FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Incidence of dose-limiting toxicity (DLT)
研究概览
简要总结
This is a Phase 1, single-dose, open-label, dose-escalation study. The study will be conducted in three parts (i.e. regimens) in an outpatient setting as follows:
- Regimen A: FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies.
- Regimen B: FATE-NK100 in combination with trastuzumab in subjects with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, HER2+ advanced gastric cancer or other advanced HER2+ solid tumors.
- Regimen C: FATE-NK100 in combination with cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC), or other epidermal growth factor receptor 1 positive (EGFR1+) advanced solid tumors.
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
- •Regimen A only (monotherapy): Subjects with advanced metastatic solid tumors
- •Regimen B only (combination with trastuzumab): Subjects with advanced metastatic HER2+ solid tumors
- •Regimen C only (combination with cetuximab): Subjects with advanced metastatic EGFR+ solid tumors
- •Available related donor who is CMV+ and HLA-haploidentical or better but not fully HLA-matched
- •Presence of measurable disease by RECIST 1.1
- •Life expectancy of at least 3 months.
- •Provision of signed and dated informed consent form (ICF).
- •Stated willingness to comply with study procedures and duration.
排除标准
- •Females of reproductive potential that are pregnant or lactating, and males or females not willing to use a highly effective form of contraception from Screening through the end of the study.
- •Eastern Cooperative Oncology Group (ECOG) performance status >
- •Evidence of insufficient organ function as determined by the protocol.
- •Receipt of any biological therapy, chemotherapy, or radiation within 1 week of the Screening Visit and at least 3 weeks prior to Day 1, except for patients receiving maintenance trastuzumab.
- •Have central nervous system disease (CNS) as follows:
- •Dose Escalation Cohorts: Active CNS disease, including history of CNS metastases.
- •MTD/MFD Expansion Cohorts: CNS disease, including history of CNS metastases, that was not stable during the last 6 months.
- •Myocardial infarction (MI) within 6 months of Screening Visit.
- •Severe asthma.
- •Currently receiving or likely to require systemic immunosuppressive therapy from Day -7 to Day
- •Uncontrolled infections.
- •Presence of any medical or social issues that are likely to interfere with study conduct, or may cause increased risk to subject.
研究组 & 干预措施
Regimen A
FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies.
干预措施: FATE-NK100 (Drug)
Regimen B
FATE-NK100 in combination with trastuzumab in subjects with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, HER2+ advanced gastric cancer or other advanced HER2+ solid tumors.
干预措施: FATE-NK100 (Drug)
Regimen B
FATE-NK100 in combination with trastuzumab in subjects with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, HER2+ advanced gastric cancer or other advanced HER2+ solid tumors.
干预措施: Trastuzumab (Drug)
Regimen C
Regimen C: FATE-NK100 in combination with cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC), or other epidermal growth factor receptor 1 positive (EGFR1+) advanced solid tumors.
干预措施: FATE-NK100 (Drug)
Regimen C
Regimen C: FATE-NK100 in combination with cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC), or other epidermal growth factor receptor 1 positive (EGFR1+) advanced solid tumors.
干预措施: Cetuximab (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicity (DLT)
时间窗: 28 days
The incidence of dose-limiting toxicity (DLT) within each dose cohort within the first 28 days after FATE-NK100 administration (ie, Day 1 through Day 29).
次要结局
- Objective-response rate (ORR)(28 days, 57 days, 113 days, 169 days, 225 days, 281 days, 337 days, and 366 days.)
- Pharmacokinetics (PK) of FATE-NK100(0 days, 1 day, 3 days, 5 days, 8 days, 12 days, 15 days, 22 days, 29 days, 43 days, 57 days, 85 days, 113 days)