A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+/HER2- Breast Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeta Pharma (Suzhou) Co., Ltd.
About this trial
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 criteria
Qualifiers
Have given written informed consent prior to any study specific procedures.
Male or female, aged ≥18 years.
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 the pathology of the primary and metastatic lesions are inconsistent, diagnosis should be based on metastatic lesions' pathology.
Disqualifiers
Currently receiving or have received any CDK4/6 inhibitors.
Have had allergies or history of severe allergies.
Have participated in any clinical trials within 4 weeks prior to the dosing of BPI-1178.
Have received anti-tumor therapy (including chemotherapy, endocrine therapy, targeted therapy, immunotherapy, tumor embolization, etc.; have received radiotherapy within 2 weeks before taking the investigational product) within 4 weeks before starting to take the investigational product <except for premenopausal/perimenopausal patients with Gonadotropin-releasing hormone analogues [GnRHa] therapy allowed in Phase IIa study>.
Trial design
Treatments tested in this trial
- BPI-1178
- Fulvestrant
- Letrozole
- BPI-1178
Treatment groups
224 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov