BI 907828 (Brigimadlin) İlacının Tümördeki Alımının (Faz 0) ve Radyoterapi ile Birlikte En Yüksek Tolere Edilebilir Dozunun (Faz 1a) Glioblastom Adlı Beyin Tümörü Olan Kişilerde Belirlenmesine Yönelik Bir Çalışma

Sade dilde özet

Bu çalışma, glioblastom (glioblastoma) adı verilen bir beyin tümörü olan kişilerde BI 907828 (Brigimadlin) ilacının tümöre ne kadar ulaştığını ve radyoterapi ile birlikte güvenle verilebilecek en yüksek dozunu araştırmaktadır. Çalışmaya, ameliyatla tümör çıkarımı planlanan, 18 yaş ve üzeri hastalar katılabilmiştir. Çalışma Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 1 (Phase 1)

Durum

Tamamlandı

Sponsor

Boehringer Ingelheim

Müdahale

BI 907828 (Brigimadlin)

Başlangıç

30.11.2022

Tahmini bitiş

31.07.2025

Ülkeler

United States, Belgium, Spain

İlgili genler

Merkezler

• Phoenix, United States
• New Haven, United States
• Jacksonville, United States
• Rochester, United States
• Leuven, Belgium
• Barcelona, Spain
• Madrid, Spain

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion criteria

* Inclusion criteria Part Phase 0:

  * Histologically (if prior biopsy) or radiologically diagnosed glioblastoma.
  * Neurosurgical tumor resection is indicated and planned according to the assessment of the treating physician.
  * Patients must be at least 18 years old.
  * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (an ECOG of 2 is acceptable, if it is due to non-cancer-related disability, and after agreement with the sponsor).
* Inclusion criteria Part Phase Ia:

  * Histologically demonstrated diagnosis of TP53 wild type glioblastoma harboring unmethylated O6-methylguanine-DNA-methyltransferase (MGMT) promoters. Glioblastoma definition according to 2021 World Health Organization (WHO) Classification of Central Nervous System (CNS) tumors, i.e. IDH- wild type only.
  * Patient has undergone neurosurgical tumor resection and is eligible for standard radiotherapy.
  * Patients must be neurologically stable based on the judgement of the treating physician. The use of corticosteroids and anti-seizure medication is allowed and should be at a stable or decreasing dose for at least 7 days before inclusion in the trial. Anti-seizure medication should not include agents that interact with BI 907828 (Brigimadlin).
  * For patients, who have participated in Phase 0, the interval between the single dose of BI 907828 (Brigimadlin) and subsequent Phase 1a treatment must be at least 21 days.

Further inclusion criteria applies.

Exclusion criteria

* Exclusion criteria Part Phase 0:

  * Known TP53 mutant glioblastoma (Note: testing is not mandatory for inclusion).
  * Known Isocitrate dehydrogenase (IDH) mutant grade IV astrocytoma (Note: testing is not mandatory for inclusion).
  * Patient who must receive or intends to receive restricted medications.
  * Patients with pacemakers or other metallic implants that can interfere with the magnetic field during Magnetic Resonance Imaging (MRI) investigations.
  * Inability to undergo contrast-enhanced MRI (Glomerular Filtration Rate (GFR) \<30 mL/min).
* Exclusion criteria Part Phase Ia:

  * Patients who have received previous systemic therapy (with the exception of patients who participated in Phase 0) or radiotherapy for glioblastoma.
  * Patients who must or intend to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
  * Patients with pacemakers or other metallic implants that can interfere with the magnetic field during MRI investigations.
  * Inability to undergo contrast-enhanced MRI (GFR \<30 mL/min). Further exclusion criteria applies.