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RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors

This research study is investigating two new medications, Elironrasib and Daraxonrasib, for patients with advanced solid cancers, such as certain types of lung, bowel, and pancreatic cancer, that have a specific genetic change known as KRAS G12C. Our main goals are to understand if these drugs are safe, how your body handles them, and whether they can help shrink tumours. We're testing them on their own and also in combination. This study is taking place in different medical centres and involves a few stages, starting with finding the best dose and then seeing how effective it is. We hope to learn more about these potential new treatments to help people living with these cancers.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Revolution Medicines, Inc.
Enrolment target
534
Start
14 Nov 2023
Estimated completion
01 Jun 2029

What is this study about?

This study is focused on a specific type of cancer that has a genetic change called KRAS G12C. This change can make cancer cells grow. Researchers are looking at two new medicines, Elironrasib and Daraxonrasib, that are designed to target this particular change.

The main aim is to understand if these medicines are safe for patients and how they behave in the body. We'll be testing them both individually and in combination. The study also wants to see if these medicines can help stop the cancer from growing or even shrink the tumours. This is an important step in finding new ways to treat these types of cancer, especially for people whose cancer hasn't responded to previous treatments.

This study has a few stages. Initially, we will give different doses to find the safest and most effective amount of the medicine. Once we find the best dose, we will then study more people to confirm the safety and look more closely at how well the medicines work against the cancer.

Key takeaways

  • This study tests two new medicines for advanced cancers with a specific genetic change (KRAS G12C).
  • It aims to check safety and how well the medicines work, alone and together.
  • It's for people whose cancer has already been treated.
  • The study involves regular check-ups, scans, and blood tests.
  • You have the option to leave the study at any time.

Who may be eligible?

This study is looking for adults aged 18 or over who have advanced cancers that have spread or can't be cured by standard treatments. Your cancer must also have a specific genetic change called KRAS G12C. This includes certain types of lung, bowel, or pancreatic cancer.

To join, your cancer must have been treated before. For some specific cancers like non-small cell lung cancer, you would need to have already tried certain common treatments like immunotherapy, chemotherapy, and other KRAS G12C drugs. However, for other solid cancers, you might be eligible even if you haven't tried a KRAS G12C drug before.

There are also some important health checks, like having good general health and normal organ function. You wouldn't be able to join if you have cancer that started in your brain, or if your cancer has spread to your brain and is causing active problems. Also, if you've had major surgery recently or have certain stomach or bowel conditions that might affect how the medicine is absorbed, you might not be suitable.

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.

  1. Are you 18 years old or older?
  2. Do you have an advanced solid cancer with the KRAS G12C genetic change?
  3. Has your cancer been treated before?
  4. Do you have good general health and organ function?
  5. Do you not have cancer that started in your brain or active brain tumours?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either one of the new medicines or a combination of both. You will have regular hospital visits for check-ups, blood tests, and scans to see how you're responding and to monitor any side effects. The study involves different stages, starting with safely finding the right dose, then continuing to assess the medicine's effects. Your medical team will explain the full schedule of appointments and tests. The total time you'd be in the study can vary depending on your response to the treatment, but you can choose to leave the study at any time.

Potential risks and benefits

Taking part in this study may offer a chance to receive new treatments that are not yet widely available. While these medicines might help control your cancer, there's no guarantee. There could also be side effects from the medicines, which your doctors will monitor closely. You will be given full information about potential risks. Remember, you have the right to leave the study at any point, for any reason, without it affecting your usual medical care.

Locations (53)

  • City of Hope
    Verified postcode
    Duarte, United States· Withdrawn
  • UC IRVINE Health
    Verified postcode
    Orange, United States· Recruiting
  • UC Davis Comprehensive Cancer Center
    Verified postcode
    Sacramento, United States· Recruiting
  • Stanford Cancer Institute
    Verified postcode
    Stanford, United States· Recruiting
  • University of Colorado Cancer Center
    Verified postcode
    Aurora, United States· Recruiting
  • Florida Cancer Specialists
    Verified postcode
    Sarasota, United States· Recruiting
  • Moffitt Cancer Center and Research Institute
    Verified postcode
    Tampa, United States· Recruiting
  • Dana Farber Cancer Institute
    Verified postcode
    Boston, United States· Recruiting
  • Henry Ford Cancer
    Verified postcode
    Detroit, United States· Withdrawn
  • START Midwest
    Verified postcode
    Grand Rapids, United States· Recruiting
  • Columbia University
    Verified postcode
    New York, United States· Recruiting
  • NYU Langone Health
    Verified postcode
    New York, United States· Recruiting

Common questions

What is KRAS G12C?

KRAS G12C is a specific genetic change found in some cancer cells that can make them grow and spread. These new medicines are designed to target this change.

Are these medicines approved for use?

No, these are new medicines being tested in a clinical trial. They are not yet approved for general use outside of this study.

Will I receive a placebo (dummy drug)?

No, in this study, all participants will receive either one or both of the active study medicines. There is no placebo group.

What types of cancer are being studied?

This study is for advanced solid cancers with the KRAS G12C genetic change, including certain types of non-small cell lung cancer, bowel cancer, and pancreatic cancer.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any time, for any reason. Your decision will not affect your ongoing medical care.

How to find out more

Revolution Medicines, Inc.

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

Interested in taking part?

Register your interest

Share your details and the research team for "Study of Elironrasib and Daraxonrasib as Monotherapies and C…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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