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Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI

ConditionNon-Small-Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAvistone Biotechnology Co., Ltd.

About this trial

Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Previous treatment with MET inhibitors or HGF-targeted therapy.

There are mutations of ALK or ROS1.

Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control.

Pregnant or nursing women.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

156 Participants
are divided into 4 treatment groups
Group A: Phase Ib:Vebreltinib 100mg/150mg/200mg BID + PLB1004 80mg/160mg QDExperimental treatment 2 interventions
Group B: Phase II:Cohort 1Experimental treatment 2 interventions
Group C: Phase II:Cohort 2Experimental treatment 2 interventions
Group D: Phase II:Cohort 3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).

In phase Ib，Incidence of Treatment-Emergent Adverse Events (TEAEs),

Time frame
3 years
2

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

Time frame
28 days
3

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.

Time frame
3 years

Secondary outcomes

1

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)

Time frame
From date of first dose up until 28 days post last dose
2

Pharmacokinetics of Vebreltinib and PLB1004: Maximum plasma concentration of the study drug (C-max)

In phase Ib，Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)

Time frame
From date of first dose up until 28 days post last dose
3

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)

Time frame
From date of first dose up until 28 days post last dose
4

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.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Avistone Biotechnology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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