BG01-2201L

NCT05430854 📎

Regimen

Experimental
Birociclib (BPI-16350, XZP-3287) 450 mg QD + fulvestrant 500 mg IM.
Control
Placebo + fulvestrant 500 mg IM.

Population

HR+/HER2- metastatic breast cancer previously treated with >=1 line of endocrine therapy in the advanced setting; mixed CDK4/6-naive and CDK4/6-experienced populations per cohort.

Key finding

Birociclib is the next Chinese-developed CDK4/6 inhibitor (after dalpiciclib) in late-stage HR+/HER2- MBC development. Phase 3 readout positions birociclib for NMPA review as another domestic CDK4/6 option. Reinforces Chinese CDK4/6 class maturation beyond dalpiciclib.

Timeline

    Guideline citations

    • NCCN BREAST