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).
The trial was divided into two phases. Stage I (Phase Ib): Part A: Monotherapy Period:In the phase Ib Part A monotherapy period, a small number of TNBC patients were planned to be enrolled to receive LBL-024 monotherapy.The safety, tolerability, and preliminary efficacy of LBL-024 monotherapy in this population will be assessed by the sponsor and investigator in combination. Part B: Combination Drug Safety Run-In Period:If the safety and tolerability are good and there is preliminary efficacy in Part A,The investigator discussed with the sponsor to decide whether to continue the study in Part B of Phase Ib.Part B is designed to enroll a small number of TNBC patients to receive LBL-024 combination therapy. Stage II (Phase II) : If the safety and tolerability are good and there is preliminary efficacy in the first stage,The investigator discusses with the sponsor to decide whether to continue the co-administration expansion study, continue to enroll TNBC patients, and using a randomized, open, positive control trial design. This study will enroll up to 220 subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Intravenous infusion.
Intravenous infusion.
Intravenous infusion.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGSun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
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.
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
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.
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)
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.
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Cmax
Maximum drug concentration in plasma after administration.
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Tmax
After administration,Time to reach maximum drug concentration in plasma.
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Henan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITINGThe first hospital of Jilin University
Changchun, Jilin, China
RECRUITINGLiaoning Cancer Hospital
Shenyang, Liaoning, China
RECRUITINGTime frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
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.
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Disease Control Rate(DCR)
Percentage of participants achieving CR, PR, iCR, iPR and stable disease (SD) after treatment.
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Duration of Response(DOR)
DOR is defined as the duration from earliest date of disease response (CR、PR 、iCR or iPR) until earliest date of disease progression or death from any cause(if occurring sooner than progression).
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)