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RecruitingPHASE1INTERVENTIONAL

Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma

This research study is trying out a new medicine called XmAb®819 for people with advanced clear cell renal cell carcinoma (a type of kidney cancer). The cancer must have either come back or not responded to standard treatments. Doctors want to check how safe the medicine is and if it causes side effects. They also want to find the right amount, or dose, to give to patients. The medicine can be given through a drip (IV) or as an injection under the skin (SC). The study will also look at how the body handles the medicine and if it helps shrink the cancer. This is an early-stage study, meaning it's one of the first times this medicine is being tested in people.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Xencor, Inc.
Enrolment target
307
Start
13 Jun 2022
Estimated completion
01 Dec 2028

What is this study about?

This study is testing a new medicine called XmAb®819 for people who have a type of kidney cancer called clear cell renal cell carcinoma (ccRCC). This is an advanced cancer that has either come back after past treatments or didn't get better with those treatments. The main purpose of this study is to see if XmAb®819 is safe and to find out how well people can cope with the medicine and any side effects. Doctors also want to figure out the best amount (dose) of the medicine to give and how often.

The study will involve two main steps. First, a small group of people will receive carefully increasing doses of XmAb®819 so doctors can find a safe and effective starting dose. Then, in the second step, more people will receive that chosen dose to gather more information about safety and effectiveness. The medicine can be given in two ways: either directly into a vein through a drip (intravenous, or IV) or as an injection just under the skin (subcutaneous, or SC). Doctors will decide which way is best for each person involved in the study.

Researchers will be carefully checking how the medicine works in the body and if it has any effect on the cancer. They will also look at how your immune system reacts to the medicine. This is an early-stage study (called Phase 1), which means it's one of the first times this medicine is being tested in humans. The information gathered from this study will help to decide if this medicine should be tested further in larger studies.

Key takeaways

  • It's a new medicine for advanced kidney cancer (clear cell renal cell carcinoma).
  • The main aims are to check safety, side effects, and find the right dose.
  • The medicine can be given by drip or injection under the skin.
  • You'll have regular hospital visits for monitoring and tests.
  • It's an early-stage study, so benefits aren't guaranteed.
  • You can stop participating at any time.

Who may be eligible?

To join this study, people must have clear cell renal cell carcinoma that has either returned or not responded to previous treatments. Doctors need to be able to measure your cancer using scans. You also need to be generally well and able to carry out your normal daily activities without too much difficulty, as assessed by a doctor. It's also important that doctors can get a sample of your tumour tissue for testing.

There are also some reasons why people might not be able to join. For example, if you've already had a similar experimental treatment, or if you've had a bad allergic reaction to other antibody medicines in the past. If you've recently had other cancer treatments, you might need to wait a certain amount of time before joining. People with brain cancer that is causing symptoms or getting worse, or with serious active infections, would also not be able to take part.

Some long-term health conditions, like certain autoimmune diseases, might also prevent you from joining, especially if they are severe or need strong treatments. However, some milder conditions, like vitiligo or well-controlled thyroid problems, might still allow you 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. Do I have clear cell renal cell carcinoma that has come back or not responded to previous treatments?
  2. Can doctors measure my cancer on scans?
  3. Am I generally well and able to do my daily activities?
  4. Have I avoided similar experimental treatments in the past?
  5. Do I have any serious active infections or uncontrolled autoimmune diseases?
  6. Do I have a sample of my tumour tissue available for testing?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new medicine, XmAb®819, either through a drip into your vein or as an injection under your skin. The exact schedule for how often you receive the medicine will be set by the study doctors. You will have regular visits to the clinic so the research team can carefully monitor your health, check for any side effects, and see how the medicine is working. These visits will likely involve physical exams, blood tests, and scans to measure your cancer. The length of time you'll be on the study treatment will vary depending on how you respond to the medicine and if you experience any side effects. You will have follow-up appointments after stopping treatment to continue monitoring your health.

Potential risks and benefits

Taking part in an early-stage study like this means there's no guarantee that the treatment will help your cancer. However, you might benefit from receiving a new treatment that isn't widely available yet, which could potentially slow down or shrink your cancer. As with all medicines, XmAb®819 could cause side effects, some of which may be serious, and some we might not know about yet. The study team will monitor you very closely for any side effects and will explain them to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (23)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Xencor Investigative Site
    Verified postcode
    Phoenix, United States· Recruiting
  • Xencor Investigative Site
    Verified postcode
    Duarte, United States· Recruiting
  • Xencor Investigative Site
    Verified postcode
    Sacramento, United States· Recruiting
  • Xencor Investigative Site
    Verified postcode
    New Haven, United States· Recruiting
  • Xencor Investigative Site
    Verified postcode
    Jacksonville, United States· Recruiting
  • Xencor Investigative Site
    Verified postcode
    Atlanta, United States· Recruiting
  • Xencor Investigative Site
    Verified postcode
    Chicago, United States· Recruiting
  • Xencor Investigative Site
    Verified postcode
    Chicago, United States· Recruiting
  • Xencor Investigative Site
    Verified postcode
    Louisville, United States· Recruiting
  • Xencor Investigative Site
    Verified postcode
    Rochester, United States· Recruiting
  • Xencor Investigative Site
    Verified postcode
    New Brunswick, United States· Recruiting
  • Xencor Investigative Site
    Verified postcode
    New York, United States· Recruiting

Common questions

What type of cancer is this study for?

This study is for advanced clear cell renal cell carcinoma, which is a specific type of kidney cancer that has come back or hasn't responded to previous treatments.

What is XmAb®819?

XmAb®819 is a new medicine being tested in this study. It's given either through a drip into a vein or as an injection under the skin.

Why is this study only for people with advanced cancer?

This is an early-stage study, and new treatments are often first tested in people with advanced cancer who have limited treatment options.

Will I know if the medicine is helping my cancer?

Yes, the study doctors will perform regular scans and tests to monitor your cancer and discuss the results with you.

Can I stop the study at any time?

Yes, you have the right to leave the study at any point, and it will not affect your future medical care.

How to find out more

Chet Bohac, MD

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 XmAb®819 in Subjects With Advanced Clear Cell Renal…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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