EUCTR2019-002956-18-ES进行中（未招募）1 期
Phase 2a Study of ZW25 in Combination with Palbociclib Plus Fulvestrant
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Pathologically-confirmed diagnosis of breast cancer with evidence of locally advanced (unresectable) and/or metastatic disease. All patients in both Parts 1 and 2 must have HER2+ and HR+ disease as follows:
- •HER2+ based on the HER2 Testing in Breast Cancer: American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Clinical Practice Guidelines.
- •HR+ defined as estrogen-receptor positive (ER+) and/or progesterone-receptor positive (PgR+) disease based on the ASCO/CAP Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer.
- •2.Able to provide a new formalin-fixed, paraffin-embedded (FFPE) tumor sample (preferred) or archived tumor tissue (most recent sample available) for retrospective central review of HER2 status.
- •Local assessments performed on a new tumor sample or archived tumor tissue in a Clinical Laboratory Improvements Amendments (CLIA)-certified lab using a combination of IHC and ISH/FISH methods may be used to determine HER2 and HR status for study eligibility. IHC must be used to determine HR status. Unless otherwise approved by the sponsor medical monitor, specimens should be provided for centralized retrospective review of HER2 status.
- •3.Disease that has progressed on or been refractory to prior treatment with trastuzumab, pertuzumab, AND ado-trastuzumab emtansine (T-DM1). Patients in any part of the study who did not receive pertuzumab or T-DM1 because of lack of access (e.g., due to insurance coverage or because they were treated prior to regulatory agency approval of the agent in a relevant indication) or due to medical ineligibility for treatment with T-DM1 (e.g., history of severe infusion reactions to trastuzumab, = Grade 2 peripheral neuropathy, or platelet count < 100 x 10E9/L) may be eligible for the study after discussion with and approval from the sponsor medical monitor. Prior treatment with endocrine therapy in the neoadjuvant, adjuvant, and/or metastatic setting is permitted.
- •4.Sites of disease assessible per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (both measurable and non-measurable disease allowed)
- •5.Male and female patients aged 18 years or older
- •6.An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- •7.Life expectancy of at least 3 months in the opinion of the investigator
- •8.The following baseline laboratory data:
- •a.Absolute neutrophil count (ANC) = 1.5 x 10E9/L
- •b.Platelet count = 75 x 10E9/L
- •c.Hemoglobin = 9 g/dL
- •d.Prothrombin time (PT) and/or International Normalized Ratio (INR) and partial thromboplastin time (PTT)= 1.5 x upper limit of normal (ULN), unless on medication known to alter the INR or PTT
- •e.Total bilirubin = 1.5 x ULN per institutional values (patients with known Gilbert’s Syndrome may enroll with 2.5 x ULN provided the direct bilirubin is = 1.5 mg/dL)
- •f.Alanine transaminase (ALT) = 3.0 x ULN per institutional values (if liver metastases are present, = 5.0 x ULN)
- •g.Aspartate transaminase (AST) = 3.0 x ULN per institutional values (if liver metastases are present, = 5.0 x ULN)
- •h.Serum creatinine = 1.5 X ULN or calculated glomerular filtration rate 50 mL/min
- •9.Adequate cardiac left ventricular function, as defined by LVEF = institutional standard of normal
- •10.All toxicity related to prior cancer therapies must have resolved to = Grade 1, with the exception of alopecia or = Grade 2 neuropathy
- •11.If female and of child-bearing potential, must have a negative
排除标准
- •1.Prior treatment with trastuzumab, pertuzumab, lapatinib, T-DM1, or other anti-HER2-targeted therapy = 3 weeks before the first dose of ZW25
- •2.Prior treatment with chemotherapy, other anti-cancer therapy not otherwise specified, or hormonal cancer therapy = 3 weeks before the first dose of ZW25
- •3.Prior treatment with experimental biologic and non-biologic therapies = 4 weeks before the first dose of ZW25
- •4.Prior treatment with radiation therapy other than for central nervous system (CNS) disease = 3 weeks before the first dose of ZW25
- •5.Treatment with anthracyclines within 90 days before first dose of ZW25 and/or total lifetime load exceeding 360 mg/m2 Adriamycin or equivalent
- •6.Use of any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes within 7 days of first dose of any study drug
- •7.History of life-threatening hypersensitivity to monoclonal antibodies, recombinant proteins, or excipients in the drug formulation
- •8.Prior treatment with palbociclib or any other CDK4/6 inhibitors, including experimental agents
- •9.Use of corticosteroids administered at doses equivalent to > 15 mg per day of prednisone within 2 weeks of first ZW25 dosing unless otherwise approved by the sponsor medical monitor. Topical, ocular, intra-articular, intranasal, and/or inhalational corticosteroids are permitted.
- •10.History of myocardial infarction or unstable angina within 6 months prior to enrollment, troponin levels consistent with myocardial infarction, or clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension, or any history of symptomatic congestive heart failure (CHF)
- •11.QTc Fridericia (QTcF) >450 ms
- •12.Grade 2 or greater pneumonitis and/or interstitial lung disease, including pulmonary fibrosis, or other clinically significant infiltrative pulmonary disease not related to lung metastases
- •13.Active hepatitis B or hepatitis C infection
- •14.Acute or chronic uncontrolled renal disease, pancreatitis, or severe liver disease (Child-Pugh Class C)
- •15.Known infection with Human Immunodeficiency Virus (HIV)-1 or HIV-2 (Exception: patients with well- controlled HIV [e.g., cluster of differentiation 4 (CD4)-positive T cell count >350/mm3 and undetectable viral load] are eligible.)
- •16.Major surgery = 3 weeks prior to the first dose of ZW25
- •17.Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
- •18.Any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
- •19.Females who are breastfeeding or pregnant, and females and males planning a pregnancy
- •20.Brain metastases: Untreated CNS metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks of start of study treatment. Stable, treated brain metastases are allowed (defined as patients who are off steroids and anticonvulsants and are neurologically stable for at least 1 month at the time of screening).
- •21.Poorly-controlled seizures
- •22.Known leptomeningeal disease (LMD). If LMD has been reported radiographically on baseline magnetic resonance imaging (MRI), but is not suspected clinically by the investigator, the patient must be free of neurological symptoms of LMD.
- •23.Grade 3 or greater peripheral neuropathy
研究者
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