To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors
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 in the I/IIa trial phase；18-80 years old (including boundary value), no gender limit in the IIb trial phase；
The expected survival time is at least 12 weeks
ECOG score is 0-1
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;
medical history of immunodeficiency including positive HIV antibody test;
Women who are pregnant or breastfeeding;
Single group
LBL-024 for Injection
DrugLBL-024 was given every three weeks for treatment
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 in Phase I study.
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) in Phase I study.
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 II study.
Adverse events and serious adverse events
Laboratory examination, physical examination, vital signs and electrocardiogram, etc.
Maximum serum concentration (Cmax)
To determine the PK profile of LBL-024
Immunogenicity
Incidence of subjects with anti-drug antibody (ADA) and neutralizing antibody (if applicable)
Disease Control Rate(DCR)
Defined as percentage of participants having CR, PR, iCR，iPR or SD as best on-study response
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