Study on RYZ101 for Treating Worsening or Returning Brain Meningioma

Sponsor: Joshua Palmer

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07150806

Provider View

This clinical trial is testing a new radioactive drug, RYZ101, to see if it is safe and effective in treating brain meningioma that is either getting worse or has come back after treatment. RYZ101 targets specific tumor cells and releases radiation to kill them.

Patient Parameters

Program Overview

The study aims to find out if RYZ101, a radioactive drug, is safe and effective for patients with brain meningioma that is worsening or has returned. RYZ101 works by attaching to a protein on tumor cells and releasing radiation to destroy them. The trial will test the best dose and monitor side effects and effectiveness in shrinking tumors.

Description

The main goal of this study is to see how well RYZ101 works in stopping the growth of brain meningioma over six months. Researchers will also look at how many patients show a positive response to the treatment using brain scans and how long patients live after treatment. They will also check for any side effects during and after the treatment.

Participants will receive RYZ101 through an IV, along with amino acids, every eight weeks for up to four cycles, as long as the disease does not progress or side effects are manageable. Throughout the study, patients will undergo various scans and tests to monitor their health and the treatment's impact.

After completing the treatment, patients will have follow-up visits every three months for a year to check on their progress.

Eligibility Criteria

Inclusion Criteria

  • Adults over 18 years old with worsening or returning brain meningioma.
  • Must have a positive result on a specific PET scan showing the presence of a protein that RYZ101 targets.
  • Must have at least one measurable tumor that is 5 mm or larger.
  • Can have up to three measurable brain tumors.
  • Must be able to undergo regular MRI scans.
  • Must have good kidney function and adequate blood cell counts.
  • Women of childbearing potential must use effective birth control during and after the study.
  • Men must use condoms during and after the study.

Exclusion Criteria

  • Poor overall health or performance status.
  • Recent brain radiation therapy within the last 24 weeks.
  • Allergies to components of the study drug or imaging agents.
  • Previous treatments with certain radioactive therapies.
  • Significant heart disease or uncontrolled high blood pressure.
  • Uncontrolled diabetes or liver cirrhosis.
  • Pregnant or breastfeeding women.
  • Unable to understand or unwilling to sign consent forms.
  • Any condition that may interfere with the study's objectives.

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