A Phase 1/2 Dose-Finding Study Followed by Expansion Cohorts of NGM120, a GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- To Determine the Safety and Tolerability of NGM120 in Subjects
研究概览
简要总结
Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer (Part 1 and 2) and metastatic castration resistant prostate cancer (Part 3).
详细描述
The aim of the study is to evaluate the safety and tolerability of NGM120 monotherapy in subjects with select advanced solid tumors (Part 1), NGM120 in combination with gemcitabine and Abraxane for the management of metastatic pancreatic cancer (Part 2), and NGM120 in metastatic castration-resistant prostate cancer (mCRPC) patients who have progressed under 1 or more lines of ADT (Part 3), for up to 24 months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part 1 NGM120 100mg
NGM120 100mg Subcutaneous Injection
干预措施: NGM120 100mg (Biological)
Part 1 NGM120 30mg
NGM120 30mg Subcutaneous Injection
干预措施: NGM120 30mg (Biological)
Part 2 NGM120 30mg
NGM120 30mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
干预措施: NGM120 30mg with Gemcitabine and Abraxane (Biological)
Part 2 NGM120 100mg
NGM120 100mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
干预措施: NGM120 100mg with Gemcitabine and Abraxane (Biological)
Part 3 NGM120 100mg Q3W
NGM120 100mg Subcutaneous Injection NGM120 100mg Subcutaneous Injection every 3 weeks
干预措施: NGM120 100mg Q3W (Biological)
Part 2 Placebo
Placebo together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
干预措施: Placebo (Other)
结局指标
主要结局
To Determine the Safety and Tolerability of NGM120 in Subjects
时间窗: From enrollment to end of treatment up to 24 months
Number of Participants with NGM120/Placebo-Related Treatment Emergent Adverse Events
To Determine the Safety and Tolerability of NGM120
时间窗: From enrollment to end of treatment up to 24 months
Local injection-site symptom assessment as evidenced by incidence of injection-site reactions
次要结局
未报告次要终点