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.

ABSTRACT:

Background

Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors have been approved for the treatment of hormone receptor-positive (HR⁺) and human epidermal growth factor receptor-2 negative (HER2^-) breast cancers. The study aims were to evaluate the safety, tolerability, and antitumor activity of the novel selective small molecule CDK4/6 inhibitor bireociclib in advanced solid/breast cancer (ABC) patients.

Methods

A multicenter, open-label, phase 1 trial which consisted of two parts. Part 1 evaluated bireociclib monotherapy at doses ranging from 20 mg once-daily (QD) to 480 mg twice-daily (BID), and part 2 evaluated bireociclib at the recommended dosage in combination with endocrine therapy for ABC patients, including bireociclib plus non-steroidal aroma

SUBMITTER: Wang J 

PROVIDER: S-EPMC12505607 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature