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NCT Number: NCT06343064

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

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

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Key information

Conditions

Non-Small-Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location status: Recruiting

Location contact

Caichun Zhou, PHD

CONTACT

[email protected]

+86-21-65115006

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Bozitinib, PLB1001

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.

Primary outcomes

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

    Time frame: 3 years

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

  2. Incidence of dose-limiting toxicities (DLT) as defined in the protocol.

    Time frame: 28 days

    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

  3. Overall Response Rate (ORR）

    Time frame: 3 years

    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.

Secondary outcomes

  1. Pharmacokinetics of Vebreltinib and PLB1004 : Area under the concentration time curve (AUC)

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

    In phase Ib，Measurement of PK parameters: Area under the concentration time curve (AUC)

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

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

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

  3. Pharmacokinetics of Vebreltinib and PLB1004: Time to maximum plasma concentration of the study drug (T-max)

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

    In phase Ib，Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)

  4. Incidence of Treatment-Emergent Adverse Events

    Time frame: 3 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Liang Lin

CONTACT

[email protected]

+86-10-84148931

Sponsors and collaborators

Lead sponsor

Avistone Biotechnology Co., Ltd.

Industry

Registry information

Official study title

A Phase Ib/II Study of Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI

Acronym: KYLIN-1

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2024
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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