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Study of NMS-03305293 and Temozolomide for Adults with Recurrent 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 recurrent glioblastoma. The study is testing a new treatment that combines two medications: NMS-03305293 and temozolomide. The purpose of the study is to find the best dose of NMS-03305293 when used with temozolomide and to see how effective this combination is in treating glioblastoma that has come back after initial treatment.

Participants in the study will take the medications in the form of hard capsules, which are swallowed. The study will be conducted in two phases. In the first phase, researchers will determine the safest and most effective dose of NMS-03305293 when combined with temozolomide. In the second phase, the study will evaluate how well this combination works in shrinking the tumor or stopping its growth in patients with a specific type of glioblastoma known as IDH wild type.

Throughout the study, participants will have regular check-ups, including MRI scans, to monitor the tumor's response to the treatment. The study will also assess the overall safety of the medication combination by tracking any side effects experienced by participants. The trial aims to provide valuable information on the potential benefits of combining NMS-03305293 with temozolomide for treating recurrent glioblastoma.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, eligibility is confirmed based on specific criteria, including a confirmed diagnosis of recurrent glioblastoma and the ability to swallow capsules intact.
Participants must agree to use effective contraception or abstinence during the study and for a specified period after discontinuation of treatment.
Step 2
Initial assessment
An initial assessment is conducted, including a brain MRI scan to confirm measurable disease and to ensure no symptomatic and acute intratumoral hemorrhage is present.
Baseline laboratory tests are performed to ensure all acute toxic effects from prior treatments are resolved to acceptable levels.
Step 3
Treatment phase i
The first phase of treatment involves determining the maximum tolerated dose of the experimental drug NMS-03305293 in combination with temozolomide.
Participants receive temozolomide in the form of hard capsules, with dosages of 5 mg, 20 mg, or 140 mg, taken orally as prescribed by the study protocol.
Step 4
Treatment phase ii
In the second phase, the focus is on assessing the antitumor efficacy of the combination treatment in patients with specific genetic characteristics of glioblastoma.
The treatment continues with the same medications, and the response to treatment is monitored through regular assessments.
Step 5
Monitoring and follow-up
Throughout the study, participants undergo regular monitoring, including brain MRI scans and laboratory tests, to assess the safety and effectiveness of the treatment.
The study aims to evaluate the overall safety profile, including any adverse events and their relationship to the study treatment.
Step 6
Completion
Upon completion of the study, participants may undergo a final assessment to evaluate the long-term effects of the treatment.
The study is estimated to conclude by December 15, 2025.

Who can join the trial?

16 criteria

Patients must have a confirmed diagnosis of a type of brain tumor called **diffuse glioma**. This includes types like diffuse astrocytoma, oligodendroglioma, or glioblastoma.
Patients must be at their first relapse, meaning the tumor has returned after initial treatment.
Patients must be able to swallow capsules whole, without chewing or crushing them.
Patients must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests and procedures.
Patients must have a life expectancy of at least 3 months.
Patients must be able to undergo brain scans called **MRI** with a special dye called **gadolinium**.
Patients must not have any new or worsening bleeding inside the tumor, as shown on an MRI scan.
Patients must have enough tissue available for specific tests related to the tumor.
Patients must be 18 years or older.
Patients must have a certain level of physical ability, measured by a scale called **ECOG performance status**, which should be 2 or less. This means they can do most daily activities but may need some help.
Patients must have signed a consent form agreeing to participate in the study.
Patients must have recovered from any side effects of previous cancer treatments to a certain level, except for hair loss.
Patients must have certain baseline laboratory test results that meet the study's requirements.
Patients must use highly effective birth control methods or practice true abstinence during the study and for a specified time after stopping the study treatment. This is important because the study drug might affect the effectiveness of hormonal birth control.
Patients on steroids must have a stable or decreasing dose for 7 days before the baseline MRI scan.
For patients who have had surgery for tumor recurrence, the surgery must have been completed at least 2 weeks before joining the study, and their condition should not have worsened since the surgery.

Who cannot join the trial?

6 criteria

Patients who have not experienced a return of their brain tumor, known as recurrent glioblastoma, cannot participate.
Patients who have not had their brain tumor come back for the first time, referred to as first relapse, are excluded.
Patients who do not have a specific type of brain tumor called isocitrate dehydrogenase (IDH) wild type glioblastoma are not eligible.
Patients who are not within the specified age range for the study cannot join.
Patients who are not able to safely tolerate the study medication, known as Maximum Tolerated Dose (MTD), are excluded.
Patients who are not suitable for the recommended dose for the next phase of the study, called Recommended Phase 2 Dose (RP2D), cannot participate.

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Verified sites

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

Verified
Azienda Unita Sanitaria Locale Di Bologna
Bologna, Italy
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Istituto Oncologico Veneto
Padua, Italy

Trial locations

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Investigated drugs

NMS-03305293
is an investigational medication being studied for its potential to treat recurrent glioblastoma, a type of brain cancer. In this clinical trial, researchers are trying to find the best dose of this medication when used in combination with another drug. They are also looking at how well it works in treating the cancer.
Temozolomide
is a chemotherapy drug that is commonly used to treat certain types of brain tumors, including glioblastoma. In this study, it is being combined with NMS-03305293 to see if the combination is more effective in treating recurrent glioblastoma than using temozolomide alone.

What is already known about the treatment

NMS-03305293
This medication is administered orally and is currently being studied in clinical trials for its potential use in treating recurrent glioblastoma, a type of brain cancer. It is in the experimental phase, with ongoing research to determine its safety and effectiveness. The main therapeutic indication is for patients with glioblastoma that has returned after initial treatment. At the molecular level, NMS-03305293 works by targeting specific pathways involved in cancer cell growth and survival. It is classified as an investigational anticancer agent.
Temozolomide
This medication is taken orally and is an established treatment for certain types of brain tumors, including glioblastoma. It is widely recognized in medical literature and is used to treat recurrent glioblastoma, often in combination with other therapies. Temozolomide works by damaging the DNA of cancer cells, which prevents them from dividing and growing. It is classified as an alkylating agent, a type of chemotherapy drug.

Investigated diseases

Recurrent Glioblastoma – Recurrent glioblastoma is a type of brain tumor that originates from the supportive tissue of the brain. It is characterized by its aggressive nature and tendency to grow rapidly. This tumor often returns after initial treatment, which is why it is termed "recurrent." As it progresses, it can cause symptoms such as headaches, seizures, and neurological deficits depending on its location in the brain. The tumor's growth can lead to increased pressure within the skull, affecting brain function. Recurrent glioblastoma is known for its ability to infiltrate surrounding brain tissue, making it challenging to manage.