Active not recruitingPHASE1INTERVENTIONAL

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

This research study, called CodeBreak 101, is for adults with advanced cancers that have a particular genetic change known as KRAS p.G12C. This genetic change can make cancer grow. The main goal is to find out how safe and well-tolerated a new drug, sotorasib, is when given alone or with other cancer treatments. Researchers will be carefully checking for any side effects and how patients react to the different drug combinations. The study hopes to find better ways to treat these types of cancers, ultimately aiming to improve the health and well-being of those affected. If you have been diagnosed with an advanced solid tumour and this specific genetic change, your doctor might discuss this trial with you.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Amgen

Enrolment target

610

Start

17 Dec 2019

Estimated completion

05 Dec 2027

Advanced Solid Tumors Kirsten Rat Sarcoma (KRAS) pG12C Mutation

What is this study about?

This study, known as CodeBreak 101, is exploring new treatment options for people with advanced solid cancers. 'Advanced' means the cancer has grown or spread, and 'solid' refers to cancers that form a lump or mass, rather than blood cancers like leukaemia.

The focus of this research is on a specific genetic change within the cancer cells called KRAS p.G12C. This particular change is like a switch that tells cancer cells to grow, and it's found in several types of cancer. Scientists have developed new drugs to specifically target this genetic change, aiming to stop the cancer from growing. This study is testing one such drug, named sotorasib, sometimes on its own and sometimes combined with other established cancer treatments.

The main purpose of this early-stage study (Phase 1) is to carefully check the safety of sotorasib, both alone and in different combinations. This involves looking at any side effects participants experience and how their bodies react to the treatment. By understanding the safety and early effects of these new approaches, researchers hope to pave the way for more effective treatments for people with KRAS p.G12C mutated cancers in the future.

Key takeaways

It's a study for advanced solid cancers with a specific KRAS p.G12C genetic change.
It's testing a new drug called sotorasib, sometimes with other treatments.
The main goal is to check the safety and tolerability of these treatments.
Participation requires you to be at least 18 years old.
Regular clinic visits, tests, and monitoring are part of the study.

Who may be eligible?

To be able to join this study, you must be at least 18 years old. You need to have a type of advanced cancer that has been identified by doctors as having a specific genetic change called KRAS p.G12C. This genetic change must have been found through a special test.

There are also some reasons why you might not be able to join. For example, if your cancer started in your brain, or if you have certain serious issues with your brain or spine due to cancer that aren't being treated. Also, if you've had a heart attack in the last six months, or if you have a stomach or bowel condition that makes it hard to take medicines by mouth, you wouldn't be able to participate. The study doctors will review your medical history carefully to see if it's suitable for you.

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 a type of advanced solid cancer?
Has your cancer been found to have the KRAS p.G12C genetic change?
Do you currently have a primary brain tumour, or active untreated brain metastases?
Have you had a heart attack in the last 6 months?
Are you able to take medicines by mouth?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive treatment with sotorasib, possibly alongside other medications, as decided by the study doctors. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. These visits might be frequent initially and then become less often over time. You will also need to report any side effects you experience to the study team. The total time you spend in the study will depend on how you respond to the treatment and the study plan, but it will involve ongoing follow-up with the medical team for a period of time.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit from receiving a new treatment that isn't yet widely available, and it could be effective for your cancer. However, there's no guarantee the treatment will work for you, and like all medicines, sotorasib and the other drugs can cause side effects. These side effects can range from mild to serious. The study team will explain all known potential risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (90)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Arizona Oncology Associates Professional Corporation
Verified postcode
Tucson, United States
City of Hope National Medical Center
Verified postcode
Duarte, United States
University of California San Diego Moores Cancer Center
Verified postcode
La Jolla, United States
Loma Linda University Cancer Center
Verified postcode
Loma Linda, United States
University of Southern California, Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States
University of California Davis Medical Center
Verified postcode
Sacramento, United States
University of California San Francisco Mission Bay Campus
Verified postcode
San Francisco, United States
University of California Los Angeles
Verified postcode
Santa Monica, United States
Rocky Mountain Cancer Centers Denver Midtown
Verified postcode
Denver, United States
Sarah Cannon Research Institute
Verified postcode
Denver, United States
Yale New Haven Hospital
Verified postcode
New Haven, United States
Norwalk Hospital
Verified postcode
Norwalk, United States

Common questions

What does 'advanced solid tumours' mean?

This means your cancer is a solid growth (not a blood cancer) and has grown or spread beyond its original location.

What is the KRAS p.G12C mutation?

It's a specific genetic change found in some cancer cells that can make the cancer grow. This study is testing drugs designed to target this change.

What is sotorasib?

Sotorasib is a new experimental drug developed to specifically block the effects of the KRAS p.G12C mutation, aiming to stop cancer growth.

Will I get sotorasib, or a different drug?

This study is testing sotorasib, sometimes on its own and sometimes with other cancer drugs. Your study doctor will explain which treatment plan you would be on.

What phase is this study?

This is a Phase 1 study, which means it's an early stage of clinical research primarily focused on checking the safety and best dose of the new treatment.