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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBL-024 | Experimental | Cohort 1 (LBL-024 monotherapy): Subjects received treatment with LBL-024 , intravenous infusion. |
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| LBL-024 + LBL-007 combination | Experimental | Cohort 2 (LBL-024 + LBL-007 combination): Subjects received treatment with LBL-024 combined with LBL-007 , intravenous infusion. |
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| LBL-024 + toripalimab combination | Experimental | Cohort 3 (LBL-024 + toripalimab combination ): Subjects received treatment with LBL-024 combined with toripalimab , both intravenous infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBL-024 for Injection | Drug | LBL-024 , Intravenous infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum drug concentration in plasma after administration. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Chen | Contact | 025-83378099 | maxy@leadsbiolabs.com |
| Name | Affiliation | Role |
|---|---|---|
| Yu Chen | Fujian Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
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| LBL-007 Injection | Drug | LBL-007 , intravenous infusion. |
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| Toripalimab Injection | Drug | Toripalimab , intravenous infusion. |
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After administration,Time to reach maximum drug concentration in plasma. |
| 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. | 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. | 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). | 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) |
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Dermatology Hospital of Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | 510080 | China |
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| Guangxi Medical University Cancer Hospital | Recruiting | Nanning | Guangxi | 530200 | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430022 | China |
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| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| The First Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130021 | China |
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| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
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| Fudan University Shanghai Cancer Center | Not yet recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Shanxi Bethune Hospital | Recruiting | Taiyuan | Shanxi | 030032 | China |
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| The Second Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi’an | Shanxi | 710004 | China |
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| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
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| Tianjin Medical University Cancer Institute &Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| Yunnan Cancer Hospital | Recruiting | Kunming | Yunnan | 650118 | China |
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| Zhejiang Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310022 | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| C000656314 | toripalimab |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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