A Phase Ib/II Study of Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Ability to understand and willingness to sign a written informed consent document.
• Aged at least 18 years old.
• Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\
⁃ IV).
• EGFR mutations, including exon 19 deletion and exon 21 L858R.
• C-Met overexpression and/or c-Met amplification confirmed after treatment with EGFR-TKI.
• At least one measurable lesion as defined by RECIST V1.1.
• ECOG performance status 0 to 1.
Locations
Other Locations
China
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
Contact Information
Primary
Liang Lin
linliang@avistonebio.com
+86-10-84148931
Time Frame
Start Date: 2023-06-13
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 156
Treatments
Experimental: Phase Ib:Vebreltinib 100mg/150mg/200mg BID + PLB1004 80mg/160mg QD
In the dose-escalation and dose-expansion phase, patients received oral Vebreltinib 100mg/150mg/200mg BID plus PLB1004 80mg/160mg once daily.
Experimental: Phase II:Cohort 1
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）.
Experimental: Phase II:Cohort 2
In phase II-Cohort 2 :Failed third-generation EGFR inhibitors, c-Met amplification(GCN≥6).Patients received oral Vebreltinib（RP2D）plus PLB1004 （RP2D）.
Experimental: Phase II:Cohort 3
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）.
Related Therapeutic Areas
Sponsors
Leads: Avistone Biotechnology Co., Ltd.