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

May 13, 2026 updated by: Nanjing Leads Biolabs Co.,Ltd

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-024 in Patients With Advanced Malignant Tumors

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

396

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • Recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
      • Hefei, Anhui, China, 230002
        • Recruiting
        • Anhui Provincial Hospital
        • Contact:
      • Hefei, Anhui, China, 230000
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 100005
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
          • feng
        • Contact:
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
      • Xiamen, Fujian, China, 361000
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510062
        • Recruiting
        • The First Affiliated Hospital,Sun Yat-Sen University
        • Contact:
      • Guanzhou, Guangdong, China, 510000
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530000
        • Recruiting
        • Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute
        • Contact:
    • Guizhou
      • Zunyi, Guizhou, China, 563000
        • Recruiting
        • Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Hangzhou
      • Hangzhou, Hangzhou, China, 310000
        • Recruiting
        • Sir Run Run Shaw Hospital
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Recruiting
        • Fourth Hospital of Hebei Medical University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Henan
      • Anyang, Henan, China, 455000
        • Recruiting
        • AnYang Tumor Hospital
        • Contact:
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affilated Hospital of Henan University of Science & Technology
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:
      • Wuhan, Hubei, China, 430000
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Wuhan Union Hospital of China
        • Contact:
      • Xiangyang, Hubei, China, 441000
        • Recruiting
        • Xiangyang Central Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410031
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Jiangsu Cancer Hospital
        • Contact:
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing First Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The Ferst Affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, Jiangxi, China, 330000
        • Recruiting
        • The Second Affiliated Hospital Nanchang University
        • Contact:
    • Jilin
      • Ch’ang-ch’un, Jilin, China, 130000
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • Liaoning Cancer Hospital & Institute
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250000
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
      • Jinan, Shandong, China, 250000
        • Recruiting
        • Shandong Cancer Hospital & Institute
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Recruiting
        • Shanxi Provincial Cancer Hospital
        • Contact:
      • Taiyuan, Shanxi, China, 030000
        • Recruiting
        • Shanxi Bethune Hospital
        • Contact:
      • Xi’an, Shanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • Sichuan Cancer Hospital
        • Contact:
      • Mianyang, Sichuan, China, Mianyang
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300181
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • Recruiting
        • Yunnan Cancer Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310005
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • the First Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Wenzhou, Zhejiang, China, 325015
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LBL-024
LBL-024 injection; Initial dose - MTD; Q3W
Drug: LBL-024 for Injection
LBL-024 was given every three weeks for treatment
Other Names:
  • LBL-024

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose (MTD)
Time Frame: 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）
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)
Time Frame: Within 3 weeks after receiving the first dose of the test drug
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)
Time Frame: 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）
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）

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events and serious adverse events
Time Frame: 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）
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）
Maximum serum concentration (Cmax)
Time Frame: 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）
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
Time Frame: 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）
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)
Time Frame: Visit 30 days after discontinuation of treatment or withdraw from the visit
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)
Time Frame: 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）
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）

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Leads Biolabs Co.,Ltd

Investigators

  • Principal Investigator: Lin Shen, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 17, 2021

First Submitted That Met QC Criteria

December 9, 2021

First Posted (Actual)

December 28, 2021

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBL-024-CN001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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