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Clinical Trials in China / NCT06343064
Recruiting Phase 1/2

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

NCT06343064 · tracked via the Priya Life Science China tracker
Sponsor
Avistone Biotechnology Co., Ltd
Phase
Phase 1/2
Started
2023-06-13
Last updated
2025-05-21

Condition(s) studied

Non-Small-Cell Lung Cancer

Investigational drug(s) / intervention(s)

Vebreltinib →PLB1004 →

Vebreltinib: 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: 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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). — 3 years
    In phase Ib，Incidence of Treatment-Emergent Adverse Events (TEAEs),
  • Incidence of dose-limiting toxicities (DLT) as defined in the protocol. — 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
  • Overall Response Rate (ORR） — 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.

Trial sites (1)

FacilityCityRegionStatus
Shanghai Pulmonary Hospital Shanghai Shanghai Municipality Recruiting

More Avistone Biotechnology Co., Ltd. trials in China

A Study to Evaluate ANS014004 in Subjects With Locally Advanced or Metastatic Solid Tumors Active, not recruiting
Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion. Enrolling by invitation
Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations Recruiting
A Phase Ⅱ Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC) Active, not recruiting
A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors Recruiting

Other trials for the same condition

Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations Recruiting
Combination of Vebreltinib and Osimertinib in Patients with EGFR 21 L858R Mutation Advanced NSCLC Active, not recruiting
SRT Combined With Anlotinib for the Treatment of Brain Metastases From Non-small Cell Lung Cancer Recruiting
Golidocitinib in Combination With Sintilimab for PD-L1 Selected Treatment Locally Advanced or Metastatic Non-Small Cell Lung Cancer(NSCLC) Starting soon
Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion. Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06343064 on ClinicalTrials.gov ↗ ← All trials in China