Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Brightline-2: A Phase IIa/IIb, open-label, single-arm, multi-centre trial of BI 907828 for treatment of patients with locally advanced / metastatic, MDM2 amplified, TP53 wild-type biliary tract adenocarcinoma, pancreatic ductal adenocarcinoma, or other selected solid tumours

This clinical trial, called Brightline-2, is looking at a new drug, BI 907828, to treat advanced cancers like certain pancreatic, lung, and bile duct cancers, as well as some bladder cancers. The study focuses on cancers that have a particular genetic change called MDM2 amplification and are TP53 wild-type. Researchers want to find out how effective the drug is at shrinking tumours (called 'objective response') and if it's safe for patients. This is a Phase II study, meaning it's exploring whether the drug works and checking for side effects. Participants will receive the study drug, and doctors will carefully monitor their progress. The aim is to help find better treatments for these types of cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim RCV GmbH & Co. KG

Enrolment target

Start

30 Oct 2023

Pancreatic ductal adenocarcinoma Lung adenocarcinoma Biliary tract adenocarcinoma Urothelial bladder cancer

What is this study about?

This study, known as Brightline-2, is testing a new medication called BI 907828. It's designed for people with certain advanced cancers that have specific genetic features. These cancers include some types of pancreatic (pancreatic ductal adenocarcinoma), lung (lung adenocarcinoma), bile duct (biliary tract adenocarcinoma), and bladder (urothelial bladder cancer) cancers. The 'advanced' part means the cancer has spread or can't be removed by surgery.

The key thing about the cancers in this study is that they must have two specific genetic characteristics: something called 'MDM2 amplified' and 'TP53 wild-type.' These are changes in the cancer cells that scientists believe the new drug might be able to target. By focusing on these specific genetic changes, researchers hope to find a treatment that works well for these particular types of cancer.

This is a Phase II study, which means the main goal is to see how well the drug works – specifically, if it can shrink tumours – and to check for any side effects. Doctors will be carefully measuring these things. The hope is to gather important information that could lead to new and better treatment options for people living with these challenging cancers.

Key takeaways

Tests a new drug for specific advanced cancers.
Focuses on cancers with particular genetic changes.
Main goal: see if the drug shrinks tumours and is safe.
Includes adults with certain pancreatic, lung, bile duct, or bladder cancers.
Important for finding new treatment options.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. The study includes both men and women.

The most important criteria relate to your cancer. You must have a diagnosis of locally advanced (meaning it hasn't spread widely but can't be removed by surgery) or metastatic (meaning it has spread to other parts of the body) cancer. This includes specific types such as pancreatic ductal adenocarcinoma, lung adenocarcinoma, biliary tract adenocarcinoma, or urothelial bladder cancer.

Crucially, your cancer cells must show two specific genetic features: they must be 'MDM2 amplified' and 'TP53 wild-type.' Your doctor will be able to arrange tests to confirm if your cancer has these specific genetic changes.

Quick self-check

Are you 18 years old or older?
Do you have advanced pancreatic, lung, bile duct, or bladder cancer?
Has your doctor confirmed your cancer has the 'MDM2 amplified' and 'TP53 wild-type' genetic features?
Are you willing to have regular hospital visits for treatment and check-ups?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will receive the new drug, BI 907828. This involves regular hospital visits for treatment and check-ups. Doctors will closely monitor your health throughout the study. This will include blood tests, scans (like CT or MRI scans), and physical examinations to see how you're responding to the treatment and to check for any side effects. You'll also be asked to fill out questionnaires about how you're feeling and your quality of life. The study will continue as long as the treatment is helping you and you are tolerating it well. After you stop taking the study drug, there will be some follow-up visits or calls to keep track of your health. The total duration of your participation will vary depending on your individual response to the treatment.

Potential risks and benefits

Taking part in a clinical trial might offer you access to a new drug that isn't yet widely available, which could potentially help your cancer. However, the drug is still being researched, so we don't know for sure how effective it will be or if it will work for everyone. There's also a chance you could experience side effects, some of which might be unpleasant or even serious. The research team will explain all known risks and closely monitor you for any problems. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

—
Spain
—
France
—
Belgium
—
Germany
—
Austria

Common questions

What is a 'Phase II' clinical trial?

A Phase II trial is when doctors are testing a new drug to see if it works and to check for side effects in a larger group of people. It helps determine if the drug is promising enough for bigger studies.

What does 'MDM2 amplified' and 'TP53 wild-type' mean?

These are specific genetic changes found in some cancer cells. The study drug is designed to target cancers that have these particular features.

What kind of cancers are being studied?

This study is for certain advanced pancreatic, lung, bile duct, and bladder cancers that have specific genetic changes.

What does 'objective response' mean?

Objective response means that doctors can measure that your tumour has shrunk or completely disappeared in response to the treatment.

Will I get 'better' if I join this trial?

While the aim is to find effective treatments, there's no guarantee the drug will work for everyone, or that it will make you 'better' in the sense of curing your cancer. It's about finding out if the drug can help control the cancer.