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

January 23, 2024 updated by: Nanjing Leads Biolabs Co.,Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

486

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
    • Hubei
      • Wuhan, Hubei, China, 430079
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Contact:
        • Contact:
    • Hunan
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
    • Shanghai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LBL-019
singal -arm
Drug: LBL-019 Injection
initial dose-MTD
Other Names:
  • LBL-019
Drug: anti-PD-1 antibody injection
provide medicine base on needs
Other Names:
  • anti-PD-1 antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety and tolerability
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 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
All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
immunogenicity
Time Frame: 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;
All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
Pharmacodynamics
Time Frame: 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
All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
ORR
Time Frame: 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
All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
DCR
Time Frame: 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
All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
DOR
Time Frame: 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
All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Leads Biolabs Co.,Ltd

Investigators

  • Principal Investigator: Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2022

Primary Completion (Estimated)

March 22, 2025

Study Completion (Estimated)

October 22, 2025

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

January 24, 2022

First Posted (Actual)

February 3, 2022

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBL-019-CN001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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