All studies
Active not recruitingPHASE1INTERVENTIONAL

Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer

This research is looking at an experimental treatment called botensilimab, which is a type of antibody designed to fight cancer. Sometimes it's given on its own, and sometimes it's combined with another drug called balstilimab. The study is for people with different types of advanced cancers that have not improved with standard treatments. The main goals are to check if the treatment is safe, how the body handles it, and to figure out the most effective and safest dose. Researchers also want to see how well these drugs work against various cancers, including lung, ovarian, prostate, and certain bowel cancers. This early-stage study isn't about finding a cure, but about gathering important information to potentially help future patients.

At a glance

Status
Active not recruiting
Phase
PHASE1
Sponsor
Agenus Inc.
Enrolment target
499
Start
20 Mar 2019
Estimated completion
01 Dec 2027

What is this study about?

This study is a very early-stage clinical trial, called a Phase 1 study. Its main purpose is to learn more about a new medicine called botensilimab, and sometimes how it works when given with another drug called balstilimab. Imagine your body's immune system as an army that fights off diseases. Cancer cells sometimes have ways of hiding from this army. Botensilimab is designed to help the immune system recognise and attack cancer cells more effectively. Balstilimab works in a similar way, alongside the body's natural defences.

Doctors want to find out if these medicines are safe, whether people can tolerate them well, and how the body processes them. They also need to discover the correct dose to give by slowly increasing the amount given to different groups of patients. By carefully watching how people react, they aim to find the dose that is most likely to be helpful while keeping side effects manageable.

The study involves people with various types of advanced cancer, where other treatments haven't worked or are no longer an option. This includes cancers like non-small cell lung cancer, ovarian cancer, prostate cancer, certain types of bowel cancer, and others like endometrial cancer and a rare liver cancer called fibrolamellar carcinoma. This research is a crucial step towards developing new treatments, but it's important to remember that it's still very early days, and the main focus is on safety and finding the right dose, rather than on curing the cancer at this stage.

Key takeaways

  • New experimental treatment for advanced cancers.
  • Aims to improve your immune system's ability to fight cancer.
  • Focuses on safety, how the body handles the drugs, and finding the right dose.
  • For those whose cancers haven't responded to standard treatments.
  • Participation could last up to two years.
  • You can stop participating at any time.

Who may be eligible?

To be considered for this study, you would first need to sign a consent form, showing you understand what's involved. You must have an advanced solid cancer that has either spread or grown locally, and for which standard treatments haven't worked or aren't suitable for you.

Doctors will need to confirm that your cancer can be measured on scans (except for prostate cancer). You also need to be reasonably fit, able to carry out your daily activities, and doctors expect you to live for at least three more months.

Finally, essential organs like your liver, kidneys, and bone marrow need to be working well, which will be checked with blood tests. A recent tissue sample from your cancer will also be needed for the study.

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 I been diagnosed with an advanced solid cancer?
  2. Have standard cancer treatments not worked for me or are no longer options?
  3. Am I generally well enough to do most daily activities for myself?
  4. Are my liver, kidney, and blood tests within healthy ranges?
  5. Am I at least 18 years old?
  6. Do I have a recent cancer tissue sample available?
Answer every question to see your result.

What does participation involve?

If you join this study, you’ll receive the experimental treatment (botensilimab, either alone or with balstilimab) for up to two years. The dose you receive will depend on which study group you are placed in. You’ll have regular check-ups, scans, and blood tests to monitor your health, how the treatment is working, and to check for any side effects. Treatment will stop if your cancer gets worse, if you experience side effects that are too difficult to manage, or if you or the doctors decide it's best to stop. The exact duration of your visits and tests will be explained in detail by the study team.

Potential risks and benefits

As with any new medicine, there are potential benefits and potential risks. The potential benefit is that these new drugs might slow down or shrink your cancer, or improve your quality of life, especially since other treatments haven't worked for you. However, there's no guarantee this will happen, and your health might not improve. Potential risks include side effects from the drugs, which could be mild or severe, and these will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (18)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • HonorHealth Research Institute
    Verified postcode
    Scottsdale, United States
  • City of Hope Comprehensive Cancer Center
    Verified postcode
    Duarte, United States
  • The Angeles Clinic & Research Institute, a Cedars-Sinai Affiliate
    Verified postcode
    Los Angeles, United States
  • University of Southern California Norris Comprehensive Cancer Center
    Verified postcode
    Los Angeles, United States
  • UCLA Santa Monica Hematology Oncology
    Verified postcode
    Los Angeles, United States
  • Saint John's Cancer Institute
    Verified postcode
    Santa Monica, United States
  • University of Colorado
    Verified postcode
    Aurora, United States
  • Yale Cancer Center
    Verified postcode
    New Haven, United States
  • University of Miami Sylvester Comprehensive Cancer Center
    Verified postcode
    Miami, United States
  • Beth Israel Deaconess Medical Center
    Verified postcode
    Boston, United States
  • Dana-Farber Cancer Institute
    Verified postcode
    Boston, United States
  • Icahn School of Medicine at Mount Sinai
    Verified postcode
    New York, United States

Common questions

What does 'Fc-Engineered Anti-CTLA-4 Monoclonal Antibody' mean in simple terms?

It refers to a new type of drug designed to help your body's immune system fight cancer. It's like a specially made key that unlocks your immune cells so they can attack cancer better.

What is the difference between botensilimab and balstilimab?

Both are medicines that help your immune system, but they work in slightly different ways. Botensilimab is the main drug being studied, and balstilimab is sometimes given alongside it to see if they work better together.

Why is this only a 'Phase 1' study?

Phase 1 is the first step in testing a new medicine in people. It primarily checks for safety, how the body handles the drug, and helps doctors find the best dose before moving on to larger studies.

Will I definitely get the drug if I join?

Yes, if you meet all the criteria and decide to join, you will receive the study treatment (either botensilimab alone or with balstilimab). This is not a study where you might receive a dummy treatment (placebo).

What happens after the study ends?

The study aims to gather information about the treatment. If the study suggests the drugs are safe and potentially effective, they might move to later phases of testing. Your personal care after the study will be discussed by your medical team.

How to find out more

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

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