NCT04647838

Tepotinib in Solid Tumors Harboring MET Alterations

A Phase II Study of Tepotinib in Patients With Solid Cancers Harboring c-MET Amplification or Exon 14 Mutation Who Progressed After Standard Treatment for Advanced/Metastatic Disease

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Chungbuk National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to understand efficacy of tepotinib in patients with solid cancers harbouring c-MET amplification or exon 14 mutation who progressed after standard treatment for metastatic disease.

Detailed description

This study is a basket trial with two strata(NSCLC and other cancer). If MET exon 14 skipping mutation or MET amplification(copy number gain ≥6.0 ) is detected by NGS method, then confirmation of genetic findings by Molecular Steering Committee will be followed. Patient can participate in this trial after confirmation of genetic analysis and reviewing other inclusion/exclusion criteria.

Conditions

• Solid Tumor
• MET Exon 14 Skipping Mutation
• MET Amplification

Interventions

Type	Name	Description
DRUG	Tepotinib	Tepotinib 500mg (2 tablets of 250mg) per day D1-21 orally, once daily

Timeline

• Start date: 2020-01-16
• Primary completion: 2023-02-28
• Completion: 2024-08-31
• First posted: 2020-12-01
• Last updated: 2020-12-02

Locations

22 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study