RecruitingRare disease

Study of Debio 0123 and Temozolomide for Adults with Recurrent or Newly Diagnosed Glioblastoma

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of brain cancer called glioblastoma. The study involves two main treatments: a medication known as Debio 0123 and another medication called temozolomide. In some cases, these medications are used together with radiotherapy, which is a treatment that uses high-energy rays to target cancer cells. The purpose of the study is to understand how safe and tolerable Debio 0123 is when used with temozolomide, and to determine the best dose for further research. Additionally, the study aims to assess how effective Debio 0123 is when combined with temozolomide compared to the usual treatment options.

Participants in the study will receive either Debio 0123 with temozolomide or Debio 0123 with temozolomide and radiotherapy. The study will be conducted in phases, starting with a focus on safety and the best dose, and then moving on to evaluate how well the treatment works. Throughout the study, participants will be monitored for any side effects and changes in their health. The study will also look at how the medications are processed in the body, which is known as their pharmacokinetic profile. This includes measuring how much of the drug is in the blood at different times and how long it stays in the body.

The study is expected to continue for several years, with the goal of gathering enough information to determine if Debio 0123 can be a beneficial treatment option for people with glioblastoma. Participants will undergo regular health checks, including magnetic resonance imaging (MRI) scans, to monitor the progress of their condition and the effects of the treatment. The study will help researchers understand more about glioblastoma and potentially improve treatment options for this challenging disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit where you will receive detailed information about the trial. This includes understanding the purpose, procedures, and potential risks and benefits.
You will be asked to sign a consent form, confirming your willingness to participate and comply with the study requirements.
Step 2
Treatment phase 1
In the first phase of treatment, you will receive a combination of Debio 0123 and temozolomide. The specific dosage and frequency will be determined by the study team based on your individual needs.
This phase aims to assess the safety and tolerability of the medication combination. Regular monitoring will be conducted to observe any side effects or changes in your condition.
Step 3
Treatment phase 2
If you are newly diagnosed with glioblastoma, you may receive Debio 0123 in combination with temozolomide and radiotherapy. This phase focuses on evaluating the effectiveness of the treatment.
You will continue to be monitored closely, with adjustments made to your treatment plan as necessary.
Step 4
Regular assessments
Throughout the trial, you will undergo regular assessments, including blood tests, imaging scans, and other evaluations to track your response to the treatment.
These assessments help ensure your safety and provide valuable data for the study.
Step 5
Follow-up visits
After completing the treatment phases, you will have follow-up visits to monitor your health and any long-term effects of the treatment.
These visits are crucial for understanding the overall impact of the study medications on your condition.

Who can join the trial?

17 criteria

Must sign a written consent form before any study procedures begin.
Must be willing and able to attend scheduled visits, follow treatment plans, and undergo tests and procedures.
For Phase 1 Arm A: Must have a confirmed diagnosis of either GBM IDH-wildtype, Grade 4 or Astrocytoma, IDH-mutant, Grade 3.
For Phase 1 Arm B/C: Must have a new confirmed diagnosis of GBM, IDH-wildtype, Grade 4.
For Phase 1 Arm A/dose expansion and Phase 2: Can have had a maximum of 1 or 2 previous treatments, with the first being TMZ-based chemoradiotherapy (a combination of chemotherapy and radiation therapy).
For Phase 1 Arm A/dose expansion and Phase 2: Must have documented disease recurrence or progression confirmed by a biopsy or MRI scan.
For Phase 1 Arm A/dose expansion and Phase 2: Must have a Karnofsky Performance Status (KPS) score of 60 or higher. This score measures the ability to perform daily activities.
For Phase 1 Arm B/C: Must have a Karnofsky Performance Status (KPS) score of 70 or higher.
For Phase 1 dose expansion and Phase 2: Must have a confirmed diagnosis of GBM, IDH-wildtype, Grade 4.
Must be 18 years of age or older.
Must be willing to provide a tumor sample, if available. The sample is not required to start the study treatment.
Must have adequate bone marrow, liver, and kidney function.
Must have a life expectancy of at least 3 months, as judged by the study doctor.
If taking corticosteroids (a type of medication), the dose must be stable or decreasing, and not more than 4 mg of dexamethasone (or 25 mg of prednisone) daily for 7 days before starting the study treatment.
If experiencing seizures, they must be well-controlled with a stable dose of anti-seizure medication.
Must have measurable or non-measurable disease as determined by an MRI scan.
Must be willing to use highly effective methods of contraception.

Who cannot join the trial?

10 criteria

Patients with any other active cancer besides glioblastoma cannot participate.
Patients who have had another cancer in the past, unless it was treated and has not come back for at least 5 years, are excluded.
Patients with serious heart problems, such as heart failure or a recent heart attack, are not eligible.
Patients with uncontrolled high blood pressure cannot join the study.
Patients with severe liver or kidney disease are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have had a major surgery within the last 4 weeks are not eligible.
Patients who are currently participating in another clinical trial are excluded.
Patients with known allergies to the study drugs or similar drugs cannot join.
Patients with any condition that the study doctors believe would make it unsafe for them to participate are not eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Universitario 12 De Octubre
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Madrid, Spain
Hospital Universitario De Navarra
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Pamplona, Spain
Hospital Universitario Donostia
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Donostia / San Sebastian, Spain

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Investigated drugs

Debio 0123
is an experimental medication being tested in this clinical trial. It is being studied to see how safe and tolerable it is when used with other treatments for glioblastoma, a type of brain cancer. Researchers are trying to find the best dose of Debio 0123 to use in combination with other therapies. The goal is to see if it can help improve treatment outcomes for patients with both newly diagnosed and recurrent glioblastoma.
Temozolomide
is a medication that is already used to treat certain types of brain cancer, including glioblastoma. It works by damaging the DNA of cancer cells, which can help stop them from growing and spreading. In this trial, temozolomide is being used in combination with Debio 0123 to see if the two medications together can be more effective than temozolomide alone.
Radiotherapy
is a common treatment for cancer that uses high-energy rays to kill cancer cells. In this trial, radiotherapy is being used alongside Debio 0123 and temozolomide for patients with newly diagnosed glioblastoma. The aim is to see if adding Debio 0123 to the standard treatment of radiotherapy and temozolomide can improve the effectiveness of the treatment.

What is already known about the treatment

Debio 0123 – Debio 0123 is an investigational medication currently being studied in clinical trials for its potential use in treating glioblastoma, a type of brain cancer. It is administered in combination with another drug called temozolomide, and sometimes with radiotherapy, to evaluate its safety, tolerability, and effectiveness. The main goal is to determine the best dose for further research and to see how well it works compared to standard treatments. Debio 0123 works at the molecular level by targeting specific pathways in cancer cells to inhibit their growth and survival. It is classified as an experimental cancer therapy, and its use is still under investigation in medical research.

Investigated diseases

Glioblastoma – Glioblastoma is an aggressive type of cancer that occurs in the brain or spinal cord. It originates from astrocytes, which are cells that support nerve cells. The disease progresses rapidly, as the tumor cells grow quickly and can invade nearby brain tissue. Glioblastomas can cause a variety of symptoms, including headaches, nausea, seizures, and neurological deficits, depending on the tumor's location. As the tumor grows, it can lead to increased pressure within the skull, further exacerbating symptoms. The progression of glioblastoma is marked by its ability to infiltrate surrounding brain tissue, making it challenging to manage.