A 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
Sponsor: Debiopharm International SA • ClinicalTrials.gov ID: NCT05765812
Recruiting for Similar Conditions?
Sponsors are looking for patients like you. See if you qualify for compensated research studies.
Check Eligibility →Description
The primary purpose of the Phase 1 (Dose Escalation) of this study is to identify the dose-limiting toxicities (DLTs) of Debio 0123 combined with temozolomide (TMZ) (Arm A) and with TMZ and radiotherapy (RT) (Arms B and C) and to characterize the safety and tolerability of these combinations in adult participants with glioblastoma (GBM). Arm B which was previously added to the protocol, has been permanently halted per the safety monitoring committees' decision on the safety findings of this arm. The primary purpose of Phase 1 (Dose expansion) of the study is to assess the doses studied under Phase 1 (Dose Escalation) Arm A and identify the recommended dose (RD) for further development. The Phase 2 will start once the RD Phase 1 has been defined. The primary objective of Phase 2 is to assess the efficacy of Debio 0123 at the RD for further development in combination with TMZ, compared to the standard of care (SOC) in adult participants with GBM.
Interventions
-
Debio 0123
(Drug)
Administered as capsules.
-
Temozolomide
(Drug)
Administered as capsules.
-
Radiotherapy
(Radiation)
Administered in accordance with the local clinical practice and applicable Radiation Therapy Oncology Group (RTOG) or the European Organization for Research and Treatment of Cancer (EORTC) guidelines.
Eligibility criteria
Conditions
Locations
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- New York University Langone Medical Center — New York, New York, United States
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Baylor Scott & White Research Institute — Dallas, Texas, United States
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas, United States
- Huntsman Cancer Institute — Salt Lake City, Utah, United States
- Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
- Hospital Universitario Vall d'Hebron — Barcelona, Spain
- Hospital Universitario Donostia — Donostia / San Sebastian, Spain
- Clinica Universidad de Navarra (CUN) — Madrid, Spain
- South Texas Accelerated Research Therapeutics (START) — Madrid, Spain
- Hospital Universitario 12 de Octubre — Madrid, Spain
- Clinica Universidad de Navarra (CUN) — Pamplona, Spain
- Hospital Clinico Universitario de Valencia — Valencia, Spain
- Universitaetsspital Zuerich — Zurich, Switzerland
Partner with Nurenyx
Showcase your study to thousands of motivated patients matching your criteria.
Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
View Official Record