drugset / Trial / NCT07606599
A Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure
Phase 3
Not yet recruiting
398 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-M07D1 in patients with HER2-expressing locally advanced or metastatic biliary tract cancer after platinum-containing chemotherapy failure.
Timeline
- Start
- 2026-05
- Primary completion
- 2028-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BL-M07D1 | Unknown | — | Intravenous |
| Comparator | Capecitabine | Small molecule | — | Oral |
| Comparator | Irinotecan | Small molecule | — | Intravenous |
| Comparator | Irinotecan Hydrochloride Liposome | Unknown | — | Intravenous |
| Comparator | Levoleucovorin | Unknown | — | Intravenous |
| Comparator | Oxaliplatin | Small molecule | — | Intravenous |
| Comparator | fluorouracil | Small molecule | — | Intravenous |