RecruitingPHASE1INTERVENTIONAL

A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation

This study is for adults with advanced solid cancers that have a specific genetic change called KRAS G12C. We're testing a new drug, BAY3498264, with an approved cancer drug called sotorasib. Sotorasib works by targeting cancer cells with this specific genetic change, but its effects often don't last forever. BAY3498264 aims to boost how well sotorasib works and for how long. Researchers want to understand how safe this combination is and find the best dose of BAY3498264 to give with sotorasib. Participants will receive BAY3498264 alone for a week, then both drugs together in cycles, aiming to find a better way to treat these cancers.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Bayer

Enrolment target

104

Start

08 Nov 2024

Estimated completion

31 May 2027

Advanced Solid Tumors Harboring KRAS G12C Mutation

What is this study about?

This research study is exploring a new way to treat advanced solid cancers that have a particular genetic change, known as a KRAS G12C mutation. If your cancer has this specific change, it means the cancer cells have a faulty protein that helps them grow. Researchers are always looking for better treatments to help people whose cancer has progressed after standard therapies.

You might already know about sotorasib, which is a medicine that specifically targets cancer cells with the KRAS G12C mutation. It's already approved and helps stop these cancer cells from growing. However, while sotorasib can work well, its effects can sometimes wear off after a while, and the cancer might start to grow again. That's why scientists are investigating new approaches.

This study introduces a new drug called BAY3498264. This drug is still in development, and it's thought to work by blocking another protein linked to KRAS. The idea is that by combining BAY3498264 with sotorasib, sotorasib might become even more effective. This could mean the treatment works for a longer time or has a stronger effect on the cancer. The main goal of this particular study is to first check how safe the new drug BAY3498264 is when given with sotorasib, and to find the highest dose that can be given safely to patients.

Key takeaways

This study is for adults with advanced solid cancers that have a KRAS G12C genetic change.
It's testing a new drug (BAY3498264) combined with an approved drug (sotorasib).
The main goals are to check the safety of this combination and find the best dose.
You'll have regular medical tests and scans to monitor your health.
Participation is voluntary, and you can leave the study at any time.
This is a 'first-in-human' study, so the new drug's effects aren't fully known yet.

Who may be eligible?

This study is looking for adults aged 18 or older who have advanced solid cancers that have been confirmed to have the KRAS G12C genetic change. To be considered, your cancer must have progressed after at least one standard treatment, and you should ideally have no other standard treatment options available, or feel that this study is a good option for you.

We need to check your general health, and your doctor will consider your overall well-being and how well you can carry out daily activities. You can't join the study if you have active brain tumours or certain ongoing neurological symptoms. If you've previously had treatment for brain tumours, you might still be able to join if they are stable and you meet specific conditions.

Quick self-check

Are you 18 years old or older?
Do you have an advanced solid cancer with a confirmed KRAS G12C genetic change?
Has your cancer progressed after at least one standard treatment?
Do you have no other standard treatment options or feel this study is a good choice for you?
Are you in generally good health, able to carry out most daily activities?
Do you not have active brain tumours or serious neurological symptoms?

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

What does participation involve?

If you decide to take part, you'll first receive the new drug BAY3498264 by itself for seven days. After this, you'll take BAY3498264 along with sotorasib. These combined treatments will be given in cycles, with each cycle lasting 21 days. You will take sotorasib every day at a standard, approved dose, alongside BAY3498264. The full duration of the treatment will continue for as long as it benefits you, without severe side effects, or until you or your doctor decide to stop, or if your cancer starts to grow again.

Throughout the study, the research team will closely monitor your health. This will involve regular blood and urine tests, body scans like CT, PET, MRI, and X-rays, and heart checks using an ECG machine. These checks help the doctors understand how the treatment is working and make sure it's safe for you.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, as you would be among the first to try a new combination treatment that could potentially work better or for longer than sotorasib alone. However, there are also potential risks; since BAY3498264 is a new drug, all its side effects aren't fully known, and the combination might cause unexpected reactions. Your health will be closely monitored, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (10)

Border Medical oncology - Albury Wodonga Regional Cancer Centre
Albury, Australia· Recruiting
Macquarie University Hospital - Oncology Department
Macquarie Park, Australia· Recruiting
Peninsula and Southeast Oncology
Frankston, Australia· Recruiting
Rigshospitalet - Kræftbehandling
Copenhagen, Denmark· Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
Rome, Italy· Recruiting
Gruppo Humanitas - Humanitas Research Hospital - Cancer Center
Rozzano, Italy· Recruiting
Institut Catala D'oncologia | Hospitalet | Oncologia
L'Hospitalet de Llobregat, Spain· Recruiting
Hospital Universitari Vall D Hebron | Oncologia
Barcelona, Spain· Not yet recruiting
The Christie NHS Foundation Trust - Christie Hospital
Manchester, United Kingdom· Recruiting
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton
Sutton, United Kingdom· Recruiting

Common questions

What is a 'KRAS G12C mutation'?

It's a specific change in your cancer cells' genes that helps them grow. This study focuses on cancers with this particular change.

Will I stop my current cancer treatment if I join?

This study is for people whose cancer has progressed after at least one prior treatment. Your doctor will discuss if it's the right step for you.

What is the difference between a 'Phase I' study and others?

Phase I studies are the first time a new drug or combination is tested in people. Their main goal is to check safety and find the right dose, rather than how well it works.

How long will I be in the study?

You'll continue treatment as long as it's helping you and you're not having severe side effects, or until you or your doctor decide to stop.

What if I experience side effects?

The research team will closely monitor your health for any side effects, and they will provide care and guidance if you experience any.

How to find out more

Bayer Clinical Trials Contact

clinical-trials-contact@bayer.com (+)1-888-84 22937 Official trial record

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