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A phase I clinical study evaluating LBL-007 in the treatment of subjects with advanced solid tumors
This trial is a multi-center, single-arm, open-label, dose-escalation and expansion phase I study of LBL-007 combined with Toripalimab and Axitinib in the treatment of unresectable or metastatic melanoma.
It is divided into Study Part A and Study Part B. The safety, tolerability, kinetic characteristics, immunogenicity and preliminary efficacy of the subjects were evaluated. Both study part A and study part B are studied in two phases: dose escalation and dose expansion
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBL-007+Toripalimab+Axitinib Tablets | Experimental | Study Part A： LBL-007 +Toripalimab Study Part B： LBL-007 +Toripalimab +Axitinib Tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBL-007 | Drug | LBL-007 will be administered intravenously every two weeks (Q2W) . |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjcects with adverse events and serious adverse events | The safety profile of LBL-007 and Toripalimab will be assessed by monitoring the adverse event(AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE)v5.0 | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy) |
| 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 two cycles. | During the first two Cycles(each cycle is 14 days) |
| Dose-limiting toxicities (DLT) | DLT is defined as a toxicities(adverse event at least possibly related to LBL-007 and Toripalimab )occurring during the DLT observation period(the initial 28 days). | During the first two Cycles(each cycle is 14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Defined as the percentage of subjects having a Complete Response or Partial Response(ORR, including after immunotherapy complete response (iCR) and partial response (iPR)),will be determined by investigator assessment of radiographic disease assessments per RECIST v1.1. and iRECIST. | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+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 |
|---|---|---|
| Jun Guo, Prof | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| Fujian Cancer Hospital |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D000077784 | Axitinib |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| Toripalimab | Drug | Toripalimab Injection will be administered by intravenously (Q2W) . |
|
| Axitinib Tablets | Drug | Axitinib Tablets On-demand administration |
|
| Duration of Response(DOR) | Defined as the time from earliest date of disease response (CR 、PR、iCR、iPR) until earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1 and iRECIST, or death from any cause, if occurring sooner than progression. | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy) |
| Disease Control Rate(DCR) | Defined as percentage of participants having CR, PR, iCR，iPR or SD as best on-study response | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy) |
| Steady state Area under the serum concentration versus time curve（AUCss） | To determine the PK profile of LBL-007 in combination with Toripalimab | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy) |
| Steady state Maximum serum concentration (Cmax,ss) | To determine the PK profile of LBL-007 in combination with Toripalimab | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy) |
| Steady state Time to reach maximum serum concentration (Tmax,ss) | To determine the PK profile of LBL-007 in combination with Toripalimab | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy) |
| Pharmacodynamic (PD) index | The PD evaluation index is the LAG-3 receptor occupancy rate in peripheral blood | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy) |
| Immunogenicity index | The immunogenicity evaluation indicators are the incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibodies (if applicable) in the subject. | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy) |
| Fuzhou |
| Fujian |
| 350000 |
| China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410006 | China |
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
| Jilin Cancer Hospital | Changchun | Jilin | 130021 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |