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RecruitingPHASE3INTERVENTIONAL

Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

This study is looking for adults with a specific type of cancer called gastroenteropancreatic neuroendocrine tumours (GEP-NETs). This is for people whose cancer has spread and can't be removed by surgery, and where their previous treatment with Lutetium-177 has stopped working. The study is comparing a new medication called RYZ101 with existing standard treatments like Everolimus, Sunitinib, Octreotide, or Lanreotide. We want to find out if RYZ101 is safe, how it works in the body, and how effective it is at controlling the cancer compared to the standard options. The study aims to improve treatments for this type of cancer.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
RayzeBio, Inc.
Enrolment target
338
Start
24 Mar 2022
Estimated completion
01 Dec 2030

What is this study about?

This research study is about a type of cancer called gastroenteropancreatic neuroendocrine tumours, often shortened to GEP-NETs. These cancers start in special cells found in your gut or pancreas. For some people, these cancers can grow or spread and can't be removed by surgery. When this happens, doctors use treatments that help control the cancer, but these treatments don't always stop the cancer from growing for good.

This study is looking for people whose GEP-NETs have continued to grow even after they've had a specific type of treatment called Lutetium-177. We are testing a new medicine called RYZ101. The main goal is to see if RYZ101 can be a safe and effective new option for these patients. We will compare it to common treatments that doctors already use, such as Everolimus, Sunitinib, Octreotide, or Lanreotide, to see if RYZ101 works better at controlling the cancer's growth and spread.

The study has two parts. The first part helps us understand the best dose of RYZ101 and how it moves through the body. The second and main part of the study will seriously compare this new medicine with standard treatments to understand its safety and how well it works. This research is important because it could lead to new and better ways to treat GEP-NETs for people who have limited options.

Key takeaways

  • This study is for adults with a specific type of GEP-NET cancer.
  • Your cancer must have progressed after previous Lutetium-177 treatment.
  • The study compares a new medicine (RYZ101) with standard treatments.
  • It aims to find out if RYZ101 is safe and more effective.
  • Participation involves regular hospital visits, tests, and medical monitoring.

Who may be eligible?

To be considered for this study, you would need to have specific type of GEP-NET cancer that has been confirmed by a doctor. Your cancer must be well-differentiated (meaning the cells still look a bit like normal cells) and growing, and can't be removed by surgery. Importantly, your cancer must have grown even after you've already had Lutetium-177 treatment, and it should show up on a special type of scan called an SSTR-PET scan.

You also need to be generally well enough to take part, meaning you can mostly look after yourself. Your kidneys, blood, and liver need to be working properly, which will be checked with blood tests. There are some conditions that would mean you couldn't join. For example, if you've already had certain types of radiation treatment called radioembolisation or if you have serious heart problems like severe heart failure or very high blood pressure that can't be controlled with medicines. Also, if your diabetes is not well managed, you might not be able to participate.

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. Have you been diagnosed with an inoperable GEP-NET cancer?
  2. Has your GEP-NET cancer grown after Lutetium-177 (Lu-177) treatment?
  3. Do you feel generally well enough for a study, with good organ function?
  4. Do you have any serious heart conditions or very high blood pressure?
  5. Is your diabetes well controlled (if you have diabetes)?
Answer every question to see your result.

What does participation involve?

If you join this study, it will involve regular hospital visits, where you'll have check-ups, blood tests, and scans (like SSTR-PET scans) to monitor your health and how your cancer is responding. Some visits might be more frequent at the beginning. You will receive either the new medicine RYZ101 or one of the standard treatments (Everolimus, Sunitinib, Octreotide, or Lanreotide). You won't get to choose which treatment you receive; this is decided randomly, like flipping a coin. You will continue treatment for as long as it is benefiting you and you are tolerating it well. After your treatment ends, there will be follow-up calls or visits to see how you are doing. The total time you're involved in the study can vary, depending on how you respond to the treatment, but it will involve ongoing monitoring.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. You might benefit from the new treatment RYZ101, which could potentially work better or have different side effects than existing options. However, there's no guarantee the treatment will work for you, and it's also possible you could receive a standard treatment. Like all medications, both RYZ101 and the standard treatments can cause side effects. The study team will carefully monitor you for these. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (54)

  • Research Facility
    Verified postcode
    Phoenix, United States· Active not recruiting
  • Research Facility
    Verified postcode
    Duarte, United States· Completed
  • Research Facility
    Verified postcode
    Irvine, United States· Recruiting
  • Research Facility
    Verified postcode
    Los Angeles, United States· Active not recruiting
  • Research Facility
    Verified postcode
    Palo Alto, United States· Active not recruiting
  • Research Facility
    Verified postcode
    San Francisco, United States· Active not recruiting
  • Research Facility
    Verified postcode
    New Haven, United States· Active not recruiting
  • Research Facility
    Verified postcode
    Washington D.C., United States· Active not recruiting
  • Research Facility
    Verified postcode
    Jacksonville, United States· Active not recruiting
  • Research Facility
    Verified postcode
    Miami, United States· Recruiting
  • Research Facility
    Verified postcode
    Tampa, United States· Recruiting
  • Research Facility
    Verified postcode
    Atlanta, United States· Active not recruiting

Common questions

What are GEP-NETs?

GEP-NETs are a type of cancer that starts in certain hormone-producing cells found in your gut (gastrointestinal tract) or pancreas.

What does 'inoperable' mean?

It means the cancer cannot be completely removed by surgery, often because it has spread or is in a difficult location.

What is Lutetium-177 treatment?

This is a type of radiation treatment where a radioactive substance is targeted directly to your cancer cells to help stop their growth.

Will I definitely get the new drug RYZ101?

No, you will be randomly assigned to receive either RYZ101 or one of the standard treatments that are already used for this type of cancer.

What is the aim of this study?

The study aims to see if the new medicine RYZ101 is safe and works better than current treatments for people with GEP-NETs whose cancer has progressed after Lutetium-177 treatment.

How to find out more

RayzeBio Clinical Trials

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 RYZ101 Compared With SOC in Pts w Inoperable SSTR+ …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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