All studies
RecruitingPHASE1INTERVENTIONAL

A Study to Test How Different Doses of BI 1703880 in Combination With Ezabenlimab Are Tolerated in People With Different Types of Advanced Cancer (Solid Tumours)

This study is for adults with different types of advanced cancer where previous treatments haven't been successful or there are no other options. The main goal is to find out the highest safe dose of a new medicine, BI 1703880, when given together with another medicine called ezabenlimab. These medicines are designed to help your body's immune system fight cancer. Participants will receive both drugs through an IV, with the frequency of doses changing initially. Doctors will regularly check their health and any side effects. This is the first time BI 1703880 is being given to people, so researchers are carefully monitoring its effects. Participants can receive treatment for up to two years, as long as it's helping and they are tolerating it well.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Boehringer Ingelheim
Enrolment target
66
Start
24 Feb 2023
Estimated completion
13 Sep 2028

What is this study about?

This study is for adults who have different types of advanced cancer, also known as solid tumours, where standard treatments haven't worked or there aren't any other suitable options. The main purpose is to explore new treatments called BI 1703880 and ezabenlimab. Scientists believe these medicines might help your body's natural defense system, your immune system, to fight cancer cells more effectively. This is a very early-stage study (Phase 1), which means it's the first time BI 1703880 is being given to people. \n\nThe most important first step is to find the right amount, or dose, of BI 1703880 that people can safely take alongside ezabenlimab. Finding this safe dose is crucial before more people can take the medicine in future studies. The researchers will also be carefully watching to see if these medicines have any positive effects on the cancer and how well people tolerate them. \n\nBy taking part, you would be contributing important information that could help develop new cancer treatments for the future. It's a way to explore new possibilities when other treatments haven't been successful.

Key takeaways

  • This study explores new treatments for advanced solid tumours.
  • It's for adults whose previous treatments haven't worked or who have no other options.
  • The goal is to find a safe dose of new immune-boosting medicines.
  • You would receive regular infusions and have frequent health check-ups.
  • Participation could last up to two years, if the treatment is beneficial.
  • You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have an advanced solid tumour. This means the cancer may have spread or cannot be removed by surgery. You would need to have already tried or not be able to have standard cancer treatments.\n\nYou would also need to be generally well enough to take part in all the study activities. Doctors will check various health markers, like blood test results and how active you are, to make sure it's safe for you. You would also need to agree to have a small tissue sample (biopsy) taken before and during the study.\n\nThere are specific medical checks the doctors will perform, including looking at your blood counts, kidney, and liver function. These checks are to ensure your body is healthy enough for the new medicines and to keep you safe throughout the study. Having a 'lesion' that doctors can measure is also important, so they can see if the treatment is having an effect.

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 an adult aged 18 or older?
  2. Do you have an advanced type of solid tumour?
  3. Have you tried other cancer treatments that haven't worked, or are there no other options for you?
  4. Are you generally well and active enough for daily tasks?
  5. Are you willing to have small tissue samples (biopsies) taken?
  6. Are your blood test results (like blood counts, kidney, and liver function) generally within a healthy range?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive two medicines, BI 1703880 and ezabenlimab, through a drip into a vein (infusion). For the first six weeks, you will get BI 1703880 once a week. After that, you'll receive BI 1703880 every three weeks. Ezabenlimab will be added to your treatment every three weeks starting from the fourth week.\n\nTreatment with BI 1703880 can last for up to one year, and ezabenlimab for up to two years, as long as the treatment seems to be helping you and you are not experiencing severe side effects. Throughout this time, you'll have regular visits to the study clinic. During these visits, the medical team will closely monitor your health, perform necessary tests, and record any side effects you might experience. They will also repeatedly check your cancer to see how it's responding to the treatment.

Potential risks and benefits

Taking part in a new drug study like this means there's a chance the treatment might help your cancer, especially since other options haven't worked. However, because these are new medicines, particularly BI 1703880, it's not known what all the side effects might be. There could be mild side effects, or more serious ones. The medical team will monitor you very closely to manage any issues quickly. It's important to remember that you can choose to leave the study at any time, for any reason, without it affecting your future medical care.

Locations (13)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Valkyrie Clinical Trials
    Verified postcode
    Los Angeles, United States· Recruiting
  • Yale University School of Medicine
    Verified postcode
    New Haven, United States· Recruiting
  • John Theurer Cancer Center
    Verified postcode
    Hackensack, United States· Recruiting
  • National Cancer Center Hospital East
    Unverified
    Chiba, Kashiwa, Japan· Recruiting
  • Saitama Medical University International Medical Center
    Unverified
    Saitama, Hidaka, Japan· Not yet recruiting
  • Japanese Foundation for Cancer Research
    Unverified
    Tokyo, Koto-ku, Japan· Recruiting
  • Hospital Universitari Vall D Hebron
    Verified postcode
    Barcelona, Spain· Recruiting
  • CIO Clara Campal
    Verified postcode
    Madrid, Spain· Recruiting
  • Instituto Valenciano de Oncología
    Verified postcode
    Valencia, Spain· Recruiting
  • Hospital Clinico Universitario De Valencia
    Verified postcode
    Valencia, Spain· Recruiting
  • The Royal Marsden Hospital, Chelsea
    Verified postcode
    London, United Kingdom· Recruiting
  • Churchill Hospital
    Verified postcode
    Oxford, United Kingdom· Recruiting

Common questions

What kind of cancer is this study for?

This study is for adults with different types of advanced solid tumours, which means cancers that have spread or can't be removed by surgery.

What are the new medicines called?

The new medicines being tested are called BI 1703880 and ezabenlimab.

How will I receive the medicines?

You will receive both medicines as regular infusions (drips) into a vein.

How long will I be on the treatment?

You could be on BI 1703880 for up to one year and ezabenlimab for up to two years, as long as it's helping and you tolerate it well.

Why is this study being done?

It's being done to find the safest dose of BI 1703880 when given with ezabenlimab, and to see if these medicines can help your immune system fight cancer.

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 Different Doses of BI 1703880 in Combina…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.