Evaluation of LBL-019 Monotherapy or Combined With Anti-PD-1 Antibody in the Treatment of Advanced Malignant Tumors
NCT ID: NCT05223231
Last Updated: 2026-02-02
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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COMPLETED
PHASE1/PHASE2
26 participants
INTERVENTIONAL
2022-04-19
2024-08-09
Brief Summary
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Detailed Description
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The study was divided into two phases: Phase I (Part A single therapy dose escalation and Part B combination therapy dose escalation) and Phase II (Part A single therapy dose expansion and Part B combination therapy dose expansion) .
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LBL-019
singal -arm
LBL-019 Injection
initial dose-MTD
anti-PD-1 antibody injection
provide medicine base on needs
Interventions
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LBL-019 Injection
initial dose-MTD
anti-PD-1 antibody injection
provide medicine base on needs
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2.18-75 years old (including boundary value), no gender limit;
3\. previous standard treatment failed, no standard treatment or standard treatment is not applicable at this stage;
4.The expected survival time is at least 12 weeks;
Exclusion Criteria
2. Received any other investigational drug or treatment that is not on the market within 4 weeks prior to the initial use of the investigational drug;
3. Women who are pregnant or breastfeeding;
4. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study
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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caicun zhou
Role: PRINCIPAL_INVESTIGATOR
Shanghai Pulmonary Hospital, Shanghai, China
Locations
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Fujian Cancer Hospital
Fuzhou, Fujian, China
Union hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The first affiliated hospital with Nanjing medical university
Nanjing, Jiangsu, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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LBL-019-CN001
Identifier Type: -
Identifier Source: org_study_id
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