A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+/HER2- Breast Cancer
A Phase 1/2a Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Efficacy of BPI-1178 Alone in Advanced Solid Tumor and of BPI-1178 in Combination With Endocrine Therapy in Advanced HR+/HER2- Breast Cancer
Beta Pharma (Suzhou) Co., Ltd.
224 participants
Jun 15, 2020
INTERVENTIONAL
Conditions
Summary
BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4(CDK4)and CDK6 kinase activity. This Phase I study is a first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of oral BPI-1178 in patients with advanced solid tumors. The Phase IIa trial is designed to investigate the anti-tumor activity and safety of BPI-1178 in combination with endocrine therapy in patients with HR+/HER2-advanced breast cancer and to determine the dosing regimen for combination with endocrine therapy in a later confirmatory study.
Eligibility
Plain Language Summary
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Interventions
BPI-1178 once daily on Days 1 to 21 of a 28-day cycle
Fulvestrant 500mg intramuscularly on Days 1 and 15 of Cycle 1, and on Day 1 of Cycle 2 and beyond
Letrozole 2.5 mg once daily of a 28-day cycle
BPI-1178 once daily of a 28-day cycle
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04282031