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To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors
This trial is a single-arm, open-label, phase I/II clinical study of LBL-024 in patients with advanced malignant tumors. The phase I dose escalation and PK expansion phase plans to include patients with advanced malignant tumors who have failed previous standard treatment or do not have standard treatment or are not applicable to standard treatment at this stage. The phase IIa indication expansion phase plans to include patients with advanced malignant tumors , and evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, immunogenicity and preliminary efficacy. Single-arm registry clinical study to be conducted in Phase IIb.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBL-024 | Experimental | LBL-024 injection; Initial dose - MTD; Q3W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBL-024 for Injection | Drug | LBL-024 was given every three weeks for treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | During the dose-escalation phase, the highest dose of dose-limiting toxicity for subjects less than or equal to 1/6 of the study drug within 3 weeks of starting treatment in Phase I study. | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (Visit 30 days after discontinuation of treatment or withdraw from the visit) |
| Dose-limiting toxicities(DLT) | During the DLT observation period, the subject has an event that is reasonably related to the test drug (possibly, likely or definitely related) in Phase I study. | Within 3 weeks after receiving the first dose of the test drug |
| Objective Response Rate (ORR) | Defined as the percentage of subjects having a Complete Response or Partial Response(ORR, including after immunotherapy complete response (iCR) and partial response (iPR)),will be determined by investigator assessment of radiographic disease assessments per RECIST V1.1. It was used to evaluate the efficacy of LBL-024 in Phase II study. | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (Visit 30 days after discontinuation of treatment or withdraw from the visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and serious adverse events | Laboratory examination, physical examination, vital signs and electrocardiogram, etc. | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (Visit 30 days after discontinuation of treatment or withdraw from the visit) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xue kong | Contact | 025-83378099 | kongxue@leadsbiolabs.com |
| Name | Affiliation | Role |
|---|---|---|
| lin Shen | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230000 | China |
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| Maximum serum concentration (Cmax) |
To determine the PK profile of LBL-024 |
| All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (Visit 30 days after discontinuation of treatment or withdraw from the visit) |
| Immunogenicity | Incidence of subjects with anti-drug antibody (ADA) and neutralizing antibody (if applicable) | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (Visit 30 days after discontinuation of treatment or withdraw from the visit) |
| Disease Control Rate(DCR) | Defined as percentage of participants having CR, PR, iCR,iPR or SD as best on-study response | Visit 30 days after discontinuation of treatment or withdraw from the visit |
| Progression-free survival (PFS) | Defined as the time from random assignment in a clinical trial to disease progression or death from any cause, has recently become an endpoint of considerable interest in the study of new oncology drugs. | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal(Visit 30 days after discontinuation of treatment or withdraw from the visit) |
| Anhui Provincial Hospital | Recruiting | Hefei | Anhui | 230002 | China |
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| The Second Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230601 | China |
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| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100005 | China |
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| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Chongqing Cancer Hospital | Recruiting | Chongqing | Chongqing Municipality | 400030 | China |
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| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350000 | China |
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| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350000 | China |
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| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | 361000 | China |
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| The First Affiliated Hospital,Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510062 | China |
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| Sun Yat-sen University Cancer Center | Recruiting | Guanzhou | Guangdong | 510000 | China |
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| Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute | Recruiting | Nanning | Guangxi | 530000 | China |
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| Affiliated Hospital of Zunyi Medical University | Recruiting | Zunyi | Guizhou | 563000 | China |
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| Sir Run Run Shaw Hospital | Recruiting | Hangzhou | Hangzhou | 310000 | China |
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| Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050011 | China |
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| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | 150000 | China |
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| Anyang Tumor Hospital | Recruiting | Anyang | Henan | 455000 | China |
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| The First Affilated Hospital of Henan University of Science & Technology | Recruiting | Luoyang | Henan | 471003 | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | China |
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| Tongji Hospital | Recruiting | Wuhan | Hubei | 430000 | China |
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| Wuhan Union Hospital of China | Recruiting | Wuhan | Hubei | 430000 | China |
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| Hubei Cancer Hospital | Recruiting | Wuhan | Hubei | 430079 | China |
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| Xiangyang Central Hospital | Recruiting | Xiangyang | Hubei | 441000 | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410031 | China |
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| Jiangsu Cancer Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| Nanjing First Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| The Second Affiliated Hospital Nanchang University | Recruiting | Nanchang | Jiangxi | 330000 | China |
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| The Ferst Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
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| The First Hospital of Jilin University | Recruiting | Ch’ang-ch’un | Jilin | 130000 | China |
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| Liaoning Cancer Hospital & Institute | Recruiting | Shenyang | Liaoning | 110000 | China |
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| The First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110000 | China |
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| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250000 | China |
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| Shandong Cancer Hospital & Institute | Recruiting | Jinan | Shandong | 250000 | China |
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| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Shanxi Bethune Hospital | Recruiting | Taiyuan | Shanxi | 030000 | China |
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| Shanxi Provincial Cancer Hospital | Recruiting | Taiyuan | Shanxi | 030000 | China |
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| The First Affiliated Hospital of Xi'An Jiaotong University | Recruiting | Xi’an | Shanxi | 710061 | China |
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| Sichuan Cancer Hospital | Recruiting | Chengdu | Sichuan | 610000 | China |
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| Mianyang Central Hospital | Recruiting | Mianyang | Sichuan | Mianyang | China |
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| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | 300181 | China |
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| Yunnan Cancer Hospital | Recruiting | Kunming | Yunnan | 650000 | China |
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| The Second Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| The First Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310005 | China |
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| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325015 | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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