RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

This study is looking at a new treatment called BI-1206, given alongside an existing cancer medicine, pembrolizumab, for adults with advanced solid tumours. It’s for people whose cancer has either advanced despite previous immune-based treatments (for the first part of the study) or who haven't had prior systemic treatment for their advanced non-small cell lung cancer or uveal melanoma (for the second part). The study has two main phases. The first phase is finding the safest and most effective dose of BI-1206. The second phase will then test this dose in specific types of cancer, like non-small cell lung cancer and uveal melanoma. The goal is to see if this new combination can help control the cancer and improve how people respond to treatment.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

BioInvent International AB

Enrolment target

197

Start

29 Jun 2020

Estimated completion

01 Nov 2027

Solid Tumor, Adult

What is this study about?

This research study is about exploring a new treatment for advanced solid tumours – these are cancers that grow as a solid mass and have spread or are difficult to treat. The treatment involves a new medicine called BI-1206, which will be given alongside an existing cancer drug called pembrolizumab, already used to help the body's immune system fight cancer. We want to find out the best and safest dose of BI-1206 when used with pembrolizumab, and then see how well this combination works against certain types of advanced cancer.

The study is divided into two main parts. The first part focuses on finding the right dose of BI-1206, testing different amounts given either into a vein (intravenously) or under the skin (subcutaneously). This helps scientists understand how the body handles the drug and what dose is both safe and effective. Once the best dose is found, the second part of the study begins. Here, patients with specific advanced cancers – like non-small cell lung cancer or a type of eye cancer called uveal melanoma – will receive the combination treatment at the chosen dose.

Patients in this second part will receive pembrolizumab intravenously and BI-1206 under the skin. The aim is to carefully observe whether this combination can help control the cancer, shrink tumours, or stop them from growing for a longer time. The study will look closely at how patients respond and if they experience any side effects. Ultimately, the hope is that this new combination could offer a helpful treatment option for people living with these advanced cancers.

Key takeaways

This study is testing a new drug (BI-1206) with an existing cancer treatment (pembrolizumab).
It's for adults with advanced solid tumours, specifically certain types of non-small cell lung cancer or uveal melanoma.
The initial aim was to find the safest and most effective dose of BI-1206.
The study now focuses on testing this combination in specific cancer types.
Patients are currently being recruited for the second part of the study (Phase 2a).
You will receive regular check-ups and treatment for several months, potentially longer, if the treatment is beneficial.

Who may be eligible?

This study is particularly looking for adults aged 18 or over. If you're interested, you'll need to be willing to sign a consent form to show you understand and agree to take part.

For the first part of the study (which is no longer enrolling new patients), participants needed to have a solid tumour that had continued to grow despite having already received at least two doses of an existing immune-boosting cancer treatment.

For the current part of the study (Phase 2a), we are looking for people with specific types of advanced cancer who have not had other treatments for their advanced disease. This includes those with advanced non-small cell lung cancer where certain genetic changes (EGFR or ALK) are not present, or with advanced uveal melanoma. For both of these cancers, your tumour also needs to show a certain level of a marker called PD-L1. You'll need to provide a recent tumour tissue sample for testing as well.

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 advanced non-small cell lung cancer (without specific genetic changes like EGFR or ALK, and with high PD-L1 levels)?
OR do you have advanced uveal melanoma (with PD-L1 present)?
Have you NOT received other body-wide immunotherapy or chemotherapy for your advanced cancer?
Are you able to provide a recent tumour tissue sample?
Are you willing and able to give your informed consent to participate?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first receive the combination treatment of pembrolizumab and BI-1206 for a set period of about 9 weeks (3 cycles). Depending on which part of the study you are in, BI-1206 might be given into your vein or as an injection under your skin, while pembrolizumab is given into your vein.

Your doctors will regularly check your health to see how the treatment is affecting you and your cancer. If your cancer shows signs of improving or remaining stable after 9 weeks, you may be able to continue receiving the combination treatment. This could last for up to 32 more cycles, or up to two years from your first dose of BI-1206, or until your cancer starts to progress again, whichever comes first.

Taking part will involve regular visits to the hospital for your treatments, blood tests, scans, and check-ups to monitor your progress and any side effects. The exact number of visits will depend on how long you stay on the treatment.

Potential risks and benefits

Participating in a study like this might offer a potential benefit of trying a new treatment combination that could help control your cancer. However, there's no guarantee it will work for everyone, and it's also possible you may not experience any improvement. As with any medication, there are potential risks of side effects. Your study team will explain these in detail so you can make an informed decision. You are always in control and can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (25)

University of California Los Angeles
Verified postcode
Los Angeles, United States· Not yet recruiting
Sarah Cannon Research Institute
Verified postcode
Denver, United States· Completed
HealthPartners Institute - Regions Cancer Care Center,
Verified postcode
Saint Paul, United States· Completed
Oklahoma University , Stephenson Cancer Center
Verified postcode
Oklahoma City, United States· Completed
NEXT Oncology
Verified postcode
San Antonio, United States· Completed
LTD High Technology Hospital Med Center
Verified postcode
Batumi, Georgia· Recruiting
Israel-Georgian Medical Research Clinic Helsicore
Verified postcode
Tbilisi, Georgia· Terminated
Jerarsi Clinic
Verified postcode
Tbilisi, Georgia· Recruiting
Medizinische Hochschule Hannover
Verified postcode
Hanover, Germany· Not yet recruiting
Nationales Centrum für Tumorerkrankungen
Verified postcode
Heidelberg, Germany· Not yet recruiting
Universität des Saarlandes
Verified postcode
Homburg, Germany· Not yet recruiting
Maria Skłodowska-Curie National Institute of Oncology
Verified postcode
Gliwice, Poland· Terminated

Common questions

What is a 'solid tumour'?

A solid tumour is a type of cancer that forms a distinct mass of tissue, unlike blood cancers. Examples include lung cancer, breast cancer, or bowel cancer.

What is 'advanced' cancer?

Advanced cancer means the cancer has spread to other parts of the body or has come back after treatment. It can also refer to cancer that is difficult to treat with standard methods.

What do 'intravenous' and 'subcutaneous' mean?

'Intravenous' means the medicine is given directly into a vein, usually in your arm. 'Subcutaneous' means the medicine is injected under your skin, often in your stomach or thigh.

What is 'pembrolizumab'?

Pembrolizumab is a type of immunotherapy that helps your body's own immune system find and fight cancer cells. It's an approved treatment for several cancers.

Can I join this study if I've already had lots of cancer treatments?

For the part of the study currently open, you generally should *not* have received previous systemic (body-wide) immunotherapy or chemotherapy for your advanced non-small cell lung cancer or uveal melanoma. However, it's always best to discuss your full medical history with the study team.

How to find out more

Philipp Zimmermann, Dr. rer. nat.

philipp.zimmermann@bioinvent.com +46735504521 Official trial record

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