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.
This trial includes two phases, Phase Ib and Phase II. Phase Ib is an exploratory stage of safety and efficacy in a single-arm, open-label study, including three cohorts (different dosing regimens).Phase Ib includes three cohorts, Cohort 1 (LBL-024 monotherapy), Cohort 2 (LBL-024 + LBL-007 combination) and Cohort 3 (LBL-024 + toripalimab combination). Phase II includes Part A and Part B.Part A is a randomized, open-label, positive-controlled extension study. It plans to enroll patients with melanoma of the cutaneous, Acral, and unknown primary. Eligible subjects will be randomly assigned in a 2:1 ratio \[Stratification factor: Acral subtype (Yes vs. No)\] to either the Experimental Group or the Control Group. Part B is a single-arm extension study enrolling only patients with mucosal melanoma,and will select a drug combination based on phase Ib efficacy for expansion study. This study requires subjects to provide relevant samples for testing. The trial will enroll up to 200 subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
LBL-024 , Intravenous infusion.
LBL-007 , intravenous infusion.
Toripalimab , intravenous infusion.
Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGSun Yat-sen University Cancer Center
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.
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)
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)
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.
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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Guangzhou, Guangdong, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGGuangxi Medical University Cancer Hospital
Nanning, Guangxi, China
RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGNanjing Drum Tower Hospital
Nanjing, Jiangsu, China
RECRUITINGThe First Hospital of Jilin University
Changchun, Jilin, China
NOT_YET_RECRUITINGShandong Cancer Hospital
Jinan, Shandong, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGShanxi Bethune Hospital
Taiyuan, Shanxi, China
RECRUITING...and 5 more locations
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)
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)