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

NCT05170958 | Recruiting Phase 1 DMC

• 1 other identifier: LBL-024-CN001
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 49

Brief Summary

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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）

Secondary Outcomes (5)

• Adverse events and serious adverse events

  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)

  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

  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)

  Visit 30 days after discontinuation of treatment or withdraw from the visit

• Progression-free survival (PFS)

  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）

Study Arms (1)

LBL-024

EXPERIMENTAL

LBL-024 injection; Initial dose - MTD; Q3W

Drug: LBL-024 for Injection

Interventions

LBL-024 for Injection DRUG

LBL-024 was given every three weeks for treatment

Also known as: LBL-024

LBL-024

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;
• 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；
• Subject has adequate organ and bone marrow function，Conforming to laboratory test results:
• The expected survival time is at least 12 weeks
• ECOG score is 0-1
• 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.

You may not qualify if:

• Receiving other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
• medical history of immunodeficiency including positive HIV antibody test;
• Women who are pregnant or breastfeeding;
• The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study

Sponsors & Collaborators

• Nanjing Leads Biolabs Co.,Ltd: lead

Study Sites (49)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

RECRUITING

Anhui Provincial Hospital

Hefei, Anhui, 230002, China

RECRUITING

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

NOT YET RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, 510062, China

RECRUITING

Sun Yat-sen University Cancer Center

Guanzhou, Guangdong, 510000, China

RECRUITING

Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute

Nanning, Guangxi, 530000, China

RECRUITING

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

RECRUITING

Sir Run Run Shaw Hospital

Hangzhou, Hangzhou, 310000, China

RECRUITING

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

RECRUITING

Anyang Tumor Hospital

Anyang, Henan, 455000, China

RECRUITING

The First Affilated Hospital of Henan University of Science & Technology

Luoyang, Henan, 471003, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

RECRUITING

Tongji Hospital

Wuhan, Hubei, 430000, China

RECRUITING

Wuhan Union Hospital of China

Wuhan, Hubei, 430000, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

RECRUITING

Xiangyang Central Hospital

Xiangyang, Hubei, 441000, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

RECRUITING

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

The Second Affiliated Hospital Nanchang University

Nanchang, Jiangxi, 330000, China

NOT YET RECRUITING

The Ferst Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

The First Hospital of Jilin University

Ch’ang-ch’un, Jilin, 130000, China

RECRUITING

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110000, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110000, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

RECRUITING

Shandong Cancer Hospital & Institute

Jinan, Shandong, 250000, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030000, China

NOT YET RECRUITING

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, 030000, China

RECRUITING

The First Affiliated Hospital of Xi'An Jiaotong University

Xi’an, Shanxi, 710061, China

RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuan, 610000, China

RECRUITING

Mianyang Central Hospital

Mianyang, Sichuan, Mianyang, China

NOT YET RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300181, China

RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, 650000, China

RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310005, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325015, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• lin Shen

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiangyu ma

CONTACT

025-83378099-848; maxy@leadsbiolabs.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 28, 2021
• Study Start: January 6, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (49)