RecruitingPhase 1Phase 2NCT06669117

FIH Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors With MET Alterations

A First-In-Human (FIH) Phase I/II Open-label, Multicentre, Dose Escalation and Expansion Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors Including Non-small Cell Lung Cancer (NSCLC) Harboring Mesenchymal-Epithelial Transition (MET) Alterations

Sponsor

Pierre Fabre Medicament

Enrollment

140 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

Solid Tumor MET Alteration

Summary

The goal of this clinical trial is to investigate the safety, the activity of VERT-002 (PFL-002), and the optimal safe dose to be used, in participants with solid tumors including non-small cell lung cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing a new drug called VERT-002 for people with advanced solid tumors or lung cancer that have certain abnormalities in a gene called MET. These MET changes can make cancer cells grow uncontrollably, and VERT-002 is designed to block this pathway. **You may be eligible if...** - You are 18 or older with advanced cancer - Your tumor has a confirmed MET alteration (such as MET exon 14 mutation, MET amplification, or activating MET mutations) - For the lung cancer expansion phase: you have stage IIIB/C or stage IV non-small cell lung cancer - You have measurable disease on scans and have exhausted standard treatment options - You are in good health (ECOG 0–1) **You may NOT be eligible if...** - You cannot provide a tumor tissue sample - You have serious organ dysfunction, active infections, or uncontrolled other conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVERT-002

Route of Administration: Intravenous

Locations(19)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

Gabrail Cancer Research Center

Canton, Ohio, United States

Sarah Cannon Research Institute Oncology Partners

Nashville, Tennessee, United States

Institut Jules Bordet

Anderlecht, Belgium

APHP de Marseille - Hôpital Nord

Marseille, France

Institut de Cancerologie de Ouest (ICO) - Saint-Herblain

Saint-Herblain, France

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, France

Gustave Roussy

Villejuif, France

Universitaet zu Koeln - Centrum fuer Integrierte Onkologie (CIO)

Cologne, Germany

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Azienda Ospedaliero - Universitaria San Luigi Gonzaga

Orbassano, Italy

Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis

Amsterdam, Netherlands

Yonsei University College of Medicine

Seoul, South Korea

Asan Medical Center (AMC)

Seoul, South Korea

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06669117

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