A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors
NCT ID: NCT05170958
Last Updated: 2025-05-22
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
396 participants
INTERVENTIONAL
2022-01-06
2026-12-31
Brief Summary
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Detailed Description
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This trial includes two parts:
Part I: A Phase I/IIa clinical study on the safety, tolerability, PK and efficacy of LBL-024 in patients with advanced malignant tumor.
Part II:Phase IIb is a pivotal single-arm clinical study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LBL-024
LBL-024 injection; Initial dose - MTD; Q3W
LBL-024 for Injection
LBL-024 was given every three weeks for treatment
Interventions
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LBL-024 for Injection
LBL-024 was given every three weeks for treatment
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 in the I/IIa trial phase；18-80 years old (including boundary value), no gender limit in the IIb trial phase；
3. Subject has adequate organ and bone marrow function，Conforming to laboratory test results:
4. The expected survival time is at least 12 weeks
5. ECOG score is 0-1
6. 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.
Exclusion Criteria
2. Brain parenchymal metastases or meningeal metastases with clinical symptoms, which are not suitable for inclusion in the group by the investigator's judgment;
3. medical history of immunodeficiency including positive HIV antibody test;
4. Women who are pregnant or breastfeeding;
5. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study
18 Years
80 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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lin Shen
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, China
Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute
Nanning, Guangxi, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Sir Run Run Shaw Hospital
Hangzhou, Hangzhou, China
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Anyang Tumor Hospital
Anyang, Henan, China
The First Affilated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Tongji Hospital
Wuhan, Hubei, China
Wuhan Union Hospital of China
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital Nanchang University
Nanchang, Jiangxi, China
The Ferst Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Ch’ang-ch’un, Jilin, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Cancer Hospital & Institute
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'An Jiaotong University
Xi’an, Shanxi, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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feng
Role: backup
Other Identifiers
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LBL-024-CN001
Identifier Type: -
Identifier Source: org_study_id
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