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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
BPI-1178
DrugBPI-1178 once daily on Days 1 to 21 of a 28-day cycle
Fulvestrant
DrugFulvestrant 500mg intramuscularly on Days 1 and 15 of Cycle 1, and on Day 1 of Cycle 2 and beyond
Letrozole
DrugLetrozole 2.5 mg once daily of a 28-day cycle
BPI-1178
DrugBPI-1178 once daily of a 28-day cycle
Treatment groups
224 Participants
are divided into 3 treatment groupsGroup A: phase 1 (dose escalation study, dose expansion study and PK trail)Experimental treatment 1 intervention
Group B: phase 2a cohort AExperimental treatment 2 interventions
Group C: phase 2a cohort BExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
phase 1 and 2a: Number of subjects with dose limiting toxicity (DLT)
Time frame
Up to Day 28 of Cycle 1 (28 days/cycle)2
phase 1: Maximum tolerated dose (MTD)
Time frame
Up to Day 28 in Cycle 1 (28 days/cycle)3
phase 2a: Objective response rate (ORR)
Time frame
Up to approximately 18 monthsSecondary outcomes
1
phase 1 and 2a: Number of subjects with adverse events
Time frame
Up to 30 days after the last dose of BPI-11782
phase 1: Objective response rate (ORR)
Time frame
Up to approximately 18 months3
Phase 1 and 2a: Maximum plasma concentration (Cmax) of BPI-1178 and its main metabolites
Time frame
From single dosing in phase 1 or from baseline in phase 2a to the end of Cycle 1 (28 days/cycle)4
Phase 1 and 2a: Peak Plasma Time (Tmax) of BPI-1178 and its main metabolites
Time frame
From single dosing in phase 1 or from baseline in phase 2a to the end of Cycle 1 (28 days/cycle)Other outcomes
1
Clearance of BPI-1178 and its main metabolites
Time frame
From single dosing in phase 1 or from baseline in phase 2a to the end of Cycle 1 (28 days/cycle)2
Half life of BPI-1178 and its main metabolites
Time frame
From single dosing in phase 1 or from baseline in phase 2a to the end of Cycle 1 (28 days/cycle)3
Disease control rate ( DCR)
Time frame
Up to approximately 18 months4
Duration of response ( DoR)
Time frame
Up to approximately 18 monthsSponsors and contacts
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Source ClinicalTrials.gov