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Study of Tarlatamab and Temozolomide combination treatment in adolescents and adults with high grade brain tumors

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What is this trial about?

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

This clinical trial focuses on treating patients with high grade brain tumors using a combination of two medications. The study will test Tarlatamab (also known as AMG 757), which is given through an intravenous infusion, together with Temozolomide, which is taken by mouth. These medications will be used to treat different types of brain tumors, including those with specific genetic changes.

The purpose of this study is to determine if this combination of medications is safe to use and to evaluate how well it works in treating brain tumors. The study is divided into two parts. The first part will check the safety of combining these medications, while the second part will look at how effective this treatment is in different groups of patients with various types of brain tumors.

During the study, patients will receive both medications according to a specific schedule. Tarlatamab will be given as an infusion into a vein, while Temozolomide will be taken as regular oral doses. The treatment will continue while patients are benefiting from it and not experiencing unacceptable side effects. Doctors will monitor patients' responses to the treatment using brain scans and regular health checks throughout the study period.

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 medical assessment
You will undergo tests to confirm that your tumor expresses DLL3 through tissue analysis
Your doctor will evaluate your general health status and verify that you meet all medical criteria, including heart, lung, kidney, and liver function
A pregnancy test will be required if you are a woman who can become pregnant
Step 2
Treatment preparation
You must stop any previous cancer treatments with specific waiting periods:
3 months after last bevacizumab treatment
21 days after most chemotherapy treatments
42 days after cellular therapy
14 days after local radiation therapy
84 days after large-field radiation therapy
Step 3
Treatment phase
You will receive two medications:
Tarlatamab through intravenous infusion
Temozolomide taken by mouth daily at a fixed dose
The treatment will be organized in cycles
The first 8-12 weeks will be closely monitored for any side effects
Step 4
Monitoring
Your tumor response will be evaluated at 12 weeks using brain imaging
Regular assessments of your health status will continue throughout the treatment
Blood tests will be performed to monitor your body's response to treatment
Step 5
Follow-up period
After completing treatment, you must use effective birth control for 6 months
Your health will continue to be monitored to assess the long-term effects of treatment
Regular imaging will be performed to check your tumor status

Who can join the trial?

17 criteria

Must be at least 12 years old
Must have a confirmed diagnosis of brain tumor that has been proven through tissue examination
The tumor must show specific protein markers (DLL3) when tested
Must have disease that has gotten worse after receiving at least one standard treatment that included radiation therapy
Must have tumor(s) that can be measured by brain imaging
Must have good physical functioning ability (performance status) as measured by standard scales
Must have a life expectancy of at least 3 months
Must have adequate blood cell counts: - Sufficient white blood cells - Sufficient platelets - Sufficient hemoglobin (a protein that carries oxygen in blood)
Must have proper kidney and liver function as shown by blood tests
Must have good heart function with a heart pumping strength of at least 50%
Must have good lung function and no significant fluid around the lungs
Must provide a tumor tissue sample that contains at least 30% tumor cells
Must stop all previous cancer treatments for specific periods before starting the study
Women who can become pregnant must have a negative pregnancy test and use effective birth control
Men must agree to use appropriate birth control during the study and for 6 months after
Must be able to understand and sign the consent form
Must have medical insurance

Who cannot join the trial?

15 criteria

Age below 12 years old
Pregnant or breastfeeding women
Previous severe allergic reactions to similar treatments
Active uncontrolled infections
Serious heart conditions or uncontrolled high blood pressure
Severe liver problems (as indicated by blood tests showing liver dysfunction)
Severe kidney problems (as shown by reduced kidney function in blood tests)
Active treatment with certain medications that might interact with the study drug
Participation in another clinical trial within the last 30 days
Inability to follow study procedures or attend scheduled visits
History of another cancer in the past 5 years (except for successfully treated non-melanoma skin cancer)
Mental conditions that could interfere with giving informed consent
Severe blood disorders affecting blood cell counts
History of certain neurological conditions that might affect the assessment of the treatment
Unstable medical conditions that could worsen during the study

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Verified sites

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

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Centre Hospitalier Lyon Sud
Pierre Benite, France
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Centre Hospitalier Regional D'Angers
Angers, France
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Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France

Trial locations

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Investigated drugs

Tarlatamab is a newer medication being studied for treating brain tumors. It belongs to a class of treatments that target specific proteins on cancer cells. This medication is being tested in combination with another drug to see if together they can help patients with various types of brain tumors. Temozolomide is an established chemotherapy medication used to treat brain tumors. It works by damaging the DNA of cancer cells, which helps to stop them from growing and dividing. In this trial, it is being given in a "metronomic" way, which means in a regular, frequent schedule at lower doses. The combination of these two medications is being tested to see if they work better together than either medication alone in treating different types of brain tumors, particularly in adolescents and adults.

What is already known about the treatment

Tarlatamab
An investigational bispecific antibody medication being studied in clinical trials for the treatment of high-grade brain tumors. It is administered intravenously and is being tested in combination with temozolomide for central nervous system tumors. The medication is currently in Phase I/II clinical trials to evaluate its safety and clinical effectiveness in adolescents and adults.
Temozolomide
An oral chemotherapy medication used in the treatment of specific types of brain tumors, particularly high-grade gliomas. It works by damaging the DNA of cancer cells, preventing them from dividing and growing, and belongs to the alkylating agents class of anti-cancer drugs. When used in a metronomic dosing schedule, it involves regular administration of lower doses to maintain continuous anti-tumor activity while potentially reducing side effects.

Investigated diseases

High-grade brain tumor - A condition where abnormal cells grow rapidly in brain tissue, forming masses that can affect various brain functions. These tumors develop from brain cells or supporting tissues and tend to grow more aggressively than low-grade tumors. They can occur in different parts of the brain and may cause symptoms such as headaches, seizures, and changes in cognitive function. The tumor cells can spread within the brain tissue and may affect nearby structures. These tumors can cause pressure inside the skull as they grow, leading to various neurological symptoms depending on their location.