Actively Recruiting
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
Led by Debiopharm International SA · Updated on 2026-05-28
116
Participants Needed
17
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, and effectiveness of Debio 0123 combined with temozolomide (TMZ) and radiotherapy (RT) in adults with glioblastoma (GBM) or grade III astrocytoma. The study is divided into Phase 1, which focuses on finding safe dose levels and characterizing side effects, and Phase 2, which will assess how well Debio 0123 works at a recommended dose compared to standard treatment. This includes evaluating participants with recurrent or newly diagnosed GBM. Participants receive Debio 0123 capsules taken intermittently with TMZ capsules in 28-day cycles, for up to 2 years in some groups. Some groups also receive radiotherapy alongside these drugs for about 6 weeks. Phase 1 includes dose escalation and dose expansion stages to determine the best dose for Phase 2. One study group involving radiotherapy was permanently stopped due to safety concerns. During the study, participants undergo regular visits for treatment, monitoring, and safety checks. Assessments include physical exams, brain MRI scans using contrast, blood tests, heart function tests (ECG and echocardiogram), and evaluations of performance status using the Karnofsky Performance Scale. Researchers measure side effects, tumor response, drug levels in the blood, survival, and disease progression over up to about 66 months. Safety follow-up continues for 30 days after treatment ends.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures.
- Adults aged 18 years or older.
- Willing to provide a tumor sample if available.
- Adequate bone marrow, liver, and kidney function.
- Ability to follow scheduled visits, treatments, and tests.
- Willing to use effective contraception.
- Life expectancy of at least 3 months.
- Measurable or non-measurable brain tumor by MRI with contrast.
- Stable or decreasing steroid dose if using corticosteroids.
- Controlled seizures on stable medication.
- Up to 1 or 2 prior treatment lines depending on study phase and arm.
- Documented tumor recurrence or progression.
- Karnofsky Performance Status of 60 or higher.
- Specific diagnosis requirements for each study arm (GBM IDH-wildtype Grade 4 or Astrocytoma IDH-mutant Grade 3).
You will not qualify if you...
- Known allergy to Debio 0123, temozolomide, dacarbazine, or related ingredients.
- Previous treatment with any WEE1 inhibitor.
- Other active cancers needing treatment within past 2 years, except certain low-risk cancers.
- Left ventricular ejection fraction below 55%.
- Recent anticancer treatment or radiotherapy within 28 days before study start.
- Contraindication for MRI with contrast.
- Prior treatments overlapping with radiation fields for some arms.
- More than allowed prior therapy lines depending on study phase and arm.
- Prior radiation, chemotherapy, or specific local therapies for GBM for some arms.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years for Debio 0123 and temozolomide; up to 6 weeks for radiotherapy when given.
Participants receive intermittent Debio 0123 in combination with temozolomide, with or without radiotherapy depending on study arm.
Repeated 28-day cycles for up to 2 years for drug treatment; radiotherapy administered over up to 6 weeks when applicable
Duration - Up to approximately 26 months after treatment ends
Participants are monitored for safety and disease status after treatment ends, including assessment of adverse events and survival.
Visits up to 30 days after end of treatment and ongoing assessments up to 26 months
Trial Site Locations
Total: 17 locations
1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
2
New York University Langone Medical Center
New York, New York, United States, 10016
Actively Recruiting
3
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
4
Baylor Scott & White Research Institute
Dallas, Texas, United States, 75246
Actively Recruiting
5
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
6
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States, 78229
Actively Recruiting
7
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
8
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Actively Recruiting
9
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
10
Hospital Universitario Donostia
Donostia / San Sebastian, Spain, 20014
Actively Recruiting
11
Clinica Universidad de Navarra (CUN)
Madrid, Spain, 28027
Actively Recruiting
12
South Texas Accelerated Research Therapeutics (START)
Madrid, Spain, 28040
Actively Recruiting
13
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
14
Clinica Universidad de Navarra (CUN)
Pamplona, Spain, 31008
Actively Recruiting
15
Hospital Universitario Donostia
San Sebastián, Spain, 20014
Not Yet Recruiting
16
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
17
Universitaetsspital Zuerich
Zurich, Switzerland, CH-8091
Actively Recruiting
Research Team
D
Debiopharm International S.A
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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