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
NCT ID: NCT05765812
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
116 participants
INTERVENTIONAL
2023-05-15
2028-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1 (Dose Escalation): Arm A - Debio 0123 + Temozolomide
Participants will receive intermittent Debio 0123, escalating doses along with temozolomide (TMZ) in each 28-day cycle for up to 2 years.
Debio 0123
Administered as capsules.
Temozolomide
Administered as capsules.
Phase 1 (Dose Escalation): Arm B - Debio 0123 + Temozolomide + Radiotherapy
Participants will receive intermittent Debio 0123, escalating doses along with TMZ and concomitant administration of radiotherapy (RT) for up to 6 weeks. As per Protocol \_V4.0 Arm B has been permanently halted.
Debio 0123
Administered as capsules.
Temozolomide
Administered as capsules.
Radiotherapy
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.
Phase 1 (Dose Escalation): Arm C - Debio 0123 + Temozolomide + Radiotherapy
Participants will receive intermittent Debio 0123, escalating doses along with TMZ and concomitant administration of radiotherapy (RT) for up to 6 weeks.
Debio 0123
Administered as capsules.
Temozolomide
Administered as capsules.
Radiotherapy
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.
Phase 1 (Dose Expansion): Debio 0123 + Temozolomide
Participants will receive Debio 0123, escalating doses along with temozolomide (TMZ) in each 28-day cycle for up to 2 years. Participants will receive one of the 2 selected doses for further investigation.
Debio 0123
Administered as capsules.
Temozolomide
Administered as capsules.
Phase 2: Debio 0123 RD + Temozolomide
Participants will receive intermittent Debio 0123 RD along with TMZ in each 28-day cycle for up to 2 years.
Debio 0123
Administered as capsules.
Temozolomide
Administered as capsules.
Interventions
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Debio 0123
Administered as capsules.
Temozolomide
Administered as capsules.
Radiotherapy
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
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Inclusion Criteria
* Age ≥18 years of age.
* Willing to provide archived or fresh tumor sample, if available. Receipt of tumor sample is not required for the start of study treatment.
* Adequate bone marrow, hepatic, and renal function.
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
* Willing to practice highly effective methods of contraception.
* Life expectancy of at least 3 months in the best judgment of the Investigator.
* Measurable or non-measurable disease as per RANO criteria by gadolinium (Gd)-based contrast-enhanced brain magnetic resonance imaging (MRI).
* Participants receiving corticosteroids must be on a stable or decreasing dose of ≤4 mg daily dexamethasone (or ≤25 mg prednisone) for the 7 days prior to the start of study treatment.
* Participants with seizures must be adequately controlled on a stable regimen of anti-epileptic drugs.
• A maximum of 1 \[for Phase 1 (Dose Expansion) and phase 2\] or 2 (Phase 1 Arm A) prior treatment lines of which first-line must be treatment with TMZ-based chemoradiotherapy (TMZ concomitantly with RT).
Note: Only 1 prior line of systemic therapy is allowed; combination therapy with TMZ and RT with or without subsequent TMZ maintenance treatment is considered as 1 systemic line. Prior surgery, radiation, or localized delivery of therapeutic agents (i.e., carmustine-containing wafers \[GLIADEL®\]) for first recurrence is allowed.
* Documented disease recurrence or progression by diagnostic biopsy or Gd-based contrast-enhanced brain MRI as per RANO criteria.
* KPS ≥60.
* Participants must have one of the following histopathologically proven diagnoses (WHO 2021):
* GBM Isocitrate dehydrogenase (IDH)-wildtype Grade 4 which may include secondary GBMs (i.e., those that progress from low-grade gliomas).
* Astrocytoma, IDH-mutant, Grade 3
* Participants must have a new, histopathologically proven diagnosis of GBM, IDH-wildtype, Grade 4 (based on WHO 2021), which may include secondary GBMs (i.e., those that progress from low-grade gliomas) if the prior treatment included surgery only.
* KPS ≥70.
• Participants must have a histopathologically proven diagnosis of GBM, IDH-wildtype Grade 4 WHO 2021
Exclusion Criteria
* Any anticancer treatment, monoclonal antibodies/biologics, investigational treatment, or RT with curative intent within 28 days prior to starting study treatment.
* Hypersensitivity to Debio 0123, TMZ, dacarbazine, or any of the excipients found in the formulation for Debio 0123 or TMZ.
* Prior exposure to any WEE1 inhibitor.
* History of other malignancies requiring active treatment in the last 2 years prior to the first dose of study treatment except for superficial bladder cancers, adequately treated low-risk prostate cancer under active surveillance, ductal carcinoma in situ or other carcinomas in situ, and non-melanoma skin cancers (basal cell/squamous cell skin cancer) that have been treated with curative intent.
* Left ventricular ejection fraction (LVEF) below 55%.
* Prior radiation, chemotherapy, biological therapy, interstitial brachytherapy, implanted chemotherapy, therapeutics delivered by local injection or convection-enhanced delivery for GBM.
* Prior therapy that would result in an overlap of the radiation fields.
• Prior treatment with more than 1 line of systemic therapy for GBM, IDH-wildtype, Grade 4 (based on WHO 2021). Combination therapy with TMZ and RT with or without subsequent TMZ maintenance treatment is considered as 1 systemic line.
18 Years
ALL
No
Sponsors
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Debiopharm International SA
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Debiopharm International SA
Locations
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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 Universitario Donostia
San Sebastián, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Universitaetsspital Zuerich
Zurich, , Switzerland
Countries
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Central Contacts
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Other Identifiers
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2022-502156-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1283-6423
Identifier Type: OTHER
Identifier Source: secondary_id
Debio 0123-GBM-105
Identifier Type: -
Identifier Source: org_study_id