A Multicenter, Open Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LBL-019 Monotherapy or Combination Anti-PD-1 Antibody in Patients With Advanced Malignant Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 6
- 主要终点
- safety and tolerability
研究概览
简要总结
This trial is a phase I/II study, which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors.
详细描述
This trial is a phase I/II study , which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors. Approximately 244-486 subjects with advanced malignant tumors will be enrolled.
The study was divided into two phases: Phase I (Part A single therapy dose escalation and Part B combination therapy dose escalation) and Phase II (Part A single therapy dose expansion and Part B combination therapy dose expansion) .
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;
- •2.18-75 years old (including boundary value), no gender limit;
- •3. previous standard treatment failed, no standard treatment or standard treatment is not applicable at this stage;
- •4.The expected survival time is at least 12 weeks;
排除标准
- •Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before using the study drug for the first time；
- •Received any other investigational drug or treatment that is not on the market within 4 weeks prior to the initial use of the investigational drug;
- •Women who are pregnant or breastfeeding;
- •The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study
研究组 & 干预措施
LBL-019
singal -arm
干预措施: LBL-019 Injection (Drug)
LBL-019
singal -arm
干预措施: anti-PD-1 antibody injection (Drug)
结局指标
主要结局
safety and tolerability
时间窗: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
To evaluate the safety, tolerability of LBL-019 monotherapy or combined with anti-PD-1 antibody, which is according to the number of DLT and the number of treatment related AES
次要结局
- DOR(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months)
- Cmax(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months)
- immunogenicity(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months)
- Pharmacodynamics(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months)
- ORR(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months)
- DCR(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months)