Actively Recruiting
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
Led by Debiopharm International SA · Updated on 2026-04-28
116
Participants Needed
17
Research Sites
276 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 written informed consent before any study procedures
- Age 18 years or older
- Willing to provide archived or fresh tumor sample if available
- Adequate bone marrow, liver, and kidney function
- Willing and able to follow study visits, treatments, lab tests, and procedures
- Willing to use highly effective contraception
- Life expectancy of at least 3 months
- Measurable or non-measurable disease by brain MRI using RANO criteria
- Stable or decreasing corticosteroid dose (≤4 mg dexamethasone or ≤25 mg prednisone) for 7 days before treatment
- Controlled seizures on stable anti-epileptic drugs
- No more than 1 prior treatment line for Phase 1 Dose Expansion and Phase 2; up to 2 for Phase 1 Arm A, with first-line TMZ-based chemoradiotherapy
- Documented disease recurrence or progression by biopsy or MRI
- Karnofsky Performance Status (KPS) ≥60
- For Phase 1 Arm A: histologically confirmed GBM IDH-wildtype Grade 4 or astrocytoma IDH-mutant Grade 3
- For Phase 1 Arms B and C: new diagnosis of GBM IDH-wildtype Grade 4 with prior surgery only, KPS ≥70
- For Phase 1 Dose Expansion and Phase 2: histologically confirmed GBM IDH-wildtype Grade 4
You will not qualify if you...
- More than 2 prior treatment lines for GBM or astrocytoma in Phase 1 Arm A
- Contraindication to gadolinium-based contrast-enhanced MRI
- Treatment with anticancer drugs, biologics, investigational treatment, or curative radiotherapy within 28 days before study treatment
- Allergy to Debio 0123, temozolomide, dacarbazine, or any excipients
- Prior exposure to any WEE1 inhibitor
- Other active malignancies requiring treatment within 2 years except certain low-risk or treated cancers
- Left ventricular ejection fraction below 55%
- For Phase 1 Arms B and C: prior radiation, chemotherapy, biological therapy, brachytherapy, implanted chemotherapy, or local therapies for GBM
- For Phase 1 Arms B and C: prior therapy causing radiation field overlap
- More than 1 prior systemic therapy line for GBM in Phase 1 Dose Expansion and Phase 2
AI-Screening
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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
CONTACT
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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