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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05170958
• Other study ID #: LBL-024-CN001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 6, 2022
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Nanjing Leads Biolabs Co.,Ltd
• Contact: xiangyu ma
• Phone: 025-83378099-848
• Email: maxy[@]leadsbiolabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 396
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• LBL-024 for Injection
LBL-024 was given every three weeks for treatment

Locations

Country	Name	City	State
China	Anyang Tumor Hospital	Anyang	Henan
China	Beijing Cancer Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Ch'ang-ch'un	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Sichuan Cancer Hospital	Chengdu	Sichuan
China	Chongqing Cancer Hospital	Chongqing	Chongqing
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital,Sun Yat-sen University	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guanzhou	Guangdong
China	Sir Run Run Shaw Hospital	Hangzhou	Hangzhou
China	The First Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Shandong Cancer Hospital & Institute	Jinan	Shandong
China	Yunnan Cancer Hospital	Kunming	Yunnan
China	The First Affilated Hospital of Henan University of Science & Technology	Luoyang	Henan
China	Mianyang Central Hospital	Mianyang	Sichuan
China	The Ferst Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The Second Affiliated Hospital Nanchang University	Nanchang	Jiangxi
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Nanjing First Hospital	Nanjing	Jiangsu
China	Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute	Nanning	Guangxi
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Shanxi Bethune Hospital	Taiyuan	Shanxi
China	Shanxi Provincial Cancer Hospital	Taiyuan	Shanxi
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Tongji Hospital	Wuhan	Hubei
China	Wuhan Union Hospital of China	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'An Jiaotong University	Xi'an	Shanxi
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Xiangyang Central Hospital	Xiangyang	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Leads Biolabs Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)