drugset / Trial / NCT04908787
A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer
Phase 3
Completed
421 enrolled
Jiangsu Simcere Pharmaceutical Co., Ltd.
Shanghai Xianxiang Medical Technology Co., Ltd. · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The standard systemic treatment for ovarian cancer is platinum-based chemotherapy. However, majority of patients relapse and eventually progress to platinum resistance. In patients with platinum-resistant or refractory ovarian cancer, effective treatment options are limited and the prognosis is very poor. Angiogenesis is essential for tumor growth and metastasis, and VEGF/VEGF receptor(VEGFR) signaling pathway is the most promising angiogenic target. This study aim to assess the efficacy and safety of the combination BD0801 and chemotherapy in patients with platinum-resistant recurrent ovarian cancer.
Timeline
- Start
- 2021-06-11
- Primary completion
- 2023-12-08
- Completion
- 2024-10-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Suvemcitug | Monoclonal antibody | 1.5 mg/kg | Intravenous |
| Background | Doxorubicin | Other / unclassified | 40 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Background | Topotecan | Small molecule | 4 mg/m2 | Intravenous |