Active not recruitingPHASE3INTERVENTIONAL

Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)

The KRYSTAL-10 study is a Phase 3 clinical trial investigating a new treatment approach for advanced bowel (colorectal) cancer. It focuses on individuals whose cancer has a particular genetic mutation called KRAS G12C. This study aims to find out if combining two drugs, MRTX849 and cetuximab, is more effective than standard chemotherapy for patients who have already received their first round of treatment and whose cancer has progressed. Participants will be randomly assigned to receive either the new drug combination or chemotherapy. This research is designed to help improve future treatment options for this specific type of advanced bowel cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Mirati Therapeutics Inc.

Enrolment target

461

Start

19 Jul 2021

Estimated completion

31 Jul 2026

Advanced Colorectal Cancer Metastatic Colorectal Cancer

What is this study about?

This study, called KRYSTAL-10, is looking into a new treatment for advanced bowel cancer. Bowel cancer is a type of cancer that starts in the large bowel. 'Advanced' means the cancer has spread beyond where it started. Researchers are particularly interested in patients whose cancer has a specific change (mutation) in something called the KRAS gene, specifically the G12C type. This change can make the cancer behave differently and respond to certain treatments.

The main goal of KRYSTAL-10 is to see if a combination of two medicines, called MRTX849 and cetuximab, works better than the standard chemotherapy treatments currently used. Chemotherapy involves powerful drugs that kill fast-growing cancer cells. MRTX849 is a newer drug designed to specifically target the KRAS G12C mutation, while cetuximab is another type of drug that works by blocking signals that help cancer cells grow.

This is a 'Phase 3' study, which means it’s a later stage of research involving more people, aiming to confirm if the new treatment is safe and effective compared to existing options. If successful, this new combination could provide a valuable treatment choice for people with this specific type of advanced bowel cancer.

Key takeaways

This study is for advanced bowel cancer with a specific genetic change (KRAS G12C).
It compares a new drug combination against standard chemotherapy.
Participants must have already received one round of chemotherapy for their advanced cancer.
This is a Phase 3 study, aiming to confirm treatment effectiveness.
The goal is to improve future treatment options for this type of bowel cancer.

Who may be eligible?

To join this study, people need to have been diagnosed with bowel cancer that has spread, and a special test of their tumour must show a specific genetic change called KRAS G12C. Importantly, they must have already received one round of chemotherapy for their advanced bowel cancer, which included drugs like oxaliplatin or irinotecan, and their cancer must have shown signs of growing again after that treatment. Participants should be 18 years old or older.

There are also some reasons why people would not be able to join. For example, if they have already received a treatment specifically designed to target the KRAS G12C mutation (like a drug called AMG 510) or if they have previously had a treatment targeting the 'EGFR' protein (like cetuximab or panitumumab). Anyone with active cancer that has spread to the brain (brain metastases) would also not be able to take part.

Quick self-check

Do you have advanced bowel cancer that has spread?
Has your tumour been tested and shown to have a KRAS G12C mutation?
Have you already had one course of chemotherapy for your advanced bowel cancer?
Has your cancer shown signs of growing again after that first chemotherapy?
Are you 18 years old or older?
Have you NOT had previous treatment for the KRAS G12C mutation or certain anti-EGFR drugs?

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 would be randomly assigned to one of two treatment groups: either the new drug combination (MRTX849 and cetuximab) or a standard chemotherapy regimen (mFOLFOX6 or FOLFIRI). This is an 'open-label' study, meaning both you and your doctors will know which treatment you are receiving. You will have regular hospital visits for treatment, tests, and check-ups to monitor your health and how the treatment is working. This will involve blood tests, scans, and physical examinations. The total duration of your participation will depend on how you respond to the treatment, but typically continues as long as the treatment is beneficial and you are tolerating it well. After stopping the study treatment, there will be follow-up appointments to track your long-term health.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new treatments before they are widely available and close medical monitoring. While the new treatments are being tested to see if they are more effective than current ones, there's no guarantee they will work for everyone, or that they will be better than standard treatment. As with all medicines, there are potential side effects, and these will be thoroughly explained by the study team. Some side effects can be mild, while others might be more serious. You will be monitored closely for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (419)

Local Institution - 010-855-E
Alabaster, United States
Local Institution - 010-855-B
Bessemer, United States
Local Institution - 010-855-D
Birmingham, United States
Local Institution - 010-855-A
Birmingham, United States
Local Institution - 010-855-F
Birmingham, United States
Local Institution - 010-855-C
Birmingham, United States
Local Institution - 010-855
Birmingham, United States
Local Institution - 010-996
Gilbert, United States
Local Institution - 010-566
Goodyear, United States
Local Institution - 010-989
Phoenix, United States
Local Institution - 010-978
Springdale, United States
Local Institution - 010-573
Bakersfield, United States

+407 more sites — see the official record for the full list.

Common questions

What is 'advanced colorectal cancer'?

It means bowel cancer that has spread beyond its original location to other parts of the body.

What is the KRAS G12C mutation?

It's a specific genetic change found in some cancer cells that can influence how the cancer grows and responds to treatment.

What does 'randomized' mean in a study?

It means participants are put into different treatment groups by chance, like flipping a coin, to ensure a fair comparison.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, so you and your doctor will know which treatment you are receiving.

Can I stop participating in the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, without affecting your medical care.