A Pharmacodynamic Study of Oral eFT508 in Subjects With Advanced Triple Negative Breast Cancer and Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Level of biomarkers of antitumor activation
研究概览
简要总结
This study will evaluate the pharmacodynamic (PD), safety, antitumor activity, and PK of eFT508 in female subjects who have pathologically documented, radiographically measurable, metastatic or locally advanced and unresectable TNBC and have received prior cancer therapy regimen for metastatic disease, and in male and female subjects who have histologically or cytologically confirmed advanced HCC not amenable to surgical resection and have failed systemic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TNBC Cohort
female subjects who have pathologically documented, radiographically measurable, metastatic or locally advanced and unresectable TNBC and have received >=1 prior cancer therapy regimen for metastatic disease
干预措施: eFT508 (Drug)
HCC Cohort
male and female subjects who have histologically or cytologically confirmed advanced HCC not amenable to surgical resection and have failed >=1 systemic therapy, which must include sorafenib, or are intolerant to multikinase inhibitor therapies
干预措施: eFT508 (Drug)
结局指标
主要结局
Level of biomarkers of antitumor activation
时间窗: 28 days
Biomarkers of antitumor immune activation in pre- and on treatment tumor biopsies and peripheral blood cells
次要结局
- Objective tumor response(up to 3 years)
- Progression Free Survival(up to 3 years)
- Number of mutations(up to 3 years)
- PK plasma concentrations(up to 21 weeks)
- Molecular profiling of circulating lymphocytes and tumor-infiltrating lymphocytes (TILs)(up to 3 years)
- Levels of eIF4E and phospho-eIF4E(up to 3 years)
- Proportion of subjects with TEAEs and SAEs(up to 3 years)