A Phase I/II Study of XZP-3287 in Metastasis Solid Tumors

Summary

This study includes single agent/combination dose exploration study and the phase II study. The primary purpose of the dose exploration study is to determine the maximum tolerated dose(MTD)/recommended phase II dose(RP2D) of XZP-3287 and assess its safety and preliminary efficacy in solid tumor patients. The phase II study aims to explore the efficacy and safety profiles of XZP-3287 as a single- agent in hormone receptor(HR) positive, human epidermal growth factor receptor 2(HER2) negative advanced breast cancer.

Timeline

Start

2018-05-22

Primary completion

2023-07-31

Completion

2025-12-31

Publications

• Wang J, Sun T, Tong Z, Hu X, Li W, Yan M, Liu Y, Ouyang Q, Liu X, Fang J, Li H, Li H, Chen W, Gong C, Teng Y, Xu L, Duan X, Liu M, Meng Y, Liu F, Wang L, Xu B. Safety and tolerability of bireociclib for the treatment of advanced solid tumors as monotherapy and in combination with endocrine therapy: a multicenter, open-label, phase 1 clinical trial. BMC Med. 2025 Oct 8;23(1):546. doi: 10.1186/s12916-025-04364-9.
• Wang J, Zhang Q, Sun T, Li H, Cheng Y, Tong Z, Li H, Li W, Wang J, Teng Y, Wu X, Cheng J, Chen Z, Zhu Z, Wang L, Liu M, Duan X, Xu L, Xu B. An open-label, single-arm, multicenter, phase II trial of bireociclib as monotherapy for heavily pretreated HR-positive, HER2-negative advanced breast cancer patients: BRIGHT-1 trial. Cancer Commun (Lond). 2025 Jun;45(6):640-653. doi: 10.1002/cac2.70009. Epub 2025 Feb 27.

Drugs

Indications