Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII

The purpose of this study is to see if combining silevertinib with temozolomide after surgery and radiotherapy helps treat newly diagnosed glioblastoma (GBM) better than using temozolomide alone in the maintenance setting. Specifically, this study is being done to find answers to the following questions: * How much of the study drugs (silevertinib combined with temozolomide) should be given to participants with GBM? * What are the side effects participants have when taking the study drug (silevertinib combined with temozolomide)? * Can the study drug (silevertinib combined with temozolomide)

Trial Details

NCT ID
NCT07326566
Phase
PHASE2
Sponsor
Black Diamond Therapeutics, Inc.
Status
RECRUITING
Cancer Type
Glioblastoma (GBM) Brain Cancer
Interventions
  • silevertinib in combination with temozolomide
  • temozolomide (TMZ)
Locations (sample)
  • Springdale, Arkansas, United States|36.18674,-94.12881
  • Los Angeles, California, United States|34.05223,-118.24368
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Miami, Florida, United States|25.77427,-80.19366
  • Tampa, Florida, United States|27.94752,-82.45843

Key Eligibility Criteria

  • Newly diagnosed histologically confirmed glioblastoma that is isocitrate dehydrogenase wild type (IDH-WT).
  • Positive EGFR status in the brain tumor as determined by a commercially available test or validated laboratory assay (CLIA or comparable certificat…
  • For Part 1 (Safety Lead-in) ONLY: EGFR alterations.
  • For Part 2 (Randomized, Controlled Trial) ONLY: EGFRvIII.

For full eligibility, visit ClinicalTrials.gov.

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