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This is a single-arm, open-label, multicenter Phase Ib/II clinical study to evaluate the safety, tolerability, PK characteristics, immunogenicity and efficacy of LBL-007 in combination with Toripalimab in Treatment of Advanced Malignant Tumors.
This trial is divided into combination dose escalation phase (Phase Ib) and combination dose expansion phase (Phase II), as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBL-007&Toripalimab | Experimental | LBL-007 Injection; dose A or dose B; Q3W Toripalimab Injection; dose C; Q3W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBL-007 Injection | Drug | LBL-007 Injection; dose A or dose B; Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | According to the evaluation criteria of RECIST V1.1 (solid tumour) or Lugano 2014 (lymphoma),Proportion of subjects achieving complete response (CR) or partial response (PR).It was used to evaluate the efficacy in Phase II | From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy) |
| Dose-limiting toxicities(DLT) | DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.DLT is defined as toxicity (possible adverse events related to LBL-007) during the DLT observation period (3 weeks after the first dose).It was used to evaluate the safety in Phase Ib. | During the first Cycles(each cycle is 21 days) |
| Maximum tolerated dose (MTD) | MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycles. It was used to evaluate the tolerability in Phase Ib . | During the first Cycles(each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjcects with adverse events and serious adverse events | 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-007 and Toripalimab will be assessed by monitoring the Adverse event (AE). | From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| li zhang | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of bengbu medical University | Bengbu | Anhui | 233060 | China | ||
| Chongqing University Three gorges Hospital |
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| Toripalimab Injection | Drug | Toripalimab Injection; dose C; Q3W |
|
|
| 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 (30+7 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 (30+7 days after drug withdrawal or before the start of new anti-tumor therapy) |
| 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 (30+7 days after drug withdrawal or before the start of new anti-tumor therapy) |
| Tmax | 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 (30+7 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 (30+7 days after drug withdrawal or before the start of new anti-tumor therapy) |
| Chongqing |
| Chongqing Municipality |
| 404000 |
| China |
| The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China | Fuzhou | Fujian | 351100 | China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| The First People's Hospital of Yu Lin | Yulin | Guangxi | 537000 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| Changzhou Cancer Hospital | Changzhou | Jiangsu | 213000 | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | China |
| Affiliated Hospital of Jining Medical University | Jining | Shandong | 272007 | China |
| Linyi Cancer Hospital | Linyi | Shandong | 276000 | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | 300202 | China |
| ID | Term |
|---|---|
| C000656314 | toripalimab |
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