Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07518147 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this 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

StatusRecruiting
PhasePhase 3
Started2026-05-15
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint removed 2 → 1 primary endpoints
See other at-risk trials from Sichuan Baili Pharmaceutical Co., Ltd.

Amendment history

2026-07-07
Study Status, Outcome Measures v2
Primary endpoint(s) modified2 to 1 entries
WasOverall survival (OS), Progression-free survival (PFS)
NowOverall survival (OS)
Secondary endpoints5 to 7 entries
Progression-free survival (PFS) Time to Response (TTR)
2026-06-03
Study Status, Contacts/Locations v1
Recruitment opened
Start dateestimated 2026-04→confirmed 2026-05-15
Study sitesdetails revised at 1 of 1 site
2026-04-02
Original filing
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.
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