NCT04911881已完成1 期
A Phase Ia, Open-Label, Multi-Center, Study of the Safety, Tolerability and Primary Efficacy of IBI321 in Patients With Advanced Solid Tumors
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
- 36
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Adverse Events (AEs), treatment-related AE (TRAE), immune-related AEs (irAE) and serious adverse event (SAE) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 ;
研究概览
简要总结
This first-in-human open-label,dose-escalation study is designed to evaluate the safety, tolerability, and primary efficacy of IBI321 in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
- •Patients with advanced solid tumors who had failed standard treatment.
- •Male or female subjects ≥18 years and ≤75 years.
- •At least one measurable lesion per RECIST version 1.1
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
- •Life expectancy of ≥ 12 weeks.
- •Adequate hematologic and end organ function
排除标准
- •Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, targeted therapy, or immunotherapy.
- •Failure to recover from adverse events from the most recent anti-tumor treatment
- •Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
- •Subjects with CNS metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs.
- •Any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
- •Pregnancy, lactation, breastfeeding
研究组 & 干预措施
Phase Ia Dose-Escalation Stage: IBI321
Experimental
干预措施: IBI321 (Drug)
结局指标
主要结局
Percentage of Participants with Adverse Events (AEs), treatment-related AE (TRAE), immune-related AEs (irAE) and serious adverse event (SAE) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 ;
时间窗: From Day 1 to up to 2 years
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
时间窗: From Day 1 of Cycle 1 to Day 28
次要结局
- Objective Response Rate (ORR)per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.(From Baseline until disease progression (up to 2 years))
- Overall Survival (OS)(From Baseline until disease progression (up to 2 years))
- Percentage of Participants with Anti-Drug Antibodies (ADAs) and Neutralizing Antibody (Nab) to IBI321(From Day 1 up to 2 years)
- Minimum Serum Concentration (Cmin) of IBI321(From Day 1 up to 2 years)
- Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.(From Baseline until disease progression (up to 2 years))
- Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.(From Baseline until disease progression (up to 2 years))
- Maximum Serum Concentration (Cmax) of IBI321(From Day 1 up to 2 years)
- Clearance (CL) of IBI321(From Day 1 up to 2 years)
- Area Under the Concentration-Time Curve (AUC) of IBI321(From Day 1 up to 2 years)
研究者
研究点 (1)
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