A Phase 1 Dose Escalation/Dose Finding Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Number of Patients with Dose-limiting Toxicities
研究概览
简要总结
Study of NGM831 as Monotherapy and in Combination with Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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.
- •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 ILT
- •Prior treatment targeting LAIR1.
研究组 & 干预措施
NGM831 Monotherapy Dose Escalation
Part 1a Single Agent Dose Escalation
干预措施: NGM831 (Drug)
NGM831 combination dose finding with pembrolizumab (KEYTRUDA®)
Part 1b NGM831 plus pembrolizumab (KEYTRUDA®)
干预措施: NGM831 plus pembrolizumab (KEYTRUDA®) (Drug)
NGM831 and NGM438 Combination Dose Finding with pembrolizumab (KEYTRUDA®)
Part 1c NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)
干预措施: NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®) (Drug)
结局指标
主要结局
Number of Patients with Dose-limiting Toxicities
时间窗: Baseline up to 21 Days
A DLT is defined as an AE that meets at least one of the criteria listed in protocol, according to National Cancer Institute (NCI) common terminology criteria for AE (CTCAE) version 5.0 and is considered by the Investigator to be clinically relevant and attributed to the study treatment during the first 21 days after the first dose of study treatment.
Incidence of Adverse Events
时间窗: Baseline up to Approximately 24 months
Number of patients with treatment-emergent adverse events (AEs) 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
- Maximum Observed Serum Concentration (Cmax) of NGM831(Baseline up to approximately 9 weeks)
- Time to Maximum Observed Serum Concentration (Tmax) of NGM831(Baseline up to approximately 9 weeks)
- Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM831(Baseline up to approximately 9 weeks)
- Maximum Observed Serum Concentration (Cmax) of NGM438(Baseline up to approximately 9 weeks)
- Time to Maximum Observed Serum Concentration (Tmax) of NGM438.(Baseline up to approximately 9 weeks)
- Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM438(Baseline up to approximately 9 weeks)
- Anti-drug Antibodies (ADA) Against NGM831(Baseline up to approximately 24 months)
- Anti-drug Antibodies (ADA) Against NGM438(Baseline up to approximately 24 months)
- Neutralizing antibodies (nAb) against NGM831(Baseline up to approximately 24 months)
- Neutralizing antibodies (nAb) against NGM438(Baseline up to approximately 24 months)
- Number of Patients with Objective Responses(Baseline up to approximately 24 months)