Study on VT3989 for Patients with Metastatic Solid Tumors with NF2 Gene Mutations

Sponsor: Vivace Therapeutics, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04665206

Provider View

This clinical trial is testing a new drug, VT3989, to see if it is safe and effective for patients with metastatic solid tumors or mesothelioma, especially those with NF2 gene mutations, who have not responded to standard treatments.

Patient Parameters

Program Overview

The study aims to find out if VT3989, taken once daily in cycles of 3 or 4 weeks, is safe and can help treat patients with mesothelioma or metastatic solid tumors that have not responded to other treatments. The trial will start by testing different doses to find the safest and most effective one, and then expand to see how well it works in different groups of patients.

Description

The trial will begin with a dose escalation phase, where small groups of patients will receive increasing doses of VT3989 to determine the highest dose that can be given safely. This phase will help identify the recommended dose for further testing. Once the safe dose is established, the study will expand to include more patients to evaluate the drug's effectiveness in reducing tumors. There will be several groups in this phase, including patients with mesothelioma and those with solid tumors that have specific genetic changes, such as NF2 mutations or YAP/TAZ gene rearrangements. The study will use specific criteria to measure the tumors and assess the drug's impact.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with metastatic solid tumor or mesothelioma that has worsened after all available treatments, unless the patient is not a candidate for or refuses such treatments.
  • For mesothelioma patients, the cancer can have NF2 mutations or not.
  • For solid tumor patients, the cancer must have specific NF2 mutations or YAP/TAZ gene changes.
  • The cancer must be measurable by standard criteria.
  • Patients must be in good overall health, with a performance status score of 0 or 1.

Exclusion Criteria

  • Have active cancer spread to the brain or primary brain tumors.
  • Have a history of cancer spread to the membranes covering the brain and spinal cord.
  • Have active or uncontrolled infections requiring treatment.
  • Be HIV positive or have active Hepatitis B or C.
  • Have significant heart disease.
  • Have another active cancer that could interfere with the study results.
  • Be pregnant or breastfeeding.
  • Have previously been treated with a TEAD inhibitor.

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