A Phase 1b Study of ZN-c5 in Combination With Abemaciclib in Patients With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 5
- 主要终点
- Incidence and severity of adverse events from ZN-c5 in combination with abemaciclib
研究概览
简要总结
This is a Phase 1b, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-c5 administered orally in combination with abemaciclib (VERZENIO®) in participants with advanced estrogen-receptor positive, human epidermal growth factor receptor-2 negative (ER+/HER2-) 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
- •Age ≥ 18 years of age
- •Women can be peri- or 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 (FSH) level within the laboratory's reference range for postmenopausal females;
- •Documented bilateral oophorectomy;
- •Must receive a gonadotrophin-releasing hormone agonist beginning at least 4 weeks prior to the first dose of study medication
- •Histologically or cytologically confirmed diagnosis of advanced adenocarcinoma of the breast
- •Estrogen receptor positive disease
- •Human Epidermal Growth Factor Receptor 2 negative disease
- •Measurable disease per Response Evaluation Criteria in Solid Tumors v1.1
排除标准
- •Prior therapy within the following windows:
- •Tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine therapy < 14 days;
- •Any investigational drug therapy < 28 days or 5 half-lives (whichever is shorter)
- •Any prior systemic chemotherapy regardless of the stop date, but the subject must have recovered to eligibility levels from prior toxicity
- •Prior treatment with CDK4/6 inhibitors
- •Unexplained symptomatic endometrial disorders (including, but not limited to, endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)
研究组 & 干预措施
ZN-c5 + abemaciclib combination therapy
Participants will take abemaciclib (150mg) orally twice a day and ZN-c5 (dose escalation) orally once or twice a day to determine the safety, tolerability, and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D).
干预措施: ZN-c5 (Drug)
ZN-c5 + abemaciclib combination therapy
Participants will take abemaciclib (150mg) orally twice a day and ZN-c5 (dose escalation) orally once or twice a day to determine the safety, tolerability, and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D).
干预措施: Abemaciclib (Drug)
结局指标
主要结局
Incidence and severity of adverse events from ZN-c5 in combination with abemaciclib
时间窗: Through study completion, anticipated to be 21 months
Measured by the number of treatment-emergent adverse events and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
次要结局
- Determine tumor responses to combination treatment(Through study completion, anticipated to be 21 months)