Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for glioblastoma? drug combo trial targets aggressive brain tumors

NCT ID NCT07326566

Disease control Sponsor: Black Diamond Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 18 times

Summary

This Phase 2 trial tests whether adding the experimental drug silevertinib to standard chemotherapy (temozolomide) helps people with a specific type of newly diagnosed glioblastoma live longer without their cancer worsening. The study includes 162 participants whose tumors have certain genetic markers (unmethylated MGMT and EGFRvIII). After surgery and radiation, some get the combo, others get chemotherapy alone, and researchers compare outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
silevertinib (an oral EGFR inhibitor) combined with temozolomide (chemotherapy)
What this could lead to
If it works, this could improve how long people with a hard-to-treat type of glioblastoma live without their cancer growing, compared to standard chemotherapy alone.
What could go wrong
This is a Phase 2 trial with only 162 participants, so results are still early. The combination may not work better than temozolomide alone, and side effects from the two drugs together could be more severe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 162 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Brain cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

brain cancer central nervous system disorder glioblastoma glioma glioma susceptibility 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain cancer Central nervous system diseases GBM Glioblastoma (GBM) Glioblastoma multiforme (GBM) GLIOMA Newly diagnosed glioblastoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    30 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlantic Health

    RECRUITING

    Summit, New Jersey, 07901, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Cleveland Clinic Taussig Cancer Center

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

    Contact Email: •••••@•••••

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Henry Ford Cancer- Detroit

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Highlands Oncology Group

    RECRUITING

    Springdale, Arkansas, 72762, United States

  • Huntsman Cancer Institute, University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Inova Schar Cancer Institute

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • John Theurer Cancer Center at Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Johns Hopkins Sibley Memorial Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20016, United States

  • Johns Hopkins Sidney Kimmel Cancer Center - Baltimore

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Miami Cancer Institute

    RECRUITING

    Miami, Florida, 33176, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • Northwell Health Center for Advanced Medicine - Brain Tumor Center

    RECRUITING

    Lake Success, New York, 11042, United States

    Contact Email: •••••@•••••

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Piedmont Oncology Research

    RECRUITING

    Atlanta, Georgia, 30318, United States

  • Prisma Health

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Rutgers Cancer Institute

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

    Contact Email: •••••@•••••

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Alabama at Birmingham O'Neal Comprehensive Cancer Center

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68106, United States

  • VCU Massey Comprehensive Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Washington University School of Medicine Siteman Cancer Center

    RECRUITING

    St Louis, Missouri, 63108, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.