A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors

Study Overview
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Brief Summary
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To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors

Detailed Description
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This trial is a single-arm, open-label, phase I/II clinical study of LBL-024 in patients with advanced malignant tumors. The phase I dose escalation and PK expansion phase plans to include patients with advanced malignant tumors who have failed previous standard treatment or do not have standard treatment or are not applicable to standard treatment at this stage. The phase II indication expansion phase plans to include patients with advanced malignant tumors , and evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, immunogenicity and preliminary efficacy. This trial includes two parts: phase I study phase and phase II study phase.

Official Title
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A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-024 in Patients With Advanced Malignant Tumors

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: LBL-024 for Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form; 18-75 years old (including boundary value), no gender limit; Subject has adequate organ and bone marrow function，Conforming to laboratory test results: The expected survival time is at least 12 weeks Males with fertility and females of childbearing age are willing to take effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets，etc）; Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered. Exclusion Criteria: Receiving other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time; Brain parenchymal metastases or meningeal metastases with clinical symptoms, which are not suitable for inclusion in the group by the investigator's judgment; 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-024<br>LBL-024 injection; Initial dose - MTD; Q3W | Drug: LBL-024 for Injection<br>* LBL-024 was given every three weeks for treatment<br>* Other names: LBL-024;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose (MTD) | During the dose-escalation phase, the highest dose of dose-limiting toxicity for subjects less than or equal to 1/6 of the study drug within 3 weeks of starting treatment | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit） | 
| Dose-limiting toxicities（DLT) | During the DLT observation period, the subject has an event that is reasonably related to the test drug (possibly, likely or definitely related) | Within 3 weeks after receiving the first dose of the test drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and serious adverse events | Laboratory examination, physical examination, vital signs and electrocardiogram, etc. | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit） | 
| Maximum serum concentration (Cmax) | To determine the PK profile of LBL-024 | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit） | 
| Immunogenicity | Incidence of subjects with anti-drug antibody (ADA) and neutralizing antibody (if applicable) | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit） | 
| Objective Response Rate (ORR) | Defined as the percentage of subjects having a Complete Response or Partial Response(ORR, including after immunotherapy complete response (iCR) and partial response (iPR)),will be determined by investigator assessment of radiographic disease assessments per RECIST V1.1. It was used to evaluate the efficacy of LBL-024 in Phase I study | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit） | 
| Disease Control Rate(DCR) | Defined as percentage of participants having CR, PR, iCR，iPR or SD as best on-study response | Visit 30 days after discontinuation of treatment or withdraw from the visit |