JPRN-jRCT2031200271招募中1 期
EMBER: A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination with Anticancer Therapies for Patients with ER+ Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers - J2J-MC-JZLA
Masaki Takeshi0 个研究点目标入组 460 人开始时间: 2020年12月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 460
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •All study parts:
- •Participants must be willing to provide adequate archival tissue sample
- •Participants must be willing to use highly effective birth control
- •Participants must have adequate organ function
- •Participants must be able to swallow capsules
- •Dose escalation- Participants must have one of the following:
- •Parts A and B: ER+ HER2- breast cancer with evidence of locally advanced unresectable or metastatic disease who have had the following:
- •Part A: may have had up to 1 prior regimen of any kind for in the advanced/metastatic setting and no prior cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.
- •Part B: may have had up to 2 prior regimens, no more than 1 of which may be endocrine therapy in the advanced/metastatic setting, and must have received a prior CDK4/6 inhibitor
- •Cohort E4: No prior everolimus.
- •Part C: ER+, human epidermal growth factor receptor 2 positive (HER2+) breast cancer with evidence of locally advanced unresectable or metastatic disease who have had at least 2 HER2-directed therapies for advanced disease and prior trastuzumab, pertuzumab, and TDM-1 required in any setting.
- •Part D: ER+, EEC that has progressed after platinum containing chemotherapy and no prior fulvestrant or aromatase inhibitor therapy.
- •Participants with ER+/HER2- breast cancer enrolled in this study must have had evidence of clinical benefit while on endocrine therapy for at least 24 months in the adjuvant setting or at least 6 months in the advanced/metastatic setting or have untreated de novo metastatic breast cancer
排除标准
- •Participants must not have certain infections such as hepatitis or tuberculosis or HIV that are not well controlled
- •Participants must not have another serious medical condition
- •Participants must not have cancer of the central nervous system that is unstable
- •Participants must not be pregnant or breastfeeding
研究者
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