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 (NCT05765812)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Northwestern Memorial Hospital — Chicago, Illinois
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (16 Sites)
- Northwestern Memorial Hospital — Chicago, Illinois
- New York University Langone Medical Center — New York, New York
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York
- Baylor Scott & White Research Institute — Dallas, Texas
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas
- Huntsman Cancer Institute — Salt Lake City, Utah
- Fred Hutchinson Cancer Research Center — Seattle, Washington
- Hospital Universitario Vall d'Hebron — Barcelona,
- Hospital Universitario Donostia — Donostia / San Sebastian,
- Clinica Universidad de Navarra (CUN) — Madrid,
- South Texas Accelerated Research Therapeutics (START) — Madrid,
- Hospital Universitario 12 de Octubre — Madrid,
- Clinica Universidad de Navarra (CUN) — Pamplona,
- Hospital Clinico Universitario de Valencia — Valencia,
- Universitaetsspital Zuerich — Zurich,
📞 Contact the Study Coordinator
Phone: +41 21 321 01 11
Email: clinicaltrials@debiopharm.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.