drugset / Trial / NCT07582315
A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)
Phase 3
Not yet recruiting
538 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-B01D1 compared with the investigator's choice of protocol in patients with locally advanced or metastatic biliary tract cancer who have failed prior platinum-based chemotherapy.
Timeline
- Start
- 2026-07
- Primary completion
- 2028-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BL-B01D1 | 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 |