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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05223231
Other study ID # LBL-019-CN001
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date February 24, 2022
Est. completion date October 22, 2025

Study information

Verified date January 2024
Source Nanjing Leads Biolabs Co.,Ltd
Contact ling zang
Phone 025-83378099-842
Email zangling@leadsbiolabs.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is a phase I/II study, which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors.


Description:

This trial is a phase I/II study , which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors. Approximately 244-486 subjects with advanced malignant tumors will be enrolled. The study was divided into two phases: Phase I (Part A single therapy dose escalation and Part B combination therapy dose escalation) and Phase II (Part A single therapy dose expansion and Part B combination therapy dose expansion) .


Recruitment information / eligibility

Status Recruiting
Enrollment 486
Est. completion date October 22, 2025
Est. primary completion date March 22, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 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; 3. previous standard treatment failed, no standard treatment or standard treatment is not applicable at this stage; 4.The expected survival time is at least 12 weeks; Exclusion Criteria: 1. Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before using the study drug for the first time; 2. Received any other investigational drug or treatment that is not on the market within 4 weeks prior to the initial use of the investigational drug; 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
LBL-019 Injection
initial dose-MTD
anti-PD-1 antibody injection
provide medicine base on needs

Locations

Country Name City State
China Hunan Cancer Hospital Changsha Hunan
China Fujian Cancer Hospital Fuzhou Fujian
China The first affiliated hospital with Nanjing medical university Nanjing Jiangsu
China Shanghai Pulmonary Hospital Shanghai Shanghai
China Hubei Cancer Hospital Wuhan Hubei
China Union hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei

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 safety and tolerability To evaluate the safety, tolerability of LBL-019 monotherapy or combined with anti-PD-1 antibody, which is according to the number of DLT and the number of treatment related AES All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
Secondary Cmax Maximum serum concentration All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
Secondary immunogenicity The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects; All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
Secondary Pharmacodynamics Receptor occupancy All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
Secondary ORR Objective Response Rate All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
Secondary DCR Disease Control Rate All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
Secondary DOR To measure duration of response All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
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