drugset / Trial / NCT06304974
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus01)
Phase 3
Active not recruiting
497 enrolled
Sichuan Baili Pharmaceutical Co., Ltd.
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a registered phase Ill, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic esophageal squamous cell carcinoma after failure of PD-1/PD-L1 monoclonal antibody in combination with platinum-based chemotherapy.
Timeline
- Start
- 2024-03-19
- Primary completion
- 2026-05
- Completion
- 2026-05
Outcome
Met primary endpoint
release “在食管鳞癌 的 III 期临床试验（研究方案编号： BL-B01D1-305）中，经独立数据监查委员会（iDMC）判断，在预设的期中分析中 达到无进展生存期（PFS）和总生存期（OS）双主要终点” cninfo.com.cn ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BL-B01D1 | Unknown | — | Intravenous |
| Subject | Docetaxel | Small molecule | — | Intravenous |
| Subject | Irinotecan | Small molecule | — | Intravenous |
| Subject | Paclitaxel | Small molecule | — | Intravenous |