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

March 29, 2024 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 II indication expansion phase plans to include patients with advanced malignant tumors , and evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, immunogenicity and preliminary efficacy.

This trial includes two parts: phase I study phase and phase II study phase.

Study Type

Interventional

Enrollment (Estimated)

370

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
        • Not yet recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100005
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, Beijing, China, 100142
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400030
    • Fujian
      • Fuzhou, Fujian, China, 350000
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • Fujian cancer hospital
        • Contact:
      • Xiamen, Fujian, China, 361000
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510062
        • Recruiting
        • The First Affiliated Hospital,Sun Yat-sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510000
      • Guanzhou, Guangdong, China, 510000
      • Guanzhou, Guangdong, China, 510000
        • Not yet recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530000
        • Not yet recruiting
        • Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute
        • Contact:
        • Contact:
    • Guizhou
      • Zunyi, Guizhou, China, 563000
    • Hangzhou
      • Hangzhou, Hangzhou, China, 310000
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Recruiting
        • Fourth Hospital of Hebei Medical University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
    • Henan
      • Anyang, Henan, China, 455000
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affilated Hospital of Henan University of Science & Technology
        • Contact:
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
      • Zhengzhou, Henan, China, 450000
      • Zhengzhou, Henan, China, 450003
    • Hubei
      • Wuhan, Hubei, China, 430079
      • Wuhan, Hubei, China, 430000
      • Wuhan, Hubei, China, 430000
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Wuhan Union Hospital of China
        • Contact:
      • Xiangyang, Hubei, China, 441000
    • Hunan
      • Changsha, Hunan, China, 410031
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
      • Nanjing, Jiangsu, China, 210000
      • Nanjing, Jiangsu, China, 210000
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The Ferst Affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, Jiangxi, China, 330000
        • Not yet recruiting
        • The Second Affiliated Hospital Nanchang University
        • Contact:
        • Contact:
    • Jilin
      • Ch'ang-ch'un, Jilin, China, 130000
    • Liaoning
      • Shenyang, Liaoning, China, 110000
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • Liaoning cancer Hospital & Institute
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250000
      • Jinan, Shandong, China, 250000
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
      • Taiyuan, Shanxi, China, 030000
      • Xi'an, Shanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'An JiaoTong University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610042
        • Recruiting
        • Sichuan Cancer Hospital & Institute
        • Contact:
      • Chengdu, Sichuan, China, 610000
    • Tianjin
      • Tianjin, Tianjin, China, 300181
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
      • Tianjin, Tianjin, China, 300000
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650000
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310005
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
        • Contact:
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
        • Contact:
      • Wenzhou, Zhejiang, China, 325000
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
        • Contact:
      • Wenzhou, Zhejiang, China, 325015
        • Recruiting
        • The 1"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;
  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. 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. 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

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
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)
Within 3 weeks after receiving the first dose of the test drug

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
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 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）

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)

July 1, 2024

Study Completion (Estimated)

January 1, 2025

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)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

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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