Study on Temozolomide, With or Without WSD0922-FU, for Treating EGFR-Mutant, IDH-Wildtype Glioblastoma

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT07708961

This clinical trial is testing whether adding a new drug, WSD0922-FU, to the standard treatment with temozolomide can better slow down the progression of glioblastoma, a type of brain cancer, in patients with specific genetic markers.

Patient Parameters

Program Overview

This study is exploring if combining a new drug, WSD0922-FU, with the standard chemotherapy drug temozolomide can more effectively slow down the growth of glioblastoma tumors in patients with specific genetic characteristics. Temozolomide works by damaging the DNA of cancer cells, while WSD0922-FU targets a protein called EGFR, which is involved in tumor growth. The study aims to see if this combination can improve outcomes for patients with EGFR-mutant, IDH-wildtype glioblastoma compared to using temozolomide alone.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of glioblastoma with specific genetic markers (EGFR mutation and IDH-wildtype).
  • Must have completed standard radiation therapy with temozolomide and recovered from any side effects.
  • Must not have started additional temozolomide treatment after radiation.
  • Be in good overall health with a performance status score of 0, 1, or 2.
  • Have adequate blood counts and organ function based on recent tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Must be willing to follow study procedures, including providing tissue samples and taking light-protective measures during the study.
  • Must provide written informed consent and agree to return for follow-up visits.

Exclusion Criteria

  • Have worsening disease after initial treatment, unless it's controlled with low-dose medication.
  • Be pregnant, breastfeeding, or unwilling to use contraception if of childbearing potential.
  • Have had recent surgery, radiation, or certain medications for glioblastoma.
  • Have not recovered from side effects of previous treatments.
  • Have other serious health conditions that could interfere with the study.
  • Have active infections or other uncontrolled illnesses.
  • Be taking other investigational drugs or have another active cancer within the last 3 years, except for certain skin or cervical cancers.
  • Have had a recent heart attack or severe heart failure.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic in Arizona85259ScottsdaleArizona
Mayo Clinic in Florida32224-9980JacksonvilleFlorida
Mayo Clinic in Rochester55905RochesterMinnesota

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