NCT02216409已完成1 期
A First-in-Human Phase 1 Dose Escalation Trial of Hu5F9-G4 in Patients With Advanced Solid Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 6
- 主要终点
- Safety and Tolerability of Hu5F9-G4
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of Hu5F9-G4 in participants with solid tumors.
详细描述
This is a first-in-human, first-in-class, escalating dose trial of an antibody that inhibits an anti-apoptotic signal in human macrophages. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.
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
- •Patients with histologically or cytologically confirmed advanced solid malignancy or Lymphoma
- •Relapsed or refractory disease after at least 1 prior systemic treatment for the primary malignancy and not a candidate for other curative treatment.
- •Adequate hematologic status
- •Adequate coagulation function
- •Adequate hepatic function
- •Adequate renal function
排除标准
- •Known primary tumors of central nervous system disease
- •Known active brain metastases
- •Known cardiopulmonary disease
研究组 & 干预措施
Treatment (Hu5F9-G4)
Experimental
Hu5F9-G4 monotherapy
干预措施: Hu5F9-G4 (Drug)
结局指标
主要结局
Safety and Tolerability of Hu5F9-G4
时间窗: The first 28 days on study, for determination of Dose Limiting Toxicities
The CTCAE criteria will be used to assess adverse events on this trial.
次要结局
未报告次要终点
研究者
研究点 (6)
Loading locations...
相似试验
终止
1 期
Trial of Magrolimab (Hu5F9-G4) in Combination With Rituximab or Rituximab + Chemotherapy in Participants With Relapsed/Refractory B-cell Non-Hodgkin's LymphomaNon Hodgkin LymphomaNCT02953509Gilead Sciences178
已完成
1 期
Study of Magrolimab (Hu5F9-G4) in Combination With Cetuximab in Participants With Solid Tumors and Advanced Colorectal CancerSolid TumorColorectal CancerNCT02953782Gilead Sciences78
已完成
1 期
A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Following A Single Dose Of PF-04995274 In Healthy Adult VolunteersHealthyNCT01091272Pfizer28
已完成
1 期
IPH5201 as Monotherapy or in Combination With Durvalumab +/- Oleclumab in Subjects With Advanced Solid Tumors.Advanced Solid TumorsNCT04261075MedImmune LLC57
已完成
1 期
Phase 1 Safety, Tolerability, PK & PD Study of AD-214 Administered to Healthy VolunteersInterstitial Lung DiseaseNCT04415671AdAlta Limited50