A Phase 1 Study of Debio 0123 With Temozolomide for People With Glioblastoma

Share

Full Title

A Phase 1/2 Open-Label Study of Debio 0123 in Combination with Temozolomide in Adult Participants with Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination with Temozolomide and Radiotherapy in Adult Participants with Newly Diagnosed Glioblastoma

Purpose

Researchers want to find the best dose of Debio 0123 that can be given with temozolomide to treat glioblastoma. Glioblastoma is a type of brain cancer. The people in this study have glioblastoma that keeps growing even after treatment.

Debio 0123 blocks certain proteins that play a role in cancer growth. By blocking these proteins, Debio 0123 may slow or stop cancer growth. Debio 0123 might change your cells in a way that makes them respond better to temozolomide. If you join this study, you will take both Debio 0123 and temozolomide orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have glioblastoma that keeps growing even after treatment with temozolomide and radiation therapy.
  • Have completed previous treatment at least 4 weeks before taking the study drugs.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Lauren Schaff’s office at 212-610-0485.

Protocol

23-168

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05765812