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Debio 0123 + Temozolomide for Glioblastoma
Phase 1 & 2
Recruiting
Research Sponsored by Debiopharm International SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until disease progression or end of study (approximately 66 months)
Awards & highlights
Summary
This trial is testing a new drug called Debio 0123 combined with standard treatments for adults with aggressive brain cancer. It aims to find the best dose, ensure safety, and check if it works better than current treatments.
Who is the study for?
Adults with recurrent or newly diagnosed glioblastoma who've had limited prior treatments can join this trial. They must have a performance status indicating they're mostly independent, stable minor symptoms like seizures, and their major organs should be functioning well. Participants need to commit to the study schedule and agree to use effective birth control.
What is being tested?
The trial is testing Debio 0123 in combination with Temozolomide (TMZ), both alone and alongside radiotherapy for glioblastoma patients. Phase 1 determines the safest dose while Phase 2 compares its effectiveness against standard care.
What are the potential side effects?
Potential side effects of Debio 0123 are not specified but may include typical reactions related to chemotherapy such as nausea, fatigue, blood cell count changes, and increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until disease progression or end of study (approximately 66 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until disease progression or end of study (approximately 66 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1 (Dose Escalation): Change From Baseline in Karnofsky Performance Status (KPS) Score
Secondary study objectives
Phase 1 (Dose Escalation): Plasma Concentration of Temozolomide
Phase 1 (Dose Expansion): Change From Baseline in KPS Score
Phase 2: Change From Baseline in KPS Score
+1 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Phase 2: Debio 0123 RD + TemozolomideExperimental Treatment2 Interventions
Participants will receive intermittent Debio 0123 RD along with TMZ in each 28-day cycle for up to 2 years.
Group II: Phase 1 (Dose Expansion): Debio 0123 + TemozolomideExperimental Treatment2 Interventions
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.
Group III: Phase 1 (Dose Escalation): Arm C - Debio 0123 + Temozolomide + RadiotherapyExperimental Treatment3 Interventions
Participants will receive intermittent Debio 0123, escalating doses along with TMZ and concomitant administration of radiotherapy (RT) for up to 6 weeks.
Group IV: Phase 1 (Dose Escalation): Arm B - Debio 0123 + Temozolomide + RadiotherapyExperimental Treatment3 Interventions
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.
Group V: Phase 1 (Dose Escalation): Arm A - Debio 0123 + TemozolomideExperimental Treatment2 Interventions
Participants will receive intermittent Debio 0123, escalating doses along with temozolomide (TMZ) in each 28-day cycle for up to 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiotherapy
2017
Completed Phase 3
~2610
Temozolomide
2010
Completed Phase 3
~1880
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Temozolomide is an oral chemotherapy drug that works by methylating DNA, which leads to DNA damage and triggers cell death in rapidly dividing tumor cells. Radiotherapy uses high-energy radiation to damage the DNA of cancer cells, inhibiting their ability to replicate and causing cell death.
Debio 0123 is being studied for its potential to enhance the effects of temozolomide and radiotherapy by possibly increasing the sensitivity of glioblastoma cells to these treatments. This combination aims to improve treatment efficacy, offering hope for better outcomes in glioblastoma patients, who typically face a poor prognosis with standard therapies.
Find a Location
Who is running the clinical trial?
Debiopharm International SALead Sponsor
51 Previous Clinical Trials
7,160 Total Patients Enrolled
Study DirectorStudy DirectorDebiopharm International SA
1,252 Previous Clinical Trials
504,247 Total Patients Enrolled
1 Trials studying Glioblastoma
116 Patients Enrolled for Glioblastoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been frequently exposed to a lot of sunlight.I have never been treated with a WEE1 inhibitor.I have had a condition where my lymphocytes grow abnormally.I have been treated with medications targeting blood vessel growth in cancer.I have not had radiation in the same area where I would receive it now.My seizures are under control with stable medication.I have had only one treatment for my Grade 4 GBM, IDH-wildtype cancer.I haven't had cancer in the last 5 years, except for skin cancer.I have a history of cancer.I am not allergic to Debio 0123, TMZ, dacarbazine, or their ingredients.I am mostly able to take care of myself.I have had treatments like radiation or chemotherapy for brain cancer.I am willing to provide a tumor sample if I have one.My diagnosis is Grade 4 GBM, IDH-wildtype, confirmed by tissue analysis.I stopped taking TMZ due to a blood-related issue during my combined chemo and radiation therapy.I've been on a stable or reducing dose of corticosteroids for the last week.I haven't had chemotherapy, biologics, experimental treatments, or radiation aimed at curing my condition in the last 28 days.My liver, kidneys, and bone marrow are working well.I am willing and able to follow the study's schedule and procedures.My brain tumor can be measured by MRI according to specific criteria.My diagnosis is either GBM IDH-wildtype Grade 4 or Astrocytoma IDH-mutant Grade 3.I have a confirmed diagnosis of Grade 4 GBM, IDH-wildtype.I've had over 2 treatments for a specific brain cancer type.I haven't needed active treatment for another cancer, except for certain low-risk types, in the last 2 years.I cannot have MRI scans with contrast due to allergies or other reasons.I am 18 years old or older.I can care for myself but may need occasional assistance.I've had up to 1 or 2 treatments, starting with TMZ and radiation.My cancer has returned or worsened, confirmed by a biopsy or brain MRI.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 (Dose Escalation): Arm A - Debio 0123 + Temozolomide
- Group 2: Phase 1 (Dose Escalation): Arm B - Debio 0123 + Temozolomide + Radiotherapy
- Group 3: Phase 1 (Dose Expansion): Debio 0123 + Temozolomide
- Group 4: Phase 1 (Dose Escalation): Arm C - Debio 0123 + Temozolomide + Radiotherapy
- Group 5: Phase 2: Debio 0123 RD + Temozolomide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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