RecruitingEarly Phase IEN originalGlioma (brain cancer)

BGB-58067 in Newly Diagnosed Glioblastoma Patients With MTAP-Deleted Tumors

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

This is an open-label, multi-center, Phase 0/2 trial designed to enroll up to 78 total participants with suspected newly diagnosed glioblastoma (nGBM) who are scheduled for surgical resection to accrue at least 14 participants in Arm A and 10 participants in Arm B. The trial will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of BGB-58067. The study is composed of a Phase 0 and expansion Phase 2 component. The Phase 0 primary endpoint will be suppression of symmetric dimethylarginine (SDMA) in tumor tissue measured by immunohistochemistry (IHC). The Phase 2 primary endpoint will be 12-month overall survival rate (OS12). The Phase 0 secondary endpoint will be to characterize the PK of BGB-58067 in tumor tissue, plasma, and cerebrospinal fluid (CSF). The Phase 2 secondary endpoints will include assessing the safety profile of BGB-58067 and evaluating clinical efficacy of BGB 58067 using overall survival (OS) and the 6-month progression-free survival rate (PFS6) estimated by Kaplan-Meier (K-M) methods.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Nowo rozpoznany glejiak złośliwy mózgu, który nie był wcześniej leczony (poza biopsją)
  • Wiek co najmniej 18 lat
  • Widoczny guz przed operacją o wymiarach co najmniej 1 cm
  • Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu
  • Prawidłowe wyniki badań krwi (liczba białych krwinek, płytki, hemoglobina)
  • Prawidłowa funkcja wątroby i nerek
  • Dla kobiet: ujemny test ciąży przed rozpoczęciem leczenia

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
August 21, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

St. Joseph's Hospital and Medical Center

Phoenix, United States

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/22/2026.

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