Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 2interventionalRules rewrite

Phase 2: testing silevertinib in combination with temozolomide for Glioblastoma (GBM)

This study wants 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?

Official registry: https://clinicaltrials.gov/study/NCT07326566 · Black Diamond Therapeutics, Inc. · enrollment listed as 162

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are silevertinib in combination with temozolomide, or temozolomide (TMZ). The registry lists allocation as randomized. This study wants 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.

They plan to enroll about 162 people at 38 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: silevertinib in combination with temozolomide, temozolomide (TMZ)

Primary outcome (registry wording): Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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 certification)
  • For Part 1 (Safety Lead-in) ONLY: EGFR alterations
  • For Part 2 (randomly assigned, Controlled Trial) ONLY: EGFRvIII
  • For Part 2 (randomly assigned, Controlled Trial) ONLY: Unmethylated MGMT promoter tumor status based on a validated assay
  • No treatment for newly diagnosed GBM other than surgery followed by standard-of-care adjuvant postoperative radiation (54 to 60 Gy) and TMZ chemotherapy
  • At least 4 weeks since completion of radiation therapy, with a post-radiation MRI showing no progression

Public study contact (from the registry)

Black Diamond Therapeutics Clinical Trial Navigation Service

(866) 955-4397

blackdiamondtx@careboxhealth.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

38 listed

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FAQ about this NCT record

Is NCT07326566 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07326566?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07326566?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary