NCT05649761进行中（未招募）1 期
A Phase I, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QL1604, a Humanized Anti-PD-1 Monoclonal Antibody, 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
- 进行中（未招募）
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
This is a first-in-human (FIH), dose-escalation, PK expansion, monotherapy efficacy expansion, and open-label phase I clinical study assessing the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of QL1604 injection （a humanized anti-PD-1 monoclonal antibody）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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
- •Age ≥ 18 years and ≤ 70 years when ICF is signed;
- •Pts with histologically or cytologically confirmed advanced solid tumors;
- •At least one target lesion as defined per RECIST Version (v) 1.1;
- •Subjects who have disease progression or intolerable reactions after the currently available standard anti-cancer treatment previously received or refused prior cancer therapy regimen(s) ;
- •Eastern Cooperative Oncology Group performance status of 0 or 1;
- •Life expectancy of greater than 12 weeks;
- •Adequate hematologic and organ function;
- •Female subjects who are not pregnant or breastfeeding
- •Male and female subjects able to have children must agree to use highly effective method of contraception throughout the study and for at least 120 days after last dose;
排除标准
- •Known hypersensitivity to any monoclonal antibody, QL1604 and/or any of its excipients;
- •Active autoimmune disease that has required systemic treatment, replacement therapy is acceptable;
- •Subjects with major cardiovascular and cerebrovascular diseases;
- •Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug;
- •Subjects who have received surgery, radiotherapy, chemotherapy, targeted therapy, other anti-tumor treatments, or participating in other clinical studies is less than 4 weeks before the first administration of investigational product;
- •Received a live vaccine;
- •Infection with human immunodeficiency virus (HIV);
- •Known psychiatric or substance abuse disorders that would interfere with the requirements of the study;
- •History or current evidence of any condition, therapy, or laboratory abnormality, that might confound the results of the trial, or interfere with the participant's participation for the full duration of the study, or investigators/sponsor consider the subjects are not suitable for this trial.
研究组 & 干预措施
QL1604 injection
Experimental
Participants will receive QL1604 injection 0.3 mg/kg,1mg/kg, 3mg/kg,10mg/kg, or 200mg intravenous every 2 weeks or every 3 weeks and will be continued until disease progression or unacceptable toxicity.
干预措施: QL1604 injection (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Up to 21 days after the first dose
Dose-limiting toxicity (DLT)
maximum tolerated dose(MTD)
时间窗: Up to 21 days after the first dose
maximum tolerated dose(MTD)
recommended phase II dose (RP2D)
时间窗: up to 2 years
recommended phase II dose (RP2D)
次要结局
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs(up to 2 years)
- Maximum Concentration (Cmax) of QL1604 in Solid Tumor Participants(up to 2 years)
- Time to Maximum Concentration (Tmax) of QL1604 in Solid Tumor Participants(up to 2 years)
- Terminal Half-Life (t ½) of QL1604 in Solid Tumor Participants(up to 2 years)
- Area Under the Concentration-Time Curve of QL1604 From Time 0 to Day 28 (AUC 0-22) in Solid Tumor Participants(up to 22 days)
- Objective Response Rate (ORR) According to RECIST 1.1(up to 2 years)
- Disease Control Rate (DCR) According to RECIST 1.1(up to 2 years)
研究者
研究点 (1)
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