A Phase I Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- DLT (for Dose Escalation Phase only)
研究概览
简要总结
This is a First-in-Human Phase I trial of ATG-101 in Patients with Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas.
详细描述
This is a First-in-Human Phase I trial of ATG-101 in Patients with Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas. Dose Escalation Phase: Approximately 40-50 subjects with a maximum number of 62; 1-20 subjects for enhanced PDx cohort. Dose Expansion Phase: Estimated between 2 and 5 cohorts, each of approximately 40-50 patients to be expanded.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
- •Aged 18 to 75 years as of the date of consent.
- •Histological or cytological confirmation of a solid tumor, and has relapsed or refractory from standard therapies.
- •Subjects with solid tumors have at least 1 measurable lesion per RECIST v1.
- •Estimated life expectancy of a minimum of 12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.
排除标准
- •Subjects with CNS tumors or known CNS metastases will be excluded from the Dose Escalation Phase.
- •Prior treatment with a 4-1BB agonist.
- •Subjects with primary liver cancer.
- •Known history of human immunodeficiency virus infection.
- •History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-
- •Pregnant or nursing females.
研究组 & 干预措施
ATG-101
Dose Escalation Phase:
Will be conducted with an enhanced PDx cohort.
Dose Expansion Phase:
Subjects with advanced or metastatic solid tumors and mature B-NHLs will be enrolled.
干预措施: ATG-101 (Drug)
结局指标
主要结局
DLT (for Dose Escalation Phase only)
时间窗: One year after last patient first dose
The DLTs will be evaluated during Cycle 1 of treatment. Toxicity will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events. The DLTs for this study may include the following: Cytokine release syndrome, Hematologic toxicity, Non-hematologic toxicity.
AEs/SAEs
时间窗: One year after last patient first dose
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
次要结局
- ORR(One year after last patient first dose)
- DCR(One year after last patient first dose)
- Peak Plasma Concentration (Cmax)(One year after last patient first dose)
- Peak Plasma Concentration（Tmax）(One year after last patient first dose)
- PFS(One year after last patient first dose)
- The incidence of ADA and NAb(One year after last patient first dose)
- OS(One year after last patient first dose)