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Study on the Safety and Effects of VERT-002 for Patients with Advanced Solid Tumors, Including Lung Cancer with MET Alterations

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a new treatment for patients with advanced forms of cancer, specifically those with solid tumors that have spread or are difficult to treat. The study includes patients with non-small cell lung cancer that have specific changes in a gene called MET. The treatment being tested is a new drug called VERT-002, which is given through an infusion into the vein.

The purpose of the study is to learn about the safety and effects of VERT-002 in treating these types of cancers. The study is divided into two parts. In the first part, researchers will determine the safest dose of VERT-002 and how well patients tolerate it. In the second part, they will further explore the drug's effects and continue to monitor its safety. The study will help identify the best dose to use in future research.

Participants in the study will receive VERT-002 and will be closely monitored by healthcare professionals. The study will look at how the drug affects the cancer and any side effects that may occur. This research is important for developing new treatments for patients with advanced cancers that have limited options. The study is expected to continue for several years to gather comprehensive data on the drug's effectiveness and safety.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, eligibility is confirmed based on specific criteria such as the presence of certain genetic changes in the tumor and previous treatments received.

    The trial is designed for patients with advanced solid tumors, including lung cancer, with specific genetic changes known as MET alterations.

  2. Step 2

    Part 1: dose escalation

    The initial phase involves determining the safe dosage of the new drug, VERT-002, which is administered through an intravenous infusion.

    The focus is on understanding the safety and how well the body tolerates the drug. This involves monitoring for any side effects and adjusting the dose as needed.

  3. Step 3

    Part 1: safety and tolerability assessment

    During this phase, the occurrence and severity of any side effects are closely monitored. This includes changes in laboratory values, physical examinations, and vital signs.

    The goal is to identify the optimal dose that can be safely administered without causing significant side effects.

  4. Step 4

    Part 2a: preliminary activity examination

    This phase examines the initial effects of VERT-002 on the tumor, assessing its potential to reduce tumor size or slow its growth.

    The drug's impact on the tumor is evaluated using imaging techniques and other assessments.

  5. Step 5

    Part 2b: recommended dose determination

    The focus is on determining the recommended dose for future studies, based on the safety and effectiveness observed in previous phases.

    This involves further monitoring of side effects and the drug's impact on the tumor.

  6. Step 6

    Part 2: overall safety and effectiveness

    The final phase involves a comprehensive assessment of the drug's safety and its ability to control the disease.

    This includes evaluating the overall response rate, progression-free survival, and overall survival of participants.

Who can join the trial?

13 criteria

  • For Part 1, the patient must have a confirmed diagnosis of a relapsed or resistant **locally advanced or metastatic solid tumor** for which no standard treatment is available.
  • The patient must have an **albumin** level of at least 3 grams per deciliter (g/dL). Albumin is a protein in the blood that helps keep fluid in your bloodstream.
  • The patient must have adequate **cardiac function**, meaning their heart is working well enough as defined in the study protocol.
  • For Part 2, the patient must have a confirmed diagnosis of **locally advanced or metastatic non-small cell lung cancer (NSCLC)** at Stage IIIB/C or IV, and they should not be eligible for or should have already received standard treatments like surgery, radiation, or chemotherapy.
  • For Part 1, the patient must have at least one of the following **MET alterations**: METex14 mutation, MET kinase domain activating gene mutations, or MET amplification. These are specific changes in the MET gene that can affect cancer growth.
  • For Part 2-a, the patient must have a METex14 mutation. For Part 2-b, the patient must have at least one of the following MET alterations: METex14 mutation or new MET amplification, confirmed by a tissue sample.
  • For Part 2, the patient must have at least one measurable **target lesion** according to RECIST v1.1, which is a set of guidelines to measure how tumors respond to treatment.
  • The patient must have an **ECOG performance status** of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • For Part 1, the patient may have previously received a **MET TKI** treatment, which is a type of drug that targets the MET gene, regardless of whether it was their first or second treatment.
  • For Part 2, the patient can have had up to 3 previous treatments for their advanced or metastatic disease, which may or may not include prior MET TKI treatment.
  • The patient must have adequate **hematologic function** before the first dose of VERT-002, meaning their blood cells are functioning well enough as defined by the study's laboratory tests.
  • The study is open to both male and female patients.
  • The study includes patients from vulnerable populations, which means it considers those who might need special protection or care.

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another cancer treatment recently.
  • Patients with allergies to the study medication or its ingredients.
  • Patients who are unable to follow the study procedures.
  • Patients with certain heart conditions that could be affected by the study medication.
  • Patients with severe liver or kidney problems.
  • Patients who have participated in another clinical trial recently.
  • Patients with infections that are not well controlled.
  • Patients with a history of drug or alcohol abuse.
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Investigated drugs

VERT-002 is an investigational medication being studied for its potential to treat patients with advanced or metastatic solid tumors, including non-small cell lung cancer that has specific genetic changes known as MET alterations. The trial aims to understand how safe and tolerable this medication is for patients, as well as to find the best dose that can be used in future studies. Researchers are also looking at how well the medication works in shrinking or controlling the tumors.

What is already known about the treatment

VERT-002 – This medication is administered orally and is currently in clinical trials, specifically a phase I/II study, to evaluate its safety and effectiveness. It is being investigated for use in patients with locally advanced or metastatic solid tumors, including non-small cell lung cancer, that have MET alterations. VERT-002 works by targeting and inhibiting the MET receptor, which is involved in the growth and spread of cancer cells. It is classified as a targeted therapy, focusing on specific molecular changes in cancer cells.

Investigated diseases

Locally Advanced or Metastatic Solid Tumors with MET Alterations – This condition involves solid tumors that have either spread to nearby tissues (locally advanced) or to distant parts of the body (metastatic). These tumors have specific changes in the MET gene, which can affect how the cancer grows and spreads. The progression of the disease can vary, with tumors potentially growing larger or spreading to new areas over time. The MET alterations can influence the behavior of the cancer cells, potentially making them more aggressive. The condition is not classified as a rare disease, indicating it occurs with some frequency in the population. Understanding the specific genetic alterations can be crucial for determining potential treatment approaches.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-512760-64-00Protocol codeF60089IV101Estimated enrolment218 patientsSponsorPierre Fabre Medicament

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