A Phase 1 Study of MEDI1873 (GITR Agonist) in Adult Subjects With Select Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
研究概览
简要总结
To evaluate the safety and tolerability of MEDI1873 in adult subjects with selected advanced solid tumors.
详细描述
This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm dose-escalation study of MEDI1873 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and anti-tumor activity in adult subjects with advanced solid tumor malignancies
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
- •All subjects must consent to provide archived tumor specimen
- •Subjects must have histologically or cytologically confirmed advanced solid tumor for recurrent or metastatic disease.
- •At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must have been treated and must be asymptomatic
- •Willingness to provide pretreatment and on-treatment biopsies.
- •Adequate organ function
- •Females of childbearing potential and nonsterilized males who are sexually active must use effective methods of contraception
排除标准
- •Known allergic reaction to any component of MEDI1873
- •Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
- •Receipt of any anticancer therapy within 4 weeks prior to the first dose of MEDI1873; in the case of mAbs, 6 weeks prior to the first dose of MEDI1873
- •Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
- •Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational product
- •Unresolved toxicities from prior anticancer therapy
- •Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.
研究组 & 干预措施
Monotherapy arm
MEDI1873
干预措施: MEDI1873 (Biological)
结局指标
主要结局
Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
时间窗: From time of informed consent through 12 months after last dose of MEDI1873
The maximum tolerated dose (MTD)/highest protocol-defined dose level in the absence of establishing an MTD will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, DLTs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.
次要结局
- Objective response rate (ORR)(Estimated to be from time of informed consent up to 4.5 years)
- Terminal half-life of MEDI1873(From first dose of MEDI1873 through to 30 days after last dose of MEDI1873)
- Maximum observed concentration (Cmax) of MEDI1873(From first dose of MEDI1873 through to 30 days after last dose of MEDI1873)
- Overall survival (OS)(Estimated to be from time of informed consent up to 4.5 years)
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of MEDI1873 through to 12 months after last dose of MEDI1873)
- Disease control rate (DCR)(Estimated to be from time of informed consent up to 4.5 years)
- Duration of response (DoR)(Estimated to be from time of informed consent up to 4.5 years)
- PD biomarkers including changes from baseline levels in various lymphocyte populations(From time of informed consent through to disease progression, assessed up to 4.5 years)
- Area under the curve (AUC) of MEDI1873(From first dose of MEDI1873 through to 30 days after last dose of MEDI1873)
- Progression-free survival (PFS)(Estimated to be from time of informed consent up to 4.5 years)
- Percentage of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of MEDI1873 through to 12 months after last dose of MEDI1873)
- Clearance (CL) of MEDI1873(From first dose of MEDI1873 through to 30 days after last dose of MEDI1873)