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)

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

2024-06-30

Completion

2024-06-30

Publications

• 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
• Results 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
• 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.

Drugs

Indications