drugset / Trial / NCT04734262
A Phase II Study to Explore the Safety, Tolerability, and Preliminary Antitumor Activity of Sitravatinib Plus Tislelizumab or Combination With Nab-paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of this study is to assess the efficacy and safety of sitravatinib plus tislelizumab or combination with nab-paclitaxel in locally recurrent or metastatic triple-negative breast cancer (TNBC) patients.
Timeline
- Start
- 2021-04-01
- Primary completion
- 2026-06-01
- Completion
- 2027-06-30
Publications
- Background Liu XY, Sui XY, Xu Y, Yang F, Wu SY, Zhu XZ, Zuo K, Cao SW, Jin X, Chen L, Ma LX, Zhang WJ, Ye FG, Qu FL, Ma D, Xiao Y, Di GH, Liu GY, Yu KD, Wu J, Hu X, Jiang YZ, Wang ZH, Shao ZM, Fan L. Sitravatinib plus tislelizumab in locally recurrent or metastatic triple-negative breast cancer: a multi-cohort, single-arm, phase II clinical trial (SPARK Trial). Mol Cancer. 2025 Dec 19;25(1):15. doi: 10.1186/s12943-025-02505-5.
- Background Xiyu Liu, Ying Xu, Xiuzhi Zhu, Wenjuan Zhang, Linxiaoxi Ma, Xi Jin, Songyang Wu, Han Wang, Shen Zhao, Yi Xiao, Li Chen, Min He, Wei Zhu, Zhigang Zhuang, Fengyi Hou, Ayong Cao, Genhong Di, Jiong Wu, Keda Yu, Guangyu Liu, Xin Hu, , Yizhou Jiang, Zhonghua Wang, Lei Fan, Zhiming Shao. Tislelizumab plus sitravatinib and nab-paclitaxel in patients with untreated locally recurrent or metastatic triple negative breast cancer (TNBC): updated efficacy and safety results [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr PS3-01.
- Background L. Liu, X. Jin, Y. Xu, S. Wu, Y. Yang, L. Chen, W. Zhang, L. Ma, X. Hu, Z. Wang, Y. Jiang, Z. Shao. The safety, tolerability, and preliminary antitumor activity of sitravatinib plus tislelizumab in patients (pts) with locally recurrent or metastatic triple negative breast cancer (TNBC): a multi-cohort, phase II trial. Annals of Oncology (2022) 16 (suppl_1): 100102-100102. 10.1016/iotech/iotech100102
- Results Lei Fan, Xiyu Liu, Xi Jin, Yunsong Yang, Li Chen, Xin Hu, Zhonghua Wang, Yizhou Jiang, and Zhimin Shao. The safety, tolerability, and preliminary antitumor activity of sitravatinib plus tislelizumab in patients with locally recurrent or metastatic triple-negative breast cancer.Journal of Clinical Oncology 2022 40:16_suppl, 1070-1070
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nab-paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Sitravatinib | Small molecule | 70 mg | Oral |
| Subject | Sitravatinib | Small molecule | 100 mg | Oral |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |