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

Study Overview
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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) .

Official Title
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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

Conditions
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Advanced Malignant Tumors

Intervention / Treatment
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* Drug: LBL-019 Injection
* Drug: anti-PD-1 antibody injection


Participation Criteria
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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: 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； 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; Women who are pregnant or breastfeeding; The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LBL-019<br>singal -arm | Drug: LBL-019 Injection<br>* initial dose-MTD<br>* Other names: LBL-019;Drug: anti-PD-1 antibody injection<br>* provide medicine base on needs<br>* Other names: anti-PD-1 antibody;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |