Phase I/II Study of IVONESCIMAB for Recurrent Glioblastoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06672575

Provider View

This clinical trial is testing a new drug, ivonescimab, to find the best dose and see if it can help control recurrent glioblastoma, a type of brain cancer. The study is divided into two phases: Phase 1 focuses on finding the highest safe dose, and Phase 2 tests if this dose can effectively manage the disease.

Patient Parameters

Program Overview

The study aims to determine the safest and most effective dose of ivonescimab for treating adults with recurrent glioblastoma, a brain cancer that has returned after standard treatment. Researchers will also evaluate how long patients can live without the disease getting worse and the safety of the drug.

Description

This study is divided into two phases. In Phase 1, researchers will find the highest dose of ivonescimab that patients can tolerate. In Phase 2, they will test if this dose can help control glioblastoma that has come back after initial treatment. The main goals are to ensure the drug is safe and to see if it can stop the cancer from progressing for at least six months.

Participants must be adults with a specific type of brain cancer called glioblastoma that has returned after treatment. They will undergo various tests to ensure they are eligible and will be monitored closely throughout the study to track their health and the drug's effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 60 or higher, meaning they can care for themselves but may not be able to work.
  • Have recurrent glioblastoma that has returned after standard treatment, including radiation.
  • Eligible at first or second recurrence of the disease.
  • Must be more than 12 weeks from initial treatment completion, unless a biopsy confirms recurrence earlier.
  • Have a specific type of glioblastoma as per medical criteria.
  • Have measurable disease as per standard criteria.
  • Have a recent MRI scan of the brain.
  • Have adequate organ function based on blood tests.
  • Women of childbearing age must have a negative pregnancy test and agree to use effective contraception.
  • Men must agree to use effective contraception.
  • Must understand and agree to the study requirements and sign a consent form.

Exclusion Criteria

  • Recent major surgery or plans for major surgery soon after starting the study.
  • Currently pregnant or breastfeeding.
  • History of significant bleeding issues or need for blood thinners.
  • Uncontrolled high blood pressure.
  • Taking more than 2mg of dexamethasone daily.
  • History of major heart or vascular diseases.
  • History of severe gastrointestinal issues.
  • History of other serious medical conditions that could affect the study.
  • History of other cancers within the last 3 years, except for certain skin or cervical cancers.
  • Previous treatment with specific cancer drugs or therapies.
  • Known spread of cancer to the brain or other areas outside the brain.
  • Uncontrolled seizures or other significant neurological conditions.
  • History of autoimmune diseases, unless well-controlled.
  • Unable to undergo MRI scans.
  • Recent stroke or mini-stroke.
  • Imaging shows major blood vessel involvement by cancer.

Locations

FACILITYZIPCITYSTATE
The University of Texas M. D. Anderson Cancer Center77030HoustonTexas
The University of Texas MD Anderson Cancer Center77030HoustonTexas

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