All studies
Active not recruitingPHASE1INTERVENTIONAL

DAREON™-7: A Study to Test How Well Different Doses of BI 764532 in Addition to Chemotherapy Are Tolerated by People With Advanced Neuroendocrine Cancers

This study is for adults with advanced neuroendocrine cancer that has a marker called DLL3. Researchers are testing a new medicine, BI 764532, alongside standard chemotherapy. The main goals are to find the safest doses of BI 764532 when given with chemotherapy and to see how well patients tolerate this combination. They also want to understand if this new treatment helps shrink or control the cancer. Participants will receive the new medicine and chemotherapy through a drip and will have regular check-ups to monitor their health, side effects, and tumour size. The study could last up to three years for those who benefit.

At a glance

Status
Active not recruiting
Phase
PHASE1
Sponsor
Boehringer Ingelheim
Enrolment target
55
Start
22 Jan 2024
Estimated completion
25 Apr 2027

What is this study about?

This study, called DAREON™-7, is looking at a new treatment approach for specific types of advanced neuroendocrine cancers (NECs). Neuroendocrine cancers are a group of uncommon cancers that start in specialised cells in the body. 'Advanced' means the cancer has spread from where it started. Scientists are testing a new medicine called BI 764532, which works by targeting a specific marker on cancer cells called DLL3. This study aims to combine BI 764532 with standard chemotherapy treatments to see if this combination is safe and effective.

The study is divided into different parts. In the first parts (A1 and A2), researchers want to find the highest safe dose of BI 764532 that can be given with chemotherapy to patients. In a later part (B), they will explore how well patients tolerate BI 764532 when given with slightly different chemotherapy drugs. The overall goal is to understand if this new combination treatment can help people with these specific neuroendocrine cancers that have the DLL3 marker.

Finding new and effective treatments for advanced cancers is very important. This study helps doctors understand how a new drug works alongside existing treatments. The information gathered might lead to better treatment options for patients in the future.

Key takeaways

  • This study is for adults with advanced neuroendocrine cancer with a specific marker (DLL3).
  • It tests a new medicine (BI 764532) in combination with chemotherapy.
  • The main goals are to find safe doses and see if the new treatment helps patients.
  • Treatment is given through a drip and can last up to 3 years if beneficial.
  • Regular hospital visits are required to monitor health and treatment effectiveness.

Who may be eligible?

This study is for adults aged 18 or older with certain types of advanced neuroendocrine cancer. To be considered, your cancer cells must have a specific marker called DLL3. Your cancer must also be considered 'locally advanced' (meaning it has spread nearby) or 'metastatic' (meaning it has spread to other parts of the body).

Doctors will also check your general health and how well you can perform daily activities. You would need to have at least one measurable area of cancer that can be tracked. If you have had brain involvement from your cancer that doesn't cause symptoms, you might still be eligible after your doctors confirm it's stable.

However, you cannot take part if you have previously been in this specific trial, are already in another trial, or have been in one within the last 30 days. Certain types of neuroendocrine cancer, like Merkel cell or medullary thyroid cancer, are not included. You also cannot join if you have received certain treatments targeting DLL3 in the past.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have advanced neuroendocrine cancer (NEC)?
  3. Has your doctor confirmed your cancer has the DLL3 marker?
  4. Are you generally in good health and able to move around well?
  5. Are you not currently involved in another medical study or have finished one over 30 days ago?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new medicine, BI 764532, and chemotherapy. Both medicines are given through a drip directly into a vein. The treatment may continue for up to three years, as long as you are benefiting from it and can manage any side effects.

You will need to visit the hospital or clinic regularly for check-ups. During these visits, the doctors and nurses will monitor your health closely, check for any unwanted effects from the treatment, and regularly measure the size of your cancer to see how the treatment is working. They will also collect blood samples and perform other tests to keep track of your progress.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to a new treatment that isn't widely available yet, which could help control your cancer. However, there are also potential risks, as all medicines can have side effects. Doctors will closely monitor you to manage any side effects. Remember, joining a clinical trial is a personal choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (20)

  • University of Miami
    Verified postcode
    Miami, United States
  • Winship Cancer Institute
    Verified postcode
    Atlanta, United States
  • Northwestern University
    Verified postcode
    Chicago, United States
  • John Theurer Cancer Center
    Verified postcode
    Hackensack, United States
  • University of Pittsburgh Medical Center
    Verified postcode
    Pittsburgh, United States
  • Cliniques Universitaires Saint-Luc
    Verified postcode
    Brussels, Belgium
  • Hôpital Louis Pradel
    Verified postcode
    Bron, France
  • INS Paoli-Calmettes
    Verified postcode
    Marseille, France
  • Klinikum der Universität München AÖR
    Verified postcode
    München, Germany
  • Universitätsklinikum Tübingen
    Verified postcode
    Tübingen, Germany
  • Aichi Cancer Center Hospital
    City only
    Aichi, Nagoya, Japan
  • National Cancer Center Hospital East
    City only
    Chiba, Kashiwa, Japan

Common questions

What is neuroendocrine cancer?

Neuroendocrine cancer is a rare type of cancer that starts in specialised cells called neuroendocrine cells, which are found throughout the body.

What does 'advanced' cancer mean?

'Advanced' means the cancer has grown or spread from where it first started, either to nearby tissues or to other parts of the body.

What is DLL3?

DLL3 is a specific marker that can be found on some cancer cells. The new medicine being tested in this study is designed to target cells with this marker.

What are infusions?

Infusions mean the medicine is given slowly into your bloodstream, usually through a small tube inserted into a vein, often in your arm.

Can I stop participating in the study?

Yes, you can choose to leave the study at any time. Your decision will not affect your usual medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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