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

Phase 2RecruitingNCT06343064

Avistone Biotechnology Co., Ltd.156 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

156

Conditions

Non-Small-Cell Lung Cancer

Interventions

VebreltinibDRUG

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.

PLB1004DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Ability to understand and willingness to sign a written informed consent document. 2. Aged at least 18 years old. 3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\~IV). 4. EGFR mutations, including exon 19 deletion and exon 21 L858R. 5. C-Met overexpression and/or c-Met amplification confirmed after treatment with EGFR-TKI. 6. At least one measurable lesion as defined by RECIST V1.1. 7. ECOG performance status 0 to 1. Exclusion Criteria: 1. Previous treatment with MET inhibitors or HGF-targeted therapy. 2. There are mutations of ALK or ROS1. 3. Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control. 4. Pregnant or nursing women.

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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

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

Time frame: 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

Time frame: 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.

Time frame: 3 years

Secondary Outcomes

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

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

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

Central Contacts

Liang Lin

CONTACT

+86-10-84148931 linliang@avistonebio.com

Data from ClinicalTrials.gov

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