NCT05779163已完成1 期
A Multicenter, Open Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of LBL-033 in the Treatment of Patients With Advanced Malignant 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
- 26
- 试验地点
- 6
- 主要终点
- Dose-limiting toxicities（DLT）
研究概览
简要总结
This trial is an open and multicenter phase I/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
详细描述
This is an open, multicenter Phase I/II clinical trial of LBL-033 in the treatment of patients with advanced malignant tumors，which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
The trial is divided into 2 parts: Phase 1 and Phase 2
Phase I study:
Dose-escalation and PK expansion.The PK expansion study will be judged on the basis of dose escalation data.
Phase II 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form;
- •Age ≥ 18 years old when signing the informed consent form;
- •The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1;
- •The expected survival time is at least 12 weeks;
- •According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable Target lesion;
- •Subject has adequate organ and bone marrow function，Conforming to laboratory test results:
- •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
- •Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
- •Patients with active infection and currently requiring intravenous anti-infective treatment；
- •Those who have clinically uncontrollable pleural effusion, pericardial effusion , requiring repeated drainage or medical intervention;
- •The patient has a Medical history of immunodeficiency, including HIV antibody positive；
- •Women during pregnancy or lactation;
- •The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
研究组 & 干预措施
LBL-033
Experimental
LBL-033 for Injection; Initial dose - MTD; Q2W
干预措施: LBL-033 for Injection (Drug)
结局指标
主要结局
Dose-limiting toxicities（DLT）
时间窗: At the end of Cycle 1（28 days after the first prespecified dose）
DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Maximum tolerated dose (MTD)
时间窗: At the end of Cycle 1（28 days after the first prespecified dose）
MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycles
次要结局
- Cmax(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
- immunogenicity(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
- Duration of Response(DOR）(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
- Objective Response Rate (ORR)(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy.)
- Tmax(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
- Disease Control Rate(DCR）(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
研究者
研究点 (6)
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