RecruitingPhase 2NCT07326566

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

A Phase 2 Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Silevertinib, an Oral EGFR Inhibitor, in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma With Unmethylated MGMT Promoter and EGFRvIII


Sponsor

Black Diamond Therapeutics, Inc.

Enrollment

162 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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) help participants with GBM live longer without disease progression compared to treatment with temozolomide alone?


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called silevertinib combined with the standard chemotherapy drug temozolomide in patients with newly diagnosed glioblastoma (a serious brain cancer). The drug targets a protein called EGFR that is overactive in some brain tumors, and researchers hope that adding it to standard treatment will improve outcomes. **You may be eligible if...** - You have been newly diagnosed with glioblastoma (a specific aggressive type of brain tumor) - Your tumor shows certain genetic features, including EGFR alterations (and for the main part of the trial, specifically EGFRvIII and unmethylated MGMT) - You have completed surgery and standard radiation plus chemotherapy and your cancer has not yet progressed - It has been at least 4 weeks since your radiation therapy ended **You may NOT be eligible if...** - Your tumor has spread to multiple sites, outside the brain, or to the lining of the brain - Your tumor has progressed since starting treatment - You only had a biopsy (without tumor removal surgery) - You have received prior treatment targeting EGFR or with bevacizumab, immunotherapy, or certain implanted treatments - You plan to use Optune (a device-based therapy for brain cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGsilevertinib in combination with temozolomide

Participants enrolled into Part 1 (Safety Lead-In) or randomized to Arm A in Part 2 will receive silevertinib at dose determined in Part 1 until disease progression in combination with temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles.

DRUGtemozolomide (TMZ)

Participants randomized to Arm B will receive temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles


Locations(4)

Highlands Oncology Group

Springdale, Arkansas, United States

Atlantic Health

Summit, New Jersey, United States

Columbia University Irving Medical Center

New York, New York, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT07326566


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