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Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC
Open label, multicenter Phase Ib/II clinical study to evaluate the safety, efficacy, and pharmacokinetics of Vebreltinib in combination with PLB1004 in patients with locally advanced or metastatic non-small cell lung cancer with MET overexpression or MET amplification following EGFR-TKI treatment failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ib:Vebreltinib 100mg/150mg/200mg BID + PLB1004 80mg/160mg QD | Experimental | In the dose-escalation and dose-expansion phase, patients received oral Vebreltinib 100mg/150mg/200mg BID plus PLB1004 80mg/160mg once daily. |
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| Phase II:Cohort 1 | Experimental | In phase II-Cohort 1:Failed first-generation or second-generation EGFR inhibitors, negative T790M mutation and c-Met amplification(GCN≥6).Patients received oral Vebreltinib（RP2D）plus PLB1004 （RP2D）. |
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| Phase II:Cohort 2 | Experimental | In phase II-Cohort 2 :Failed third-generation EGFR inhibitors, c-Met amplification(GCN≥6).Patients received oral Vebreltinib（RP2D）plus PLB1004 （RP2D）. |
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| Phase II:Cohort 3 | Experimental | In phase II-Cohort 3 :Failed first-generation or second-generation EGFR inhibitors, c-Met over expression.Patients received oral Vebreltinib（RP2D）plus PLB1004 （RP2D）. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vebreltinib | Drug | Phase Ib is a dose escalation study, the initial dose of Vebreltinib is 100mg/150mg/200mg,according to the result of Phase Ib, will confirm the RP2D. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). | In phase Ib，Incidence of Treatment-Emergent Adverse Events (TEAEs), | 3 years |
| Incidence of dose-limiting toxicities (DLT) as defined in the protocol. | In phase Ib，Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol | 28 days |
| Overall Response Rate (ORR） | In phase II,ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Vebreltinib and PLB1004 : Area under the concentration time curve (AUC) | In phase Ib，Measurement of PK parameters: Area under the concentration time curve (AUC) | From date of first dose up until 28 days post last dose |
| Pharmacokinetics of Vebreltinib and PLB1004: Maximum plasma concentration of the study drug (C-max) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Lin | Contact | +86-10-84148931 | linliang@avistonebio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| PLB1004 | Drug | Phase Ib is a dose escalation study, the initial dose of PLB1004 is 80mg/160mg,according to the result of Phase Ib, will confirm the RP2D. |
|
In phase Ib，Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max) |
| From date of first dose up until 28 days post last dose |
| Pharmacokinetics of Vebreltinib and PLB1004: Time to maximum plasma concentration of the study drug (T-max) | In phase Ib，Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max) | From date of first dose up until 28 days post last dose |
| Incidence of Treatment-Emergent Adverse Events | In phase II，Incidence of Treatment-Emergent Adverse Events (TEAEs),A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | 3 years |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |