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RecruitingPHASE1INTERVENTIONAL

Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors

This research study is looking into a new treatment called lunresertib. It's being tested alone, and also combined with two other medicines (RP-3500 or Debio 0123), for people who have advanced solid tumours that have grown or returned. The main goals are to check how safe these treatments are and what side effects they might cause. Researchers also want to find the highest dose that can be given safely and see if the treatments help to control or shrink the tumours. This is an early-stage study, meaning it's one of the first times these medicines are being tested in people.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Debiopharm International SA
Enrolment target
464
Start
30 Apr 2021
Estimated completion
01 Jun 2028

What is this study about?

This study is a Phase 1 clinical trial, which means it's an early step in testing a new medicine. Researchers are looking at a treatment called lunresertib, sometimes on its own and sometimes with other medicines known as RP-3500 or Debio 0123. The main reason for this study is to find out if these medicines are safe for people with advanced solid tumours, which are cancers that have spread or are difficult to treat.

They will be carefully watching for any side effects and trying to work out the best dose of lunresertib, both by itself and when given with the other two medicines. This involves gradually increasing the dose to find the highest amount that can be given without causing too many problems. The researchers will also be checking how the medicines move through the body and how they affect the cancer cells. This helps them understand how the treatment works.

Ultimately, a key part of this study is to see if these new treatments can help to stop the cancer from growing or even shrink the tumours. This research is important because it could lead to new ways of treating advanced solid tumours in the future. The study started under one sponsor and is now being managed by Debiopharm International S.A.

Key takeaways

  • This is an early-stage study (Phase 1) for advanced solid tumours.
  • It tests a new medicine, lunresertib, alone or combined with others.
  • The main goals are to check safety, find the best dose, and look for tumour shrinkage.
  • Specific tumour markers are needed to join.
  • Participants must be at least 12 years old.
  • You can stop participating at any time.

Who may be eligible?

To be able to join this study, people need to be at least 12 years old. They must have solid tumours that are advanced, meaning they have spread or haven't responded well to previous treatments. For those under 18, there's also a minimum weight requirement of 40 kg. Participants will need to have good general health, including healthy blood and organ function.

Doctors will also check specific features of your tumour using tests like tissue samples or blood tests. These tests look for certain changes in the cancer cells (like 'CCNE1 amplification', 'FBXW7 deleterious mutations', or 'PPP2R1A deleterious mutations') that suggest the treatment might be more likely to work. You need to be able to swallow medicines by mouth. If you have been on other treatments, you’ll need to have recovered from any side effects before starting this study.

There are also some reasons why someone might not be able to join. These include being pregnant or breastfeeding, having received certain cancer treatments too recently, or any other health condition that might make participating unsafe or complicate the study results. Your study doctor will review all your health information carefully to see if this study is right 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.

  1. Are you 12 years old or older?
  2. Do you have a solid tumour that is advanced or hasn't responded well to treatment?
  3. Are you (or your child, if under 18) able to take medicines by mouth?
  4. Have your doctors identified specific markers in your tumour (like CCNE1, FBXW7, or PPP2R1A changes)?
  5. Have you recovered from side effects of any previous cancer treatments?
  6. Are you not pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the study medication (lunresertib, either alone or with RP-3500 or Debio 0123) to take by mouth. You will have regular visits to the clinic for check-ups, which will involve physical examinations, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects. You'll need to answer questions about your health and how you are feeling. The exact number of visits and the duration of your participation will depend on how you respond to the treatment and the study plan, but you should expect frequent appointments. Your health will continue to be monitored even after you stop taking the study medication.

Potential risks and benefits

Taking part in a study like this might have potential benefits, such as receiving a new treatment that isn't widely available yet, which could help control your cancer. However, it's also important to remember that this is an early-stage study, and the exact benefits are not yet known. Medicines can have side effects, and you might experience some from lunresertib or the combination treatments. These could range from mild to more serious, and the study team will monitor you closely. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (22)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • # 1019, UCLA, Westwood Cancer Center
    Verified postcode
    Los Angeles, United States· Completed
  • #1025, University of California San Francisco
    Verified postcode
    San Francisco, United States· Recruiting
  • #1012, Yale
    Verified postcode
    New Haven, United States· Recruiting
  • #1017, Mayo Clinic
    Verified postcode
    Jacksonville, United States· Recruiting
  • #1002, Dana Farber Cancer Institute
    Verified postcode
    Boston, United States· Recruiting
  • #1023, START Midwest
    Verified postcode
    Grand Rapids, United States· Recruiting
  • #1016, Mayo Clinic
    Verified postcode
    Rochester, United States· Recruiting
  • #1011, Washington University
    Verified postcode
    St Louis, United States· Recruiting
  • #1032, Northwell Health Cancer Institute
    Verified postcode
    New Hyde Park, United States· Recruiting
  • #1008, Columbia University
    Verified postcode
    New York, United States· Completed
  • #1004, Memorial Sloan Kettering Cancer Institute
    Verified postcode
    New York, United States· Recruiting
  • #1010, University of Pennsylvania
    Verified postcode
    Philadelphia, United States· Completed

Common questions

What kind of cancer is this study for?

This study is for people with advanced solid tumours, which means cancers that have spread or are hard to treat.

What are 'lunresertib', 'RP-3500', and 'Debio 0123'?

These are the names of the experimental medicines being tested in this study. They are not yet approved for general use.

What does 'Phase 1' mean?

Phase 1 means this is an early study. The main goals are to check if the new medicines are safe, find the right dose, and see how they are tolerated by the body.

Will I definitely get the new treatment?

Yes, everyone in this study will receive lunresertib, either on its own or in combination with RP-3500 or Debio 0123.

Can I leave the study if I want to?

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

How to find out more

Debiopharm International S.A

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 Lunresertib Alone or in Combination With RP-3500 or…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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