Evaluation of LBL-019 Monotherapy or Combined With Anti-PD-1 Antibody in the Treatment of Advanced Malignant Tumors

Advanced Malignant Tumors Clinical Trial

Official title:

A Multicenter, Open Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LBL-019 Monotherapy or Combination Anti-PD-1 Antibody in Patients With Advanced Malignant Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05223231
• Other study ID #: LBL-019-CN001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Advanced Malignant Tumors
• Neoplasms

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