This study is an open-label, multicenter phase Ib/II study to evaluate the efficacy and safety of LBL-024 monotherapy, LBL-024 in combination with LBL-007 or toripalimab in patients with advanced melanoma,To evaluate the preliminary efficacy and safety of LBL-024 monotherapy and combination therapy in patients with advanced melanoma.
Agree to follow the trial treatment regimen, visit schedule,laboratory test, and comply with other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.
At the time of signing the informed consent form, the age was ≥ 18 years old, and the gender was not limited.
The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.
The expected survival time is at least 12 weeks.
Subjects who received live vaccination within 4 weeks before the first dose or were planned to receive live vaccination during the study period and 4 weeks after the dose.
Major surgery or other treatment or diagnosis that has a significant impact on the subject within 4 weeks before the first dose.
Patients with active, or who have had and have the possibility of recurrence of autoimmune diseases.
History of severe cardiovascular and cerebrovascular disorder.
Parallel
LBL-024 for Injection
DrugLBL-024 , Intravenous infusion.
LBL-007 Injection
DrugLBL-007 , intravenous infusion.
Toripalimab Injection
DrugToripalimab , intravenous infusion.
Occurrence of adverse event (AE) and serious adverse event (SAE)
Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-024 monotherapy or combination therapy will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase Ib study.
Objective Response Rate (ORR)
According to the evaluation criteria of RECIST V1.1 (solid tumour) ,Proportion of subjects achieving complete response (CR) or partial response (PR).It was used to evaluate the efficacy in Phase Ib.
Progression-free Survival(PFS)
According to the evaluation criteria of RECIST V1.1 (solid tumour),Time from first dose to disease progression or death from any cause.It was used to evaluate Time of disease no-progression or Drug resistance in Phase II.
Cmax
Maximum drug concentration in plasma after administration.
Tmax
After administration,Time to reach maximum drug concentration in plasma.
Immunogenicity
The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects.Immunogenicity refers to the performance that can elicit an immune response.
Disease Control Rate(DCR)
Percentage of participants achieving CR, PR, iCR, iPR and stable disease (SD) after treatment.
Click on the lead sponsor to view all of their trials.
