NCT07152405

A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-positive Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction Adenocarcinoma

A Phase III Randomized Controlled Clinical Study of BL-M07D1 for Injection Versus Investigator's Choice of Chemotherapy in Patients With HER2-positive Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (G/GEJ) Adenocarcinoma After Failure of First-line Anti-HER2 Therapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 490 (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, controlled, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-positive locally advanced or metastatic gastric or gastro-esophageal junction (G/GEJ) adenocarcinoma after failure of first-line anti-HER2 therapy and first-line standard chemotherapy.

Conditions

• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	BL-M07D1	Administration by intravenous infusion for a cycle of 3 weeks.
DRUG	Investigator's choice of chemotherapy	Administration by intravenous infusion for a cycle of 2 or 3 or 4 weeks.

Timeline

• Start date: 2025-09-24
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-09-03
• Last updated: 2025-11-17

Locations

2 sites across 1 country: China