drugset
drugset / Trial / NCT04282031

A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+/HER2- Breast Cancer

NCT04282031 ↗

Phase 1/2 Recruiting 224 enrolled Beta Pharma (Suzhou) Co., Ltd.
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2020-06-15
Primary completion
2024-12-31
Completion
2025-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject BPI-1178 Unknown 25 mg Oral
Subject BPI-1178 Unknown 75 mg Oral
Subject BPI-1178 Unknown 150 mg Oral
Subject BPI-1178 Unknown 200 mg Oral
Subject BPI-1178 Unknown 250 mg Oral
Subject BPI-1178 Unknown 300 mg Oral
Subject BPI-1178 Unknown 400 mg Oral
Subject BPI-1178 Unknown 500 mg Oral
Subject Fulvestrant Small molecule 500 mg Intramuscular
Subject Letrozole Other / unclassified 2.5 mg Oral

Indications

hormone receptor-positive breast cancer