Clinical Trial

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

Recruiting Phase 3
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-26.
Status change: Not Yet Recruiting → Recruiting 2025-11-13
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