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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

StatusRecruiting
PhasePhase 3
Started2025-09-24
View on ClinicalTrials.gov ↗

Amendment history

2025-11-13
Not Yet Recruiting→Recruiting Study Status, Conditions, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-09→confirmed 2025-09-24
Study sitesdetails revised at 2 of 2 sites
2025-08-26
Original filing
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.
Trial Details
NCT Number NCT07152405
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Enrollment 490 participants
Start Date 2025-09-24
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2025-11-17