NCT05119998已完成1 期
A Phase I, Open-label, Multicenter, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI325, an Anti-CD73 Antibody, in Patients With Advanced Solid Tumor
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
- 48
- 试验地点
- 1
- 主要终点
- Number of patients with DLT
研究概览
简要总结
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 in patients with advanced 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed, locally advanced unresectable or metastatic tumors.
- •At least one evaluable or measurable lesion per RECIST 1.1
- •Male or female subject at least 18 years old and no more than 75 years old.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or
- •Must have adequate organ function
- •Be able to provide archived or fresh tumor tissues-
排除标准
- •Previous exposure to any anti-CD73 monoclonal antibody
- •Subjects participating in another interventional clinical study, except for during the survival follow-up phase of the studies.
- •Unstable central nervous system netastases
- •Known active autoimmune disease or inflammatory disease
- •Known active infectious disease
- •Other uncontrolled systematic disease that may increase the risk of participating the study-
研究组 & 干预措施
IBI325 and sintilimab combination does-escalation
Experimental
干预措施: IBI325 + sintilimab (Drug)
IBI325 monotherapy does-escalation
Experimental
干预措施: IBI325 (Drug)
结局指标
主要结局
Number of patients with DLT
时间窗: 28 days post first dose
Number of patients who experienced a dose-limiting toxicity within the first 28 days after the first dose
Number of patients with treatment related AEs
时间窗: Up to 90 days post last dose
Number of patients who experienced a treatment related AEs from the first dose until 90days after the last dose
次要结局
- Positive rate of ADA and Nab(Up to 90 days post last dose)
- The area under the curve (AUC)(Up to 90 days post last dose)
- Maximum concentration (Cmax)(Up to 90 days post last dose)
- Time at which maximum concentration (Tmax)(Up to 90 days post last dose)
- Number of patients with response(Every 6 weeks until progressive disease or up to 24 months after treatment)
- The half-life (t1/2)(Up to 90 days post last dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid TumorAdvanced Solid TumorNCT04162327Innovent Biologics (Suzhou) Co. Ltd.55
Unknown
1 期
A Phase I Study of IBI325 in Patients With Advanced Solid TumorSolid TumorNCT05246995Shandong Cancer Hospital and Institute60
终止
1 期
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung CancersLung CancerOvarian CancerNCT06376253Novartis Pharmaceuticals4
已完成
1 期
A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid TumorsAdvanced Solid Tumors CancerNCT03071757AbbVie139
招募中
1 期
Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 MutationRelapsed or Refractory Acute Myeloid Leukemia (AML)Untreated AMLOther IDH1-mutated Positive Hematologic MalignanciesMyelodysplastic SyndromesNCT02074839Institut de Recherches Internationales Servier291