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

NCT ID: NCT05223231

Last Updated: 2026-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-19

Study Completion Date

2024-08-09

Brief Summary

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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

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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) .

Conditions

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Advanced Malignant Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LBL-019

singal -arm

Group Type EXPERIMENTAL

LBL-019 Injection

Intervention Type DRUG

initial dose-MTD

anti-PD-1 antibody injection

Intervention Type DRUG

provide medicine base on needs

Interventions

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LBL-019 Injection

initial dose-MTD

Intervention Type DRUG

anti-PD-1 antibody injection

provide medicine base on needs

Intervention Type DRUG

Other Intervention Names

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LBL-019 anti-PD-1 antibody

Eligibility Criteria

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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 timeļ¼›
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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Leads Biolabs Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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caicun zhou

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Shanghai, China

Locations

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Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status

Union hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Hubei Cancer Hospital

Wuhan, Hubei, China

Site Status

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status

The first affiliated hospital with Nanjing medical university

Nanjing, Jiangsu, China

Site Status

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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LBL-019-CN001

Identifier Type: -

Identifier Source: org_study_id

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