NCT07326566 Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
| NCT ID | NCT07326566 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Black Diamond Therapeutics, Inc. |
| Condition | Glioblastoma (GBM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 162 participants |
| Start Date | 2026-05-05 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 162 participants in total. It began in 2026-05-05 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Key Inclusion 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 certification). * For Part 1 (Safety Lead-in) ONLY: EGFR alterations. * For Part 2 (Randomized, Controlled Trial) ONLY: EGFRvIII. * For Part 2 (Randomized, 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. Key Exclusion Criteria: * Recurrent multifocal disease, metastatic, leptomeningeal, or extracranial GBM, or gliomatosis cerebri. * Progression of GBM prior to Enrollment, Screening, or Randomization. * Biopsy-only/no resectional surgery. * Prior or concomitant treatment for GBM with an EGFR-targeting agent, including silevertinib, bevacizumab, cytotoxic chemotherapy, immunotherapy, experimental therapies, Gliadel wafers, GammaTile®, or other intratumoral or intracavitary antineoplastic therapy. * Intent to use Optune® (TTF). * Significant other uncontrolled health conditions or other malignancies.
Contact & Investigator
Black Diamond Therapeutics Clinical Trial Navigation Service
✉ blackdiamondtx@careboxhealth.com📞 (866) 955-4397
Frequently Asked Questions
Who can join the NCT07326566 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma (GBM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07326566 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07326566 currently recruiting?
Yes, NCT07326566 is actively recruiting participants. Contact the research team at blackdiamondtx@careboxhealth.com for enrollment information.
Where is the NCT07326566 trial being conducted?
This trial is being conducted at Springdale, United States, Los Angeles, United States, New Haven, United States, Washington D.C., United States and 11 additional locations.
Who is sponsoring the NCT07326566 clinical trial?
NCT07326566 is sponsored by Black Diamond Therapeutics, Inc.. The trial plans to enroll 162 participants.
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