First-in-Human Trial of VERT-002 for Patients with Advanced Solid Tumors with MET Changes

Sponsor: Pierre Fabre Medicament

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06669117

Provider View

This clinical trial is testing a new drug, VERT-002, to see if it is safe and effective for patients with advanced solid tumors, including non-small cell lung cancer, that have specific changes in the MET gene.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new drug called VERT-002 in patients with advanced solid tumors, such as non-small cell lung cancer, that have specific alterations in the MET gene. Researchers aim to find the safest and most effective dose of VERT-002 for these patients.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced solid tumor that has returned or is resistant to treatment, with no other standard treatment options available.
  • For Part 2, have advanced non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation.
  • Have specific changes in the MET gene, such as METex14 mutation or MET amplification, confirmed by local testing.
  • Have at least one measurable tumor according to standard criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • For Part 1, may have previously received MET Tyrosine Kinase Inhibitor (TKI) treatment.
  • For Part 2, have received no more than two prior lines of systemic therapy.
  • Have adequate blood, liver, and kidney function.
  • Have a blood protein level (albumin) of at least 3 g/dL.
  • Have normal blood clotting and heart function.
  • Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use effective contraception.
  • Men must agree to use contraception to prevent pregnancy in their partners.

Exclusion Criteria

  • Have other targetable gene mutations that can be treated with different drugs.
  • Have had another type of cancer, unless it was treated at least two years ago and there is no evidence of it now.
  • Have uncontrolled brain or spinal cord tumors causing symptoms or needing increasing steroid doses.
  • Have allergies to VERT-002 or similar drugs.
  • Have active infections or tested positive for COVID-19 within two weeks before starting the study.
  • Have significant heart problems or other serious medical conditions.
  • Have a history of lung diseases like interstitial lung disease or radiation pneumonitis.
  • Are pregnant or breastfeeding.
  • Have received MET TKI treatment within seven days before starting the study.
  • Have had other cancer treatments within a certain timeframe before starting the study.
  • Have received a live vaccine within 28 days before starting the study.
  • Have unresolved side effects from previous treatments, except for mild hair loss, fatigue, or mild nerve damage.
  • Have had major surgery within 14 days before starting the study.
  • Have participated in another clinical trial with an investigational drug within a certain timeframe before starting the study.

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