NCT04176757已完成1 期
A Phase 1 Open-Label, Multicenter Study to Evaluate Biomarkers for ZN-c5 in Subjects With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 10
- 主要终点
- Corroborate the single agent Recommended Phase 2 Dose
研究概览
简要总结
This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects with breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated ICF
- •Age ≥ 18 years of age, either gender
- •Females must be postmenopausal as defined by at least one of the following:
- •Age ≥ 60 years;
- •Age < 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle stimulating hormone levels within the local laboratory's normal reference range for postmenopausal females;
- •Documented bilateral oophorectomy
- •Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Adequate organ function defined as follows:
- •Hematologic: Platelets ≥ 100 × 109/L; Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count ≥ 1.5 × 109/L (without platelet transfusion or any hematopoietic growth factors within previous 7 days of the hematologic laboratory values obtained at the Screening Visit)
- •Hepatic: Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT)
- •≤ 2.5 × upper limit of normal (ULN); Total or conjugated bilirubin ≤ 1.5 × ULN
- •Renal: Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL/min
排除标准
- •Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of the first administration of study drug
- •Treatment with another investigational drug or other intervention within 28 days before the first administration of study drug
- •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication, including any unresolved nausea, vomiting, or diarrhea that is CTCAE v.5.0 Grade > 1
- •Myocardial infarction, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of study Day 1
- •Uncontrolled inter-current illness
- •History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion
研究组 & 干预措施
ZN-c5
Experimental
干预措施: ZN-c5 (Drug)
结局指标
主要结局
Corroborate the single agent Recommended Phase 2 Dose
时间窗: Throughout the study, an average of 15 months
次要结局
- Dose-biomarker relationship(Throughout the study, an average of 15 months)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
1 期
A Study of ZN-c5 and Abemaciclib in Participants With Breast CancerBreast CancerNCT04514159Zeno Alpha Inc.14
终止
1 期
ZN-c3 in Adult Participants With Metastatic Colorectal CancerMetastatic Colorectal CancerNCT05743036K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc44
撤回
1 期
A Study of GNC-035, a Tetra-specific Antibody, in Participants With Locally Advanced or Metastatic Solid TumorsSolid TumorBreast CancerNCT05039931Sichuan Baili Pharmaceutical Co., Ltd.
已完成
1 期
BAT7104 in Patients With Advanced Solid TumoursPatients With Advanced Solid TumorsNCT05200013Bio-Thera Solutions14
招募中
1 期
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBCNon-Muscle-Invasive Bladder Cancer (NMIBC)NCT06186414Jiangsu Simcere Pharmaceutical Co., Ltd.152