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VERT-002

Clinical trials are studying VERT-002 in patients with advanced solid tumors, including lung cancer with MET alterations. These studies aim to assess safety, tolerability, dose selection, and early signs of activity in people with cancer.

Table of contents

Trial overview

The clinical trial NCT06669117 studied VERT-002 in patients with advanced solid tumors, including lung cancer with MET alterations. The study was interventional, which means patients received a study treatment so researchers could observe its effects.[1]

The trial status was completed, and it enrolled 48 patients.[1]

Study purposes and endpoints

The main goal in Part 1 was to describe the overall safety and tolerability of VERT-002.[1]

Part 1 also aimed to find the dose range for Part 2 by identifying the optimal biologically active dose (OBD), the maximum tolerated dose (MTD), or the maximum administered dose (MAD) if the MTD could not be reached, along with the dosing schedule.[1]

Part 2a was designed to look for preliminary activity, which means early signs that the treatment may help against the cancer.[1]

Part 2b aimed to determine the Recommended Phase 2 Dose (RP2D) and further describe safety and tolerability.[1]

Who could participate

The study targeted patients with advanced solid tumors, and it specifically included people with lung cancer harboring MET alterations.[1]

This means the trial was not for all cancer types. It focused on a cancer group defined by tumor type and a specific genetic change, which can help researchers study whether the treatment may work in that population.[1]

Study design and trial parts

The trial was divided into multiple parts: Part 1, Part 2a, and Part 2b.[1]

Part 1 focused on finding the best dose range and understanding early safety. Part 2a focused on early activity, and Part 2b focused on the dose that should be used in later studies.[1]

The study data does not name a standard phase such as Phase 1 or Phase 2, but the structure shows an early clinical development program with dose-finding and expansion goals.[1]

What the trial tracked

The trial tracked several important outcomes, including overall safety, tolerability, dose selection, early activity, and the final recommended dose for future study.[1]

  • Safety: whether VERT-002 could be given without unacceptable harm.[1]
  • Tolerability: how well patients could handle the study treatment.[1]
  • Dose finding: choosing the OBD, MTD, or MAD and the schedule for giving the treatment.[1]
  • Preliminary activity: early evidence that the treatment may have anti-cancer effects.[1]
  • RP2D: the dose selected for later-stage research.[1]

Key patient terms

Solid tumors are cancers that form a mass or lump, unlike blood cancers that affect the blood or bone marrow.[1]

MET alterations are changes in a gene-related pathway that can define a specific cancer subgroup in research studies.[1]

Interventional study means the researchers gave a treatment and then measured what happened.[1]

Recommended Phase 2 Dose is the dose chosen to move forward into later testing.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06669117 Part 1 / Part 2a / Part 2b Advanced solid tumors, including lung cancer with MET alterations Completed 48

FAQ

  • What is being studied in VERT-002 clinical trials? The trials are studying VERT-002 in people with advanced solid tumors, including lung cancer with MET alterations. The main goals are to understand safety, tolerability, dose range, and early activity.
  • Who can take part in these trials? The trial includes patients with advanced solid tumors, and it specifically includes lung cancer with MET alterations. Exact eligibility depends on the study rules, which decide who can join.
  • What phase is the VERT-002 trial? The source data does not name a standard phase such as Phase 1 or Phase 2. It does describe Part 1 and Part 2, with Part 2a and Part 2b focused on early activity and the recommended dose.
  • What does the trial want to find out? The trial wants to find the safest and most useful dose range for VERT-002. It also looks at whether the treatment shows early signs of activity against the cancer.
  • Is the VERT-002 study still recruiting? No. The study status is completed. That means the trial has already finished collecting its planned data.

Ongoing Clinical Trials on VERT-002

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

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Spain

Glossary

  • Advanced solid tumors: Cancers that form a lump or mass and have grown beyond an early stage. They may have spread or be harder to treat.
  • Lung cancer: A cancer that starts in the lungs.
  • MET alterations: Changes in the MET gene or related pathway. Trials may study these changes because they can help define a specific cancer group.
  • Safety: How well a treatment can be given without causing unacceptable harm.
  • Tolerability: How well patients can handle a treatment and its effects.
  • Dose: The amount of study treatment given at one time.
  • Optimal biologically active dose (OBD): The dose that appears to have the best useful effect based on biological activity in the study.
  • Maximum tolerated dose (MTD): The highest dose most people can take without too many severe side effects.
  • Maximum administered dose (MAD): The highest dose that was actually given in the trial if the maximum tolerated dose was not reached.
  • Recommended Phase 2 Dose (RP2D): The dose chosen for later studies based on the trial results.
  • Preliminary activity: Early signs that the treatment may help against the cancer.

References