Debio 0123 with Temozolomide and Radiotherapy for Glioblastoma
This study is testing Debio 0123 in combination with temozolomide (a chemotherapy drug) for adults with recurrent or progressive glioblastoma (a type of brain cancer). It's also looking at Debio 0123 with temozolomide and radiotherapy (radiation treatment) for adults with newly diagnosed glioblastoma. The main goal for this phase of the study is to find the safest dose of Debio 0123 when given with these other treatments and to understand any side effects. You may be able to join if you are 18 or older and have adequate organ function. The study aims to enroll 116 participants.
- Study design
- This is an interventional study, meaning participants receive specific treatments. It is currently in Phase 1, focusing on finding the right dose and understanding safety.
- What's involved
- You would need to provide a tumor sample if available. The study will monitor for side effects through lab tests, vital signs, ECG (heart tracing), and ECHO (ultrasound of the heart).
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety for up to 30 days after treatment ends, which could be up to approximately 26 months for some groups and 3.5 months for others.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05765812
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
Recruiting
PHASE1Ages 18+InterventionalTreatmentDebiopharm International SA
~116 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Debio 0123TemozolomideRadiotherapy
At a glance
Recruiting sites
16 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1 (Dose Escalation): Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Measured over Phase 1: Arm A: Cycle 1 (Cycle=28 days); Arms B and C: Up to approximately 1.8 months
+8 more outcomes measured
Conditions
Where it's being run
16 sites across 7 statesSpain7
Texas3
New York2
Illinois1
Utah1
Washington1
Switzerland1
Study leadership
- Study Director · STUDY_DIRECTOR · Debiopharm International SA
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Signed written informed consent approved before undertaking any study-specific procedures.
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.
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.
Exclusion
Known contraindication to undergoing for Gd-based, contrast-enhanced MRI.
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.
What this trial measures
- Phase 1 (Dose Escalation): Number of Participants Experiencing Dose-limiting Toxicities (DLTs)Phase 1: Arm A: Cycle 1 (Cycle=28 days); Arms B and C: Up to approximately 1.8 months
- Phase 1 (Dose Escalation): Number of Participants With At Least One Treatment-emergent Adverse Event (TEAE)Up to 30 days after the end of treatment (Arm A: Up to approximately 26 months and Arms B and C: Up to approximately 3.5 months)
- Phase 1 (Dose Escalation): Number of Participants With Clinically Significant Abnormalities in Laboratory, Vital Signs, Electrocardiogram (ECG), and Echocardiogram (ECHO) ParametersUp to 30 days after the end of treatment (Arm A: Up to approximately 26 months and Arms B and C: Up to approximately 3.5 months)
- Phase 1 (Dose Escalation): Change From Baseline in Karnofsky Performance Status (KPS) ScoreUntil disease progression or end of study (approximately 66 months)
KPS is an assessment tool for functional impairment. It is a standard way of measuring the ability of participants with cancer to perform ordinary tasks. The KPS scores range from 0 (death) to 100 (no evidence of disease). A higher score means the participant is better able to carry out daily activities.
- Phase 1 (Dose Expansion): Number of Participants With At Least One Treatment-emergent Adverse Event (TEAE)Up to approximately 26 months
- Phase 1 (Dose Expansion): Change from Baseline in Tumor Size Assessed by Objective Response (OR) as per Response Assessment in Neuro-oncology (RANO) CriteriaFrom the start of study treatment until disease progression or end of study (up to approximately 66 months)
- Phase 1 (Dose Expansion): Plasma Concentration of Debio 0123 and its MetabolitePredose and at multiple timepoints up to 6 hours post dose up to Day 15 of Cycle 1 (Cycle=28 days)
- Phase 1 (Dose Expansion): Pharmacodynamic(s) PDy, Change from baseline in Phosphorylated Cell Division Cycle (pCDC2)Predose and 4 to 6 hours post dose on Day 10 of Cycle 1 (Cycle=28 days)
- Phase 2: Overall Survival (OS)From the start of study treatment until death from any cause or end of study (up to approximately 66 months)