A Phase 2 Study of NGM707 in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Objective response rate (ORR) as per RECIST v1.1
研究概览
简要总结
Study of NGM707 in Combination With Pembrolizumab in Advanced or Metastatic 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
- •Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy.
- •Patients must not be amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
- •Have at least 1 measurable lesion per RECIST v1.1 criteria.
- •Adequate bone marrow, kidney and liver function.
- •Performance status of 0 or
- •Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 except for AEs not constituting a safety risk by Investigator judgement.
排除标准
- •Prior treatment targeting ILT2 and/or ILT4 or targeting HLA-G.
研究组 & 干预措施
NGM707 Combination Cohort A
NGM707 with pembrolizumab in MSS CRC
干预措施: NGM707 plus pembrolizumab (Drug)
结局指标
主要结局
Objective response rate (ORR) as per RECIST v1.1
时间窗: Baseline up to approximately 24 months
Objective Response Rate is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1
Incidence of Adverse Events
时间窗: Baseline up to Approximately 24 Months
Number of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of patients who experience at least one AE will be presented.
次要结局
未报告次要终点