This trial is an open-label, multicenter phase Ib/II clinical study to evaluate the efficacy and safety of LBL-024 monotherapy or in combination with albumin-bound paclitaxel in patients with recurrent or metastatic triple negative breast cancer(TNBC).
Agree to follow the trial treatment regimen, visit schedule, laboratory test, and 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.
The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.
The expected survival time is at least 12 weeks.
Use of immunomodulatory drugs within 2 weeks prior to first dose of study drug.
Patients who received live vaccination within 4 weeks before the first dose of study drug or who are scheduled to receive live vaccination during the study treatment period and within 4 weeks after the last dose.
Patients with clinically uncontrolled pleural effusion, peritoneal effusion, or pericardial effusion.
Active infection within 2 weeks prior to first dose of study drug.
Parallel
LBL-024 for Injection
DrugIntravenous infusion.
albumin-bound Paclitaxel injection
DrugIntravenous infusion.
Toripalimab Injection
DrugIntravenous infusion.
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.
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 or LBL-024 Combination Administration will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase Ib study.
Progression-free Survival(PFS)
According to the evaluation criteria of RECIST V1.1 (solid tumour),Time from randomisation 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.
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Nanjing Leads Biolabs Co.,Ltd
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborator
