NCT05765812 · Debiopharm International SA
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
What this study is about
The primary purpose of the Phase 1 (gradually increasing doses) of this study is to identify the dose-limiting toxicities (DLTs) of Debio 0123 combined with temozolomide (TMZ) (treatment group$1 A) and with TMZ and radiotherapy (RT) (treatment group$1 B and C) and to characterize the safety and how well patients handle the treatment of these combinations in adult participants with glioblastoma (GBM). treatment group$1 B which was previously added to the protocol, has been permanently halted per the safety monitoring committees' decision on the safety findings of this treatment group$1.
View original scientific description
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.
Interventions
DRUG
Debio 0123
Administered as capsules.
DRUG
Temozolomide
Administered as capsules.
RADIATION
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.
Primary outcome measures
Phase 1 (Dose Escalation): Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Time frame: 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)
Time frame: 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) Parameters
Time frame: 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): Change From Baseline in Karnofsky Performance Status (KPS) Score
Time frame: Until 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)
Time frame: 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) Criteria
Time frame: From 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 Metabolite
Time frame: Predose 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)
Time frame: Predose and 4 to 6 hours post dose on Day 10 of Cycle 1 (Cycle=28 days)
Phase 2: Overall Survival (OS)
Time frame: From the start of study treatment until death from any cause or end of study (up to approximately 66 months)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- for Phase 1 and Phase 2:
- 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
Where
- Chicago, Illinois
- New York, New York
- Dallas, Texas
- Houston, Texas
- San Antonio, Texas
- Salt Lake City, Utah
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 12, 2026 · Source of record for eligibility and locations