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RecruitingPHASE1INTERVENTIONAL

A Study to Test How Well Different Doses of BI 3820768 Are Tolerated by People With Advanced Cancer (Solid Tumours)

This study is for adults with advanced germ cell, endometrial, or ovarian cancers that haven't responded to previous treatments, or if other treatments aren't suitable. We're testing a new medicine called BI 3820768. This is the first time it’s being used in people. The main goal is to find a dose that is safe and well-tolerated, and to see if it can shrink tumours. BI 3820768 works by helping your body's immune system fight cancer. Participants will receive the medicine by injection, either weekly or every three weeks, and stay in the study for up to three years if it's helping them. Doctors will carefully monitor their health and tumour size throughout.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Boehringer Ingelheim
Enrolment target
187
Start
27 Feb 2026
Estimated completion
31 Dec 2029

What is this study about?

This study is about a new medicine called BI 3820768, which is being tested for certain types of advanced cancer. These cancers include germ cell tumours, endometrial cancer (cancer of the womb lining), and ovarian cancer, especially if they have come back or haven't responded to earlier treatments. The study is for people who have tried other treatments without success, or for whom standard treatments are not an option.

The main aim of this study is to find the right dose of BI 3820768 that people can safely take. Since this is the first time this medicine is being given to humans, we need to be very careful in finding a dose that is not only safe but also shows signs of helping to shrink tumours. BI 3820768 is designed to help your body's own immune system become stronger in fighting cancer, which is a promising new way to treat these diseases.

Participants in the study will be given BI 3820768 through an injection. The specific way and how often you get the injection might depend on when you join the study. Generally, you would receive the medicine once a week for the first six weeks, and then every three weeks after that. This study is an important step in understanding if BI 3820768 could become a future treatment option for these specific cancers.

Key takeaways

  • This study tests a new cancer medicine (BI 3820768) for advanced germ cell, endometrial, and ovarian cancers.
  • It's a 'first-in-human' study, meaning the medicine hasn't been given to people before.
  • The main goal is to find a safe and tolerable dose, and to see if it makes tumours shrink.
  • The medicine works by boosting your immune system to fight cancer.
  • Participation involves regular clinic visits, injections, and careful health monitoring.
  • You can discuss this study with your doctor to see if it might be an option for you.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with advanced germ cell, endometrial, or ovarian cancer. This means your cancer has either come back or hasn't responded to previous treatments. For endometrial or ovarian cancer, your cancer cells must also have a specific marker that the new medicine targets. You should generally be well enough to take part in a study, meaning you can mostly look after yourself.

There are also some reasons why you might not be able to join. For example, if you've had major surgery very recently (within the last 28 days), or if you've had other cancers in the past three years (unless they were certain types of skin cancer or early-stage cervical or breast cancer that have been fully treated). People with serious infections or certain types of cancer spread to the brain or spinal cord would also not be able to participate. Your study doctor will check all these details carefully.

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 germ cell, endometrial, or ovarian cancer that has come back or not responded to previous treatment?
  3. Are you generally well enough to manage your daily activities?
  4. Have you not had major surgery in the last month?
  5. Do you not have a serious ongoing infection or certain types of cancer spread to the brain or spine?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study medicine, BI 3820768, through an injection. The injections will be given either once a week for six weeks, and then every three weeks after that. You might stay in the study for up to three years if the treatment is helping you. During this time, you will need to come to the study clinic regularly, and sometimes these visits might require you to stay overnight. Doctors will frequently check on your general health, take blood samples, and monitor the size of your tumours and whether the cancer has spread. They will also keep a close eye on any side effects you might experience. This helps them find the safest and most effective dose of the medicine.

Potential risks and benefits

Being part of this study means you could be among the first to receive a new medicine that might help fight your cancer, especially if other treatments haven't worked. However, because BI 3820768 is new, there could be unknown side effects or it might not help your cancer. As with any medicine, there is a risk of side effects, which doctors will monitor closely. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

  • Valkyrie Clinical Trials
    Verified postcode
    Los Angeles, United States· Recruiting
  • Indiana University
    Verified postcode
    Indianapolis, United States· Not yet recruiting
  • The University of Texas MD Anderson Cancer Center
    Verified postcode
    Houston, United States· Not yet recruiting
  • Cliniques Universitaires Saint-Luc
    Verified postcode
    Brussels, Belgium· Not yet recruiting
  • UZ Leuven
    Verified postcode
    Leuven, Belgium· Suspended
  • INS Paoli-Calmettes
    Verified postcode
    Marseille, France· Not yet recruiting
  • Institut Gustave Roussy
    Verified postcode
    Villejuif, France· Not yet recruiting
  • Klinikum der Universität München AÖR
    Verified postcode
    München, Germany· Not yet recruiting
  • Universitätsklinikum Würzburg AÖR
    Verified postcode
    Würzburg, Germany· Not yet recruiting
  • National Cancer Center Hospital East
    City only
    Chiba, Kashiwa, Japan· Not yet recruiting
  • Japanese Foundation for Cancer Research
    City only
    Tokyo, Koto-ku, Japan· Not yet recruiting
  • Hospital Universitari Vall d'Hebron
    Verified postcode
    Barcelona, Spain· Not yet recruiting

Common questions

What is BI 3820768?

It's a new medicine being tested in this study that aims to help your body's immune system fight cancer.

What types of cancer is this study for?

It's for advanced germ cell tumours, endometrial cancer, and ovarian cancer that have not responded to previous treatments.

How will the medicine be given?

The medicine will be given as an injection, either weekly or every three weeks, depending on the stage of the study.

How long will I be in the study?

You could be in the study for up to three years, as long as the treatment is helping you.

Will I have to stay overnight for appointments?

Some of your regular study visits may require an overnight stay at the clinic.

How to find out more

Boehringer Ingelheim

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Test How Well Different Doses of BI 3820768 Are T…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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