Active not recruitingPHASE1, PHASE2INTERVENTIONAL

BI-1910 as a Single Agent and in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors

This research study is looking at a new treatment called BI-1910, sometimes on its own and sometimes combined with another medicine, pembrolizumab. It's for adults with advanced solid tumours, such as some types of lung cancer or liver cancer, where their current treatment hasn't worked or they can't have it. The main goals are to understand how safe BI-1910 is, find the best dose to use, and see if it helps to shrink tumours or slow their growth. Participants will receive the study medicines through infusions every three weeks. This is an early-stage study, meaning it's one of the first times this new medicine is being tested in people.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

BioInvent International AB

Enrolment target

Start

04 Dec 2023

Estimated completion

07 Nov 2028

Solid Tumors Non Small Cell Lung Cancer Hepatocellular Carcinoma

What is this study about?

This study is looking into a new medicine called BI-1910. We want to find out if it's a safe and helpful treatment for people with certain types of advanced solid tumours, which are cancers that start in organs and have spread. We're testing BI-1910 in two ways: by itself and in combination with another widely used cancer drug called pembrolizumab. This is for people whose cancer has continued to grow despite standard treatments, or for those who can't take the usual treatments. Conditions like non-small cell lung cancer and hepatocellular carcinoma (a type of liver cancer) are specifically mentioned.

The study has two main parts, called Phase 1 and Phase 2. Phase 1 is mainly about safety: finding out what dose of BI-1910 is safe to give, both on its own and with pembrolizumab. Once we understand the best dose, Phase 2 will then look more closely at how effective the treatment is at shrinking tumours or stopping them from growing, while still keeping a close eye on safety.

Taking part would involve regular visits and receiving the study drugs through an infusion, typically every three weeks. The overall aim is to gather important information about this new medicine that could potentially help patients in the future. We want to understand how it works in the body, its side effects, and if it shows promise in fighting cancer. This information is crucial for developing new and better ways to treat cancer.

Key takeaways

This study is testing a new cancer medicine, BI-1910, for advanced solid tumours.
It aims to find safe doses and see if the treatment helps shrink or slow cancer.
The study includes a known drug, pembrolizumab, in some treatment arms.
It's for people whose cancer hasn't responded to standard treatments or can't receive them.
Participation involves regular clinic visits and infusions every three weeks.

Who may be eligible?

To join this study, you would need to be 18 years or older and have a confirmed advanced solid tumour. Your cancer should have either gotten worse despite standard treatments, or you can't have those treatments for some reason. The doctors would need to be able to measure your tumour, and you'd need to be well enough to take part and have a good enough life expectancy (at least 12 weeks).

You would not be able to join if you need to take high doses of certain steroid medications, if your cancer has spread to your brain or spinal cord in an active way, or if you've had a bad reaction to BI-1910 or pembrolizumab before. There are also specific timeframes you need to have waited after receiving other cancer treatments like chemotherapy, radiotherapy, or immunotherapy before you can start this study. You also shouldn't have had certain serious side effects in the past, especially related to the immune system or from previous immunotherapy.

The study team will check your overall health, including your organ function, with tests to make sure it's safe for you to participate.

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.

Are you 18 years old or older?
Do you have an advanced solid tumour that has been diagnosed by a doctor?
Has your cancer progressed despite standard treatments, or can you not have those treatments?
Are you able to attend regular clinic appointments and receive infusions?
Do you have a general good health status as assessed by your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medication, BI-1910, either alone or combined with pembrolizumab. Both medicines are given through an infusion (into a vein). These infusions will happen every three weeks. The study will involve regular visits to the clinic for these infusions, as well as blood tests, physical examinations, and scans to check your health and how the treatment is working. You might also be asked to provide tumour samples. The exact number of visits and the total length of your participation will depend on which part of the study you are in and how you respond to the treatment, but it will involve ongoing assessments and follow-up.

Potential risks and benefits

Participating in a study like this might offer a potential benefit by giving you access to a new treatment that isn't widely available yet, which could help your cancer. However, it's important to remember that this is a new medicine, so there might be side effects or risks that we don't fully know about yet. There is no guarantee that the treatment will help your specific cancer. You will be closely monitored for any side effects, and the study team will discuss potential risks with you in detail. You are free to withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (8)

Rigshospitalet
Verified postcode
Copenhagen, Denmark
Universitätsklinikum Essen
Verified postcode
Essen, Germany
Hospital HM Nou Delfos
Verified postcode
Barcelona, Spain
HM Sanchinarro
Verified postcode
Madrid, Spain
Hospital Fundacion Jimenez Diaz
Verified postcode
Madrid, Spain
Hospital universitario Virgen del Rocio
Verified postcode
Seville, Spain
Lund University Hospital
Verified postcode
Lund, Sweden
Karolinska University Hospital, Solna
Verified postcode
Stockholm, Sweden

Common questions

What is BI-1910?

BI-1910 is a new experimental medicine being tested for cancer treatment. Its exact benefits and risks are still being studied.

What kind of cancers is this study for?

This study is for people with advanced solid tumours, which are cancers that have grown or spread. This includes specific types like non-small cell lung cancer and hepatocellular carcinoma (liver cancer).

What does 'advanced solid tumours' mean?

It means the cancer has either grown locally into surrounding tissues or has spread to other parts of the body (metastatic disease).

Will I get BI-1910 by itself or with pembrolizumab?

The study is designed to test BI-1910 both alone and in combination with pembrolizumab. Which treatment you receive will be decided by the study design and your specific situation.

How long will I be in the study?

The length of time you'll be in the study depends on your response to treatment and which part of the study you're in. The study team will provide more details.