Actively Recruiting
A Phase 1/2a Study Evaluating Safety, Pharmacokinetics, and Efficacy of Oral BPI-1178 Alone and with Endocrine Therapy in Advanced Solid Tumors and HR+/HER2- Breast Cancer
Led by Beta Pharma (Suzhou) Co., Ltd. · Updated on 2024-08-07
224
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying BPI-1178, a new oral drug that blocks CDK4 and CDK6 enzymes, in patients with advanced solid tumors and hormone receptor-positive, HER2-negative breast cancer. This first-in-human Phase I trial focuses on evaluating the safety, tolerability, and how the drug behaves in the body. In Phase IIa, the study explores the anti-tumor effects and safety of BPI-1178 combined with endocrine therapies in breast cancer patients, aiming to define proper dosing for future studies. The study has two main parts: Phase 1 uses a 3+3 dose escalation design to test increasing doses of BPI-1178 alone in advanced solid tumor patients, determining the maximum tolerated dose. Participants first receive a single dose followed by continuous daily dosing in 28-day cycles. Phase 2a evaluates BPI-1178 combined with fulvestrant or letrozole in breast cancer patients, using intermittent or continuous dosing schedules within 28-day cycles. Treatment continues until disease progression or unacceptable side effects. Participants undergo screening up to 28 days before enrollment, followed by treatment and regular follow-up every three months until death or study end. Safety is closely monitored by tracking dose-limiting toxicities and adverse events. Effectiveness is assessed every two months using tumor response criteria. Blood samples are collected for pharmacokinetic analysis throughout the trial to understand drug levels and metabolism. Overall, the study involves ongoing evaluation of safety, response, and drug behavior to support further development of BPI-1178.
CONDITIONS
Brief 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...
- Male or female aged 18 years or older
- Written informed consent obtained before study procedures
- Advanced solid tumors refractory to standard therapy or with no standard treatment (Phase 1)
- HR+/HER2- advanced or recurrent breast cancer with progression after first-line endocrine therapy or intolerance (Phase 2a Cohort A)
- HR+/HER2- advanced or recurrent breast cancer with no prior systemic therapy or relapse over 1 year after adjuvant endocrine therapy (Phase 2a Cohort B)
- Postmenopausal or premenopausal/perimenopausal breast cancer patients meeting specified hormonal criteria (Phase 2a)
- At least one measurable lesion by 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 tests
- Use of effective contraception during the study and after last dose
- Mental ability to understand the study and associated risks
You will not qualify if you...
- Current or prior treatment with any CDK4/6 inhibitors
- History of severe allergies
- Participation in another clinical trial within 4 weeks before dosing
- Anti-tumor therapy within 4 weeks before dosing except allowed GnRHa therapy in Phase 2a
- Presence of other active malignancies at enrollment (Phase 2a only)
- Grade 2 or higher toxicity from previous treatments except hair loss
- Uncontrolled third-space fluid such as pleural effusion or ascites
- Need for long-term steroid treatment
- Uncorrectable low potassium or magnesium levels
- Significant heart rhythm or conduction abnormalities and recent serious cardiac events
- Active infections including hepatitis B, hepatitis C, or HIV
- History of organ or stem cell transplantation
- Gastrointestinal conditions affecting drug absorption
- Symptomatic spinal cord compression or brain metastases unless stable and asymptomatic
- Severe comorbid diseases affecting safety or study completion
- Major surgery or unhealed wounds within 4 weeks before dosing
- Pregnant or breastfeeding women or positive pregnancy test
- Drug abuse, addiction, mental illness, or social issues interfering with participation
- Any condition that might endanger safety or compliance as judged by investigators
- Unwillingness or inability to comply with study requirements
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable; treatment cycles of 28 days repeated until disease progression or unacceptable toxicity
Participants receive BPI-1178 orally with dosing schedules varying by study phase and cohort. Phase 1 involves a single dose followed by a washout period, then continuous 28-day cycles with daily dosing for 3 weeks and 1 week off. Phase 2a involves BPI-1178 combined with either fulvestrant or letrozole, administered in 28-day cycles with either 3 weeks on and 1 week off dosing or continuous dosing, continued until disease progression or unacceptable toxicity.
Visits every 2 months for efficacy assessments; continuous monitoring for adverse events
Duration - Every 3 months until death or study end
Participants are monitored every 3 months after treatment ends until death or the end of the study to assess long-term safety and survival.
Quarterly visits (in-person or remote)
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
W
Wenxiang Lu
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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