drugset / Trial / 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
Phase 3
Recruiting
438 enrolled
Sichuan Baili Pharmaceutical Co., Ltd.
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-05-15
- Primary completion
- 2029-12
- Completion
- 2029-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BL-M05D1 | Unknown | — | Intravenous |
| Comparator | Docetaxel | Small molecule | — | Intravenous |
| Comparator | Irinotecan | Small molecule | — | Intravenous |
| Comparator | Paclitaxel | Small molecule | — | Intravenous |