A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+/HER2- Breast Cancer
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 Pha
| Condition(s) | Advanced Solid Tumor, HR+/HER2- Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Have given written informed consent prior to any study specific procedures. 2. Male or female, aged ≥18 years. 3. Subjects with advanced solid tumors: * Phase 1: Histologically or cytologically confirmed, locally advanced (not amenable to curative treatment of surgical resection or radiation therapy), recurrent, or metastatic solid tumors that were refractory to standard therapy or for which no standard-of-care therapy. * Phase 2a Cohort A: HR+/HER2- locally advanced, recurrent, or metastatic breast cancer with disease progression after first-line endocrine therapy (not fulvestrant) or intolerant of it, histologically confirmed by the primary and/or metastatic lesions, not amenable to chemotherapy or curative treatment of surgical resection or radiation therapy; if t |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Beta Pharma (Suzhou) Co., Ltd. |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2020-06-15 |
| NCT ID | NCT04282031 |
| Official listing | https://clinicaltrials.gov/study/NCT04282031 |