A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors
- Conditions
- Malignant Tumors
- Interventions
- Registration Number
- NCT05516914
- Lead Sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Brief Summary
This trial is an open and multicenter phase Ib/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
- Detailed Description
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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 490
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LBL-007 & Tislelizumab Tislelizumab Injection LBL-007 Injection; dose A or dose B; Q3W LBL-007 & Tislelizumab Gemcitabine Hydrochloride for Injection LBL-007 Injection; dose A or dose B; Q3W LBL-007 & Tislelizumab LBL-007 Injection LBL-007 Injection; dose A or dose B; Q3W LBL-007 & Tislelizumab Cisplatin Injection LBL-007 Injection; dose A or dose B; Q3W LBL-007 & Tislelizumab Docetaxel injection LBL-007 Injection; dose A or dose B; Q3W
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) 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) 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） 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).
- Secondary Outcome Measures
Name Time Method 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) DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD).
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) After taking a single dose, Time to reach maximum plasma concentration
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) To measure duration of response
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) Maximum serum concentration
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) The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects
Trial Locations
- Locations (19)
Sun Yat-Sen Memorial Hospital，Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Huizhou Municipal Central Hospital
🇨🇳Huizhou, Guangdong, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
The Jiangmen Central Hospital
🇨🇳Jiangmen, Guangdong, China
Maoming People's Hospital
🇨🇳Maoming, Guangdong, China
Central People's Hospital of Zhanjinag
🇨🇳Zhanjiang, Guangdong, China
Guangxi Tumour Hospital
🇨🇳Nanning, Guangxi, China
Anhui Cancer Hospital
🇨🇳Hefei, Anhui, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
The First People's Hospital of Yu Lin
🇨🇳Yulin, Guangxi, China
The Second Affiliated Hospital of Hainan Medical University
🇨🇳Haikou, Hainan, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Hangzhou, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science And Technology
🇨🇳Wuhan, Hubei, China
Jiangxi Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China