A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors

Last updated: May 21, 2025
Sponsor: Nanjing Leads Biolabs Co.,Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

LBL-024 for Injection

Clinical Study ID

NCT05170958
LBL-024-CN001
  • Ages 18-80
  • All Genders

Study Summary

To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Agree to comply with the trial treatment plan and visit plan, voluntarily agree tosign the informed consent form;

  2. 18-75 years old (including boundary value), no gender limit in the I/IIa trialphase;18-80 years old (including boundary value), no gender limit in the IIb trialphase;

  3. Subject has adequate organ and bone marrow function,Conforming to laboratory testresults:

  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 effectivecontraceptive measures From the signing of the informed consent form to within 6months after the last administration of the trial drug (including abstinence,intrauterine device, various hormonal contraception, correct use of contraceptionSets,etc); Women of childbearing age include pre-menopausal women and women within 2years after menopause. Women of childbearing age must have a negative pregnancy testwithin 7 days before the first trial drug is administered.

Exclusion

Exclusion Criteria:

  1. Receiving other unmarketed clinical research drugs or treatments within 4 weeksbefore using the research drug for the first time;

  2. Brain parenchymal metastases or meningeal metastases with clinical symptoms, whichare 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 affectcompliance or are not suitable for participating in the study

Study Design

Total Participants: 396
Treatment Group(s): 1
Primary Treatment: LBL-024 for Injection
Phase: 1/2
Study Start date:
January 06, 2022
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • Anhui Provincial Hospital

    Hefei, Anhui 230002
    China

    Active - Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230000
    China

    Active - Recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui 230601
    China

    Active - Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing 100005
    China

    Active - Recruiting

  • Chongqing Cancer Hospital

    Chongqing, Chongqing 400030
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350000
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350000
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361000
    China

    Active - Recruiting

  • Nanfang Hospital Southern Medical University

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • The First Affiliated Hospital,Sun Yat-sen University

    Guangzhou, Guangdong 510062
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guanzhou, Guangdong 510000
    China

    Active - Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guanzhou, Guangdong 510000
    China

    Site Not Available

  • Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute

    Nanning, Guangxi 530000
    China

    Active - Recruiting

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou 563000
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital

    Hangzhou, Hangzhou 310000
    China

    Active - Recruiting

  • Affiliated Hospital of Hebei University

    Shijiazhuang, Hebei 050031
    China

    Active - Recruiting

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050011
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150000
    China

    Active - Recruiting

  • Anyang Tumor Hospital

    Anyang, Henan 455000
    China

    Active - Recruiting

  • The First Affilated Hospital of Henan University of Science & Technology

    Luoyang, Henan 471003
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei 430079
    China

    Active - Recruiting

  • Tongji Hospital

    Wuhan, Hubei 430000
    China

    Active - Recruiting

  • Wuhan Union Hospital of China

    Wuhan, Hubei 430000
    China

    Active - Recruiting

  • Xiangyang Central Hospital

    Xiangyang, Hubei 441000
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan 410031
    China

    Active - Recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu 210000
    China

    Active - Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

  • Nanjing First Hospital

    Nanjing, Jiangsu 210000
    China

    Active - Recruiting

  • The Ferst Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • The Second Affiliated Hospital Nanchang University

    Nanchang, Jiangxi 330000
    China

    Site Not Available

  • The First Hospital of Jilin University

    Ch'ang-ch'un, Jilin 130000
    China

    Active - Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning 110000
    China

    Active - Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning 110000
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250000
    China

    Active - Recruiting

  • Shandong Cancer Hospital & Institute

    Jinan, Shandong 250000
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi 030000
    China

    Site Not Available

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi 030000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'An Jiaotong University

    Xi'an, Shanxi 710061
    China

    Active - Recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan 610000
    China

    Active - Recruiting

  • Sichuan Cancer Hospital & Institute

    Chengdu, Sichuan 610042
    China

    Active - Recruiting

  • Mianyang Central Hospital

    Mianyang, Sichuan Mianyang
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin 300181
    China

    Active - Recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan 650000
    China

    Active - Recruiting

  • Cancer Hospital of The University of Chinese Academy of Sciences

    Hangzhou, Zhejiang 310022
    China

    Active - Recruiting

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310005
    China

    Active - Recruiting

  • The 1"Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325015
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325015
    China

    Active - Recruiting

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