Actively Recruiting
A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+/HER2- Breast Cancer
Led by Beta Pharma (Suzhou) Co., Ltd. · Updated on 2024-08-07
224
Participants Needed
1
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+/HER2- Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent before any study procedures
- Male or female aged 18 years or older
- For Phase 1: Diagnosed with advanced solid tumors that have not responded to standard treatments or have no standard treatments available
- For Phase 2a Cohort A: Diagnosed with hormone receptor-positive, HER2-negative advanced or recurrent breast cancer that progressed after or is intolerant to first-line endocrine therapy (not fulvestrant)
- For Phase 2a Cohort B: Diagnosed with hormone receptor-positive, HER2-negative advanced or recurrent breast cancer with no prior systemic therapy in this setting or relapse over 1 year after adjuvant endocrine therapy
- Postmenopausal female patients meeting defined criteria or premenopausal/perimenopausal patients requiring ovarian suppression in Phase 2a
- At least one measurable tumor lesion based on RECIST v1.1
- Life expectancy of at least 12 weeks
- ECOG Performance Status of 0 or 1
- Adequate bone marrow and organ function as defined by laboratory criteria
- Use of effective contraception during and after the study as specified
- Ability to understand the study and its risks
You will not qualify if you...
- Currently receiving or previously treated with any CDK4/6 inhibitors
- History of allergies or severe allergic reactions
- Participation in other clinical trials within 4 weeks before starting this study
- Received anti-tumor therapy within 4 weeks prior to study drug, except allowed ovarian suppression therapy in Phase 2a
- Presence or treatment of other malignancies at enrollment (Phase 2a only)
- Significant toxicity from prior treatments (grade 2 or higher except hair loss)
- Uncontrolled fluid buildup such as large pleural effusion or ascites
- Need for long-term steroid treatment
- Uncorrectable low potassium or magnesium levels
- Serious heart rhythm or conduction abnormalities or recent serious heart diseases
- Active infections including hepatitis B, hepatitis C, or HIV
- History of organ or stem cell transplantation
- Gastrointestinal conditions affecting drug absorption or ability to swallow
- Symptomatic spinal cord compression or brain metastases requiring treatment
- Severe concurrent diseases affecting safety or study completion
- Major surgery or unhealed wounds within 4 weeks before starting drug
- Pregnancy, breastfeeding, or positive pregnancy test at baseline
- Drug abuse, addiction, mental illness, or social barriers interfering with study participation
- Any condition judged by investigators to make participation unsafe or unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
W
Wenxiang Lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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