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RecruitingPHASE1INTERVENTIONAL

Actinium Therapy for Late-stage Aggressive Sarcomas

This research study is looking into a new treatment, RTX-2358, for adults with advanced soft tissue sarcoma. This is a type of cancer that affects the body's soft tissues. The study aims to find out if the new drug is safe to use and what the best dose might be. Researchers also want to see if it helps to treat the cancer. They will also be testing an imaging agent, LNTH-1363S, which helps doctors see what's happening inside the body. This is an early-stage study, meaning it's one of the first times this treatment is being tested in people.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Ratio Therapeutics, Inc.
Enrolment target
30
Start
12 Nov 2025
Estimated completion
01 Jan 2032

What is this study about?

This study is a clinical trial, which means it's a way for doctors and scientists to test new treatments to see if they are safe and effective. This particular study is for people who have advanced soft tissue sarcoma. This is a type of cancer that can develop in different parts of your body, like muscles, fat, blood vessels, or other connective tissues. "Advanced" means the cancer has spread or is difficult to treat with standard methods.

The main goals of this study are to learn more about a new drug called RTX-2358. Doctors want to know if it's safe for people to take, what side effects it might cause, and what the best amount (dose) to give is. They also want to see if it helps to shrink or control the cancer. Another part of the study involves an imaging agent called LNTH-1363S, which helps doctors get clearer pictures of the cancer and how the treatment is working.

Early studies like this are very important because they help researchers understand if a new treatment has the potential to help people in the future. If this drug proves to be safe and shows promising signs of working, it could eventually lead to a new treatment option for people living with soft tissue sarcoma. The study is divided into two main parts. The first part, which is described here, involves giving different groups of patients slightly different doses to find the safest and most effective amount.

Key takeaways

  • This study tests a new drug (RTX-2358) for advanced soft tissue sarcoma.
  • It's an early-stage study to check safety, best dose, and potential effectiveness.
  • Participants receive treatment injections every 8 weeks for up to a year.
  • Regular clinic visits and long-term follow-up are part of participating.
  • This trial is for adults whose soft tissue sarcoma has returned or hasn't responded to other treatments.
  • You can stop participating at any time.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have soft tissue sarcoma that has either come back after treatment or hasn't responded well to previous treatments. Your cancer must be visible on scans, and a special type of PET scan needs to show that it is active in a certain way.

You also need to be in generally good health, meaning your blood tests and organ functions (like your kidneys and liver) need to be working well. If you are a man or woman who could have children, you must agree to use two reliable forms of birth control during the study and for some time afterward.

There are also some reasons why you might not be able to join. For example, if you've had certain types of radiation therapy, another type of similar treatment recently, or major surgery within the last two weeks. Certain heart conditions or other serious uncontrolled health issues might also prevent you from taking part.

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. Have you been diagnosed with soft tissue sarcoma that has come back or hasn't responded to previous treatments?
  3. Is your cancer visible on medical scans?
  4. Are your general health and organ functions (like kidneys, liver) in good condition?
  5. Are you able to use two forms of birth control if you could become pregnant or make someone pregnant?
  6. Have you not had certain types of radiation or major surgery recently (within the last 2 weeks)?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study drug, RTX-2358, as an injection once every eight weeks. You might have up to six injections, with a target of four, over about a year, depending on how your body reacts and how your cancer responds.

During the first treatment cycle, you'll visit the clinic three times in the first week, and then once a week for the remaining seven weeks of that cycle for check-ups and tests. For cycles two to six, you will visit the clinic once every two weeks for your appointments and follow-up tests. After your treatment period, you will have long-term follow-up visits, either in person or remotely, every six months for up to five years, to keep track of your health and the cancer.

Potential risks and benefits

Taking part in any clinical trial comes with potential benefits and risks. The potential benefit of this study is that you might be among the first to receive a new treatment that could help your advanced soft tissue sarcoma, especially if other treatments haven't worked. However, there's no guarantee that the treatment will be effective for you. There are always potential risks, including side effects from the new drug, which doctors will closely monitor. You will receive detailed information about these possible side effects. Remember, joining this study is completely your choice, and you are free to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (6)

  • UCLA
    Verified postcode
    Los Angeles, United States· Recruiting
  • Mayo Clinic
    Verified postcode
    Rochester, United States· Recruiting
  • Memorial Sloane Kettering Cancer Center
    Verified postcode
    New York, United States· Recruiting
  • Case Western
    Verified postcode
    Cleveland, United States· Recruiting
  • MD Anderson Cancer Center
    Verified postcode
    Houston, United States· Recruiting
  • Princess Margaret Cancer Centre
    Verified postcode
    Toronto, Canada· Not yet recruiting

Common questions

What is soft tissue sarcoma?

Soft tissue sarcoma is a rare type of cancer that develops in the body's soft tissues, like muscles, fat, blood vessels, nerves, and tendons.

What does 'advanced' cancer mean?

Advanced cancer means the cancer has grown or spread from where it started, or it hasn't responded to previous treatments.

Is this a new drug?

Yes, RTX-2358 is a new drug being tested in people for the first time in this study to see if it's safe and effective.

How long will I be in the study?

You will receive treatment for up to about a year, and then you'll have follow-up appointments for up to five years to monitor your health.

Will I know if I'm getting the active drug?

Yes, in this study, everyone will receive the active study drug RTX-2358. There isn't a placebo (dummy treatment) group.

How to find out more

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 "Actinium Therapy for Late-stage Aggressive Sarcomas…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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