCT07518147

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

A Randomized Controlled Phase III Clinical Study Comparing BL-M05D1 for Injection 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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 438 (estimated)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this trial, the experimental group receives BL-M05D1, with each treatment cycle lasting 3 weeks. The control group receives investigator-selected treatment regimens: paclitaxel, docetaxel, or irinotecan.

Conditions

• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	BL-M05D1	Administration by intravenous infusion for a cycle of 3 weeks.
DRUG	Paclitaxel	Administration by intravenous infusion for a cycle of 4 weeks.
DRUG	Docetaxel	Administration by intravenous infusion for a cycle of 3 weeks.
DRUG	Irinotecan hydrochloride	Administration by intravenous infusion for a cycle of 2 weeks.

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

1 site across 1 country: China