A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-024 in Patients With Advanced Malignant Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 396
- 试验地点
- 49
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors
详细描述
This trial is a single-arm, open-label, phase I/II clinical study of LBL-024 in patients with advanced malignant tumors. The phase I dose escalation and PK expansion phase plans to include patients with advanced malignant tumors who have failed previous standard treatment or do not have standard treatment or are not applicable to standard treatment at this stage. The phase IIa indication expansion phase plans to include patients with advanced malignant tumors , and evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, immunogenicity and preliminary efficacy. Single-arm registry clinical study to be conducted in Phase IIb.
This trial includes two parts:
Part I: A Phase I/IIa clinical study on the safety, tolerability, PK and efficacy of LBL-024 in patients with advanced malignant tumor.
Part II:Phase IIb is a pivotal single-arm clinical study.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;
- •18-75 years old (including boundary value), no gender limit in the I/IIa trial phase；18-80 years old (including boundary value), no gender limit in the IIb trial phase；
- •Subject has adequate organ and bone marrow function，Conforming to laboratory test results:
- •The expected survival time is at least 12 weeks
- •ECOG score is 0-1
- •Males with fertility and females of childbearing age are willing to take effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets，etc）; Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.
排除标准
- •Receiving other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
- •Brain parenchymal metastases or meningeal metastases with clinical symptoms, which are not suitable for inclusion in the group by the investigator's judgment;
- •medical history of immunodeficiency including positive HIV antibody test;
- •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-024
LBL-024 injection; Initial dose - MTD; Q3W
干预措施: LBL-024 for Injection (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）
During the dose-escalation phase, the highest dose of dose-limiting toxicity for subjects less than or equal to 1/6 of the study drug within 3 weeks of starting treatment in Phase I study.
Objective Response Rate (ORR)
时间窗: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）
Defined as the percentage of subjects having a Complete Response or Partial Response(ORR, including after immunotherapy complete response (iCR) and partial response (iPR)),will be determined by investigator assessment of radiographic disease assessments per RECIST V1.1. It was used to evaluate the efficacy of LBL-024 in Phase II study.
Dose-limiting toxicities（DLT)
时间窗: Within 3 weeks after receiving the first dose of the test drug
During the DLT observation period, the subject has an event that is reasonably related to the test drug (possibly, likely or definitely related) in Phase I study.
次要结局
- Adverse events and serious adverse events(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）)
- Disease Control Rate(DCR)(Visit 30 days after discontinuation of treatment or withdraw from the visit)
- Progression-free survival (PFS)(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal（Visit 30 days after discontinuation of treatment or withdraw from the visit）)
- Immunogenicity(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）)
- Maximum serum concentration (Cmax)(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）)