A Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LBL-007 in Combination With Tislelizumab in the Treatment of Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 19
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This trial is an open and multicenter phase Ib/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 Ib/II clinical trial of LBL-007 combined with Tislelizumab in the treatment of malignant tumors，which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
The study was divided into two phases: Phase Ib (Part A): Dose escalation and PK expansion; Phase II includes: Part B, Part C, Part D, Part E, Part F, Part G, Part H. Part B ~ Part H will be designed and conducted based on the safety , tolerability and PK analysis of the Part A Study Part, after RP2D is determined, will be used for Part B ~ Part H cohort. Approximately 250-490 subjects will be enrolled (Specific sample size shall be subject to actual occurrence)
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
- •Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form;
- •Age ≥ 18 and ≤ 75 years old when signing the informed consent form, regardless of gender;
- •The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) PS is 0~1;
- •The expected survival time is at least 12 weeks;
- •According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), the subjects enrolled have at least one measurable tumor lesion;
- •Subject has adequate organ and bone marrow function
- •Males with fertility and females of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception from the signing of the informed consent form to 6 months after the last administration of the trial drug 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;
- •Those who have clinically uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage or medical intervention;
- •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.
- •Patients with history of severe cardiovascular and cerebrovascular diseases.
- •Patients with active infection and currently requiring intravenous anti-infective treatment
研究组 & 干预措施
LBL-007 & Tislelizumab
LBL-007 Injection; dose A or dose B; Q3W
干预措施: Docetaxel injection (Drug)
LBL-007 & Tislelizumab
LBL-007 Injection; dose A or dose B; Q3W
干预措施: LBL-007 Injection (Drug)
LBL-007 & Tislelizumab
LBL-007 Injection; dose A or dose B; Q3W
干预措施: Tislelizumab Injection (Drug)
LBL-007 & Tislelizumab
LBL-007 Injection; dose A or dose B; Q3W
干预措施: Cisplatin Injection (Drug)
LBL-007 & Tislelizumab
LBL-007 Injection; dose A or dose B; Q3W
干预措施: Gemcitabine Hydrochloride for Injection (Drug)
结局指标
主要结局
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 (30+7 days after drug withdrawal or before the start of new anti-tumor therapy
ORR (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), refers to the percentage of study subjects who achieve a complete response or partial response
Maximum tolerated dose (MTD)
时间窗: At the end of Cycle 1 (each cycle is 21days)
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
Dose-limiting toxicities（DLT）
时间窗: DLT is defined as toxicity during the DLT observation period. The duration of DLT observation period is from the first dose to 3 weeks after the first dose
DLT is defined as toxicity during the DLT observation period (3 weeks after the first dose).
次要结局
- Disease Control Rate(DCR)(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy))
- Tmax(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy))
- Duration of Response(DOR)(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy))
- Cmax(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy))
- immunogenicity(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy))