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

Phase 1

Recruiting

• Conditions: Advanced Malignant Tumors
• Interventions: Drug: LBL-019 Injection; Drug: anti-PD-1 antibody injection

• Registration Number: NCT05223231
• Lead Sponsor: Nanjing Leads Biolabs Co.,Ltd

Brief 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.

Detailed 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) .

Study Timeline

• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-01-24
• Study First Posted: 2022-02-03
• Study Start: 2022-02-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-10-22
• Study Completion: 2025-10-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 486

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LBL-019	anti-PD-1 antibody injection	singal -arm
LBL-019	LBL-019 Injection	singal -arm

Primary Outcome Measures

Name	Time	Method
safety and tolerability	All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months	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

Secondary Outcome Measures

Name	Time	Method
DOR	All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months	To measure duration of response
Cmax	All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months	Maximum serum concentration
immunogenicity	All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months	The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects;
Pharmacodynamics	All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months	Receptor occupancy
ORR	All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months	Objective Response Rate
DCR	All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months	Disease Control Rate

Trial Locations

Locations (6)

Union hospital Tongji Medical College Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Hubei Cancer Hospital; 🇨🇳 Wuhan, Hubei, China

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

The first affiliated hospital with Nanjing medical university; 🇨🇳 Nanjing, Jiangsu, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China