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

1 1 1 1

What is this study about?

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.

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

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

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Aix Marseille University Marseille France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Comite Entreprise Paul Papin Angers France
Centre Hospitalier Universitaire De Lille Lille France
Institut Curie – Site Paris Paris France

Other Sites

Site Name City Country Status
Hopitaux Universitaires Pitie Salpetriere Paris France
Centre Hospitalier Lyon Sud Pierre Benite France
Cyfgee Lzry Bstyyq Lyon France
Csfgvd Hfoytnjjcyf Rmcdbzhm Dlzobkkezkgetk Angers France
Cthmfp Ovwkj Lseqgkm Lille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
30.09.2025

Trial locations

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.

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.

Trial ID:
2023-510568-11-00
Protocol code:
ET23-040
NCT ID:
NCT07243470
Trial Phase:
Human Pharmacology (Phase I) – Other

Other Trials to Consider

  • Study on Antibiotics Amoxicillin, Clavulanic Acid, Ciprofloxacin, and Drug Combination for Children with Malignant Brain Tumors

    Recruiting

    1 1 1 1
    Investigated diseases:
    Austria
  • Study on Lithium Sulphate to Prevent Cognitive Impairment in Children After Brain Tumor Radiotherapy

    Recruiting

    2 1 1
    Investigated drugs:
    Denmark Sweden