BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4CDK4and
CDK6 kinase activity. The purpose of this study is to evaluate the safety, efficacy and
pharmacokinetics of BPI-1178 in subjects with advanced solid tumor, as well as the subjects
with advanced hormone receptor-positive(HR+)/human epidermal growth factor receptor 2
negative (HER2-) breast cancer.
This is a study which consists of phase studydose escalation stage) and phase 2a study
Phase 1 study will adopt the classical 3+3 dose escalation design, exploring the safety and
tolerance of 5 dose cohorts (25mg, 75mg, 150mg, 250mg and 400mg) in subjects with advanced
solid tumor and determining the maximum tolerated dose of BPI-1178 for phase 2a study.
Phase 2a is an expansion study in subjects of HR+/HER2- breast cancer using 3+3 design, to
evaluate the efficacy and safety of BPI-1178 in combination with endocrine therapy. Cohort A
is BPI-1178 in combination with fulvestrant for advanced or recurrent HR+/HER2- breast cancer
after failure or intolerance of first-line standard therapy. Cohort B is BPI-1178 in
combination with letrozole for advanced or recurrent HR+/HER2- breast cancer as first-line
Phase 1 and 2a consist of screening period (28 days before enrollment), treatment period and
follow up period (every 3 months until death or the end of study). Subjects will receive
BPI-1178 daily for 3 weeks, followed by 1 week-off treatment. Once the maximum tolerated dose
(MTD) is reached in phase 1, phase 2a study will explore the dose of BPI-1178 from MTD to
MTD-1 and MTD-2 level in combination with fulvestrant or letrozole.
Dose limiting toxicity (DLT) will be recorded for the single dose period of 7 days and the
multiple dose period up to 28 days in phase 1 study, as well as 28 days after the first dose
of BPI-1178 in phase 2a. Efficacy will be evaluated by RECIST v1.1 and the Response
Assessment in Neuro-Oncology Brain Metastases (RANO-BM) every 2 months. Adverse events will
be monitored throughout the trial. Other exploration of pharmacokinetic information will be
assessed throughout the trial.
breast tumor, breast tumors, Advanced Malignant Solid Tumor, Breast Cancer, Advanced Solid Tumor, tumor of the breast
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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