Actively Recruiting
An Open, Multicenter Study on Safety, Tolerance, Pharmacokinetics, and Initial Efficacy of HRS-2189 Combined With Fluvastatin or HRS-6209, HRS-8080, and HRS-1358 in Advanced Unresectable or Metastatic Breast Cancer
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-03-02
300
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerance, pharmacokinetics, and initial efficacy of HRS-2189 combined with Fluvastatin and other investigational drugs in adult women with advanced unresectable or metastatic breast cancer. This open, multicenter Phase IbII study aims to find the maximum tolerated dose and recommend a dose for Phase II, focusing on patients whose cancer has progressed despite previous treatments. The study explores different drug combinations to understand their effects in this patient group. Participants will receive one of several experimental treatment combinations involving HRS-2189 with Fluvastatin, HRS-6209, HRS-8080, or HRS-1358. The study includes multiple treatment groups with these combinations, administered under medical supervision. The trial is non-randomized and open-label, meaning both researchers and participants know the treatments given. Treatments and their effects will be monitored over time, especially during the first 28 days and continuing with efficacy evaluations every 8 weeks for about a year. During the study, participants will undergo regular assessments including safety monitoring for adverse events and dose-limiting toxicities, pharmacokinetic testing, and imaging to measure tumor response. Researchers will track objective response rates, duration of response, disease control, clinical benefit, and progression-free survival. Blood samples will be analyzed for antibody levels and gene mutations related to treatment response and resistance. The trial includes ongoing evaluations to ensure participant safety and follow-up for up to 30 days after the last treatment dose.
CONDITIONS
Brief Title
A Trial of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 to 75 years
- ECOG physical condition score of 0 or 1
- Confirmed advanced unresectable or metastatic breast cancer by histopathology or cytopathology
- Menopausal status
- Previous treatments including adjuvant endocrine therapy with or without CDK4/6 inhibitors, and chemotherapy with specified timing criteria
- Disease progression confirmed by imaging before first medication use (for efficacy expansion stage)
- At least one measurable extracranial lesion meeting RECIST v1.1 at baseline
- Expected survival greater than 3 months
- Good function of eight major organs
- Specific intervals required after prior treatments, including nitrosourea, mitomycin C, cytotoxic drugs, endocrine therapy, immunotherapy, targeted therapy, and radiotherapy
- Female participants with fertility must agree to use effective contraception during and for 7 months after study treatment
- Negative serum HCG test within 7 days prior to enrollment and non-lactating status
- Voluntary participation with signed informed consent and willingness to comply with study procedures
You will not qualify if you...
- Active or symptomatic brain metastases, cancerous meningitis, spinal cord compression, or primary CNS tumors; asymptomatic brain metastases must be treated and stable for at least 28 days
- Severe cardiovascular disease including congestive heart failure NYHA Class >2, severe angina, recent myocardial infarction, significant arrhythmias, atrial fibrillation, or cerebrovascular symptoms
- Conditions affecting oral medication intake or significant gastrointestinal diseases impacting drug absorption
- Uncontrollable third space effusions or cancerous lymphedema
- Pregnant, nursing, or planning pregnancy during the study
- Significant liver disease or untreated active hepatitis B or C
- Uncontrolled chronic systemic diseases such as severe lung, liver, kidney, or heart conditions
- Active autoimmune diseases or history of immune deficiency, including HIV infection or organ transplantation
- Active infectious tuberculosis requiring treatment
- History of other malignancies within 5 years except certain cured skin or cervical cancers
- Use of strong or moderate CYP3A4 inhibitors or inducers shortly before first dose
- History of neurological or psychiatric disorders or substance abuse
- Expected to receive other anti-tumor treatments during the study
- Serious physical or laboratory abnormalities increasing study risk
- Previous anti-tumor treatment toxicities except tolerable chronic Grade II toxicities
- Allergy to any study drug or excipient
Research Team
X
Xia Zhang, M.M
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