A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors
NCT ID: NCT05516914
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
490 participants
INTERVENTIONAL
2022-09-01
2026-07-30
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LBL-007 & Tislelizumab
LBL-007 Injection; dose A or dose B; Q3W
LBL-007 Injection
Initial dose - MTD; Q3W; intravenous infusion
Tislelizumab Injection
Initial dose; Q3W; intravenous infusion
Cisplatin Injection
Initial dose；Q3W; intravenous infusion
Gemcitabine Hydrochloride for Injection
Initial dose；Q3W; intravenous infusion
Docetaxel injection
Initial dose；Q3W; intravenous infusion
Interventions
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LBL-007 Injection
Initial dose - MTD; Q3W; intravenous infusion
Tislelizumab Injection
Initial dose; Q3W; intravenous infusion
Cisplatin Injection
Initial dose；Q3W; intravenous infusion
Gemcitabine Hydrochloride for Injection
Initial dose；Q3W; intravenous infusion
Docetaxel injection
Initial dose；Q3W; intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 and ≤ 75 years old when signing the informed consent form, regardless of gender;
3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) PS is 0\~1;
4. The expected survival time is at least 12 weeks;
5. According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), the subjects enrolled have at least one measurable tumor lesion;
6. Subject has adequate organ and bone marrow function
7. 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.
Exclusion Criteria
2. Those who have clinically uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage or medical intervention;
3. Women during pregnancy or lactation;
4. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
5. Patients with history of severe cardiovascular and cerebrovascular diseases.
6. Patients with active infection and currently requiring intravenous anti-infective treatment
18 Years
75 Years
ALL
No
Sponsors
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Nanjing Leads Biolabs Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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li zhang
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Anhui Cancer Hospital
Hefei, Anhui, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital，Sun Yat-Sen University
Guangzhou, Guangdong, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, 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
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
Hubei Cancer Hospital
Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science And Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LBL-007-CN-004
Identifier Type: -
Identifier Source: org_study_id
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