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Studie av Silevertinib med Temozolomide for behandling av nyoppdaget GBM med umetylert MGMT og EGFRvIII

30. oktober 2026 oppdatert av: Black Diamond Therapeutics, Inc.

En fase 2 randomisert, multicenter-studie for å evaluere effektiviteten og sikkerheten til Silevertinib, en oral EGFR-hemmer, i kombinasjon med Temozolomide hos pasienter med nydiagnostisert glioblastom med umetylert MGMT-promotor og 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) help participants with GBM live longer without disease progression compared to treatment with temozolomide alone?

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Silevertinib was designed to block a growth signal important to some cancers where tumors grow because of changes in a protein called epidermal growth factor receptor (EGFR). These changes are called gene amplifications, mutations, or alterations and are found in tumors. Temozolomide is a drug that fights cancer cells by damaging DNA (the genetic material of cells), which could cause the tumor cells to die. It is the standard treatment for adults with certain types of newly diagnosed brain cancer, like GBM. It is given together with radiotherapy and sometimes afterward as maintenance therapy.

This study has 2 parts. To be eligible for the study, participants must have received a diagnosis of GBM, had surgery to remove or reduce the size of the tumor, and received adjuvant radiation therapy and temozolomide. No other prior treatments for GBM are allowed.

In Part 1 (called the Safety Lead-in), participants will receive silevertinib combined with temozolomide to determine if the combination is safe and to find the best dose. Approximately 12 participants are expected to enroll in Part 1 of the study.

In Part 2, all participants will be randomized to one of two different treatment groups:

  • Group 1: Silevertinib + temozolomide
  • Group 2: Temozolomide only

Approximately 150 participants are expected to be randomized in Part 2 of the study.

In both Part 1 and Part 2, the study treatment will be given in "cycles". Each cycle will be 28 days. After a cycle ends, the next cycle will immediately begin the next day. Both silevertinib and temozolomide will be taken orally. Silevertinib is taken daily until disease progression and temozolomide is taken for the first 5 days of each cycle (up to 6 cycles).

If participants are found to be eligible for the study and enrolled (in Part 1) or randomized (in Part 2), participants will:

  • Take the study drug as directed
  • Return for frequent clinic visits to monitor overall health and status of GBM
  • Undergo imaging and other laboratory tests to determine status of GBM
  • Complete a paper diary at home to record the date and time(s) that the study drug is taken

Studietype

Intervensjonell

Registrering (Antatt)

162

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35233
        • Rekruttering
        • University of Alabama at Birmingham O'Neal Comprehensive Cancer Center
        • Ta kontakt med:
    • Arkansas
      • Springdale, Arkansas, Forente stater, 72762
        • Rekruttering
        • Highlands Oncology Group
        • Ta kontakt med:
    • California
      • La Jolla, California, Forente stater, 92037-0845
        • Rekruttering
        • UCSD Moores Cancer Center
        • Ta kontakt med:
      • Los Angeles, California, Forente stater, 90048
        • Rekruttering
        • Cedars-Sinai Medical Center
        • Ta kontakt med:
      • Orange, California, Forente stater, 92868
        • Rekruttering
        • UC Irvine Health
        • Ta kontakt med:
      • Palo Alto, California, Forente stater, 94304
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06510
        • Rekruttering
        • Yale Cancer Center
        • Ta kontakt med:
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20016
        • Rekruttering
        • Johns Hopkins Sibley Memorial Hospital
        • Ta kontakt med:
    • Florida
      • Miami, Florida, Forente stater, 33176
      • Tampa, Florida, Forente stater, 33612
        • Rekruttering
        • Moffitt Cancer Center
        • Ta kontakt med:
    • Georgia
      • Atlanta, Georgia, Forente stater, 30318
        • Rekruttering
        • Piedmont Oncology Research
        • Ta kontakt med:
    • Maine
      • Scarborough, Maine, Forente stater, 04074
        • Rekruttering
        • Maine Health Cancer Care and Blood Disorders - Scarborough
        • Ta kontakt med:
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • Rekruttering
        • Johns Hopkins Sidney Kimmel Cancer Center - Baltimore
        • Ta kontakt med:
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Rekruttering
        • Massachusetts General Hospital
        • Ta kontakt med:
      • Boston, Massachusetts, Forente stater, 02215
        • Rekruttering
        • Beth Israel Deaconess Medical Center
        • Ta kontakt med:
      • Boston, Massachusetts, Forente stater, 02215
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
      • Detroit, Michigan, Forente stater, 48202
        • Rekruttering
        • Henry Ford Cancer- Detroit
        • Ta kontakt med:
        • Ta kontakt med:
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
    • Missouri
      • St Louis, Missouri, Forente stater, 63108
        • Rekruttering
        • Washington University School of Medicine Siteman Cancer Center
        • Ta kontakt med:
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68106
        • Rekruttering
        • University of Nebraska Medical Center
        • Ta kontakt med:
    • New Jersey
      • Hackensack, New Jersey, Forente stater, 07601
        • Rekruttering
        • John Theurer Cancer Center at Hackensack University Medical Center
        • Ta kontakt med:
      • New Brunswick, New Jersey, Forente stater, 08901
        • Rekruttering
        • Rutgers Cancer Institute
        • Ta kontakt med:
      • Summit, New Jersey, Forente stater, 07901
    • New York
      • Lake Success, New York, Forente stater, 11042
        • Rekruttering
        • Northwell Health Center for Advanced Medicine - Brain Tumor Center
        • Ta kontakt med:
      • New York, New York, Forente stater, 10032
      • The Bronx, New York, Forente stater, 10461
        • Rekruttering
        • Montefiore Medical Center
        • Ta kontakt med:
    • North Carolina
      • Winston-Salem, North Carolina, Forente stater, 27157
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
        • Rekruttering
        • Cleveland Clinic Taussig Cancer Center
        • Ta kontakt med:
      • Columbus, Ohio, Forente stater, 43210
        • Rekruttering
        • Ohio State University
        • Ta kontakt med:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Rekruttering
        • Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center
        • Ta kontakt med:
      • Pittsburgh, Pennsylvania, Forente stater, 15232
        • Rekruttering
        • UPMC Hillman Cancer Center
        • Ta kontakt med:
    • South Carolina
      • Greenville, South Carolina, Forente stater, 29605
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • UT MD Anderson Cancer Center
        • Ta kontakt med:
    • Utah
      • Salt Lake City, Utah, Forente stater, 84112
        • Rekruttering
        • Huntsman Cancer Institute, University of Utah
        • Ta kontakt med:
    • Virginia
      • Fairfax, Virginia, Forente stater, 22031
        • Rekruttering
        • Inova Schar Cancer Institute
        • Ta kontakt med:
      • Richmond, Virginia, Forente stater, 23298
        • Rekruttering
        • VCU Massey Comprehensive Cancer Center
        • Ta kontakt med:
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792
        • Rekruttering
        • University of Wisconsin Carbone Cancer Center
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: silevertinib and temozolomide

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
Legemiddel: silevertinib 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.

Andre navn:
  • Temodar
  • TMZ
  • BDTX-1535
Aktiv komparator: temozolomide

temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles
Legemiddel: temozolomide (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

Andre navn:
  • Temodar
  • TMZ

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)
Tidsramme: 12 months

Progression-free survival, defined as the time from the date of randomization to the date of first disease progression per RANO 2.0 by BICR assessment or death from any cause, whichever occurs first.
12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival
Tidsramme: 18 months

Overall survival defined as time from first dose of study drug to death from any cause.
18 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Black Diamond Therapeutics, Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. mai 2026

Primær fullføring (Antatt)

1. november 2028

Studiet fullført (Antatt)

1. mars 2029

Datoer for studieregistrering

Først innsendt

7. januar 2026

Først innsendt som oppfylte QC-kriteriene

7. januar 2026

Først lagt ut (Faktiske)

8. januar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. oktober 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BDTX-1535-201

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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