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RecruitingPHASE1INTERVENTIONAL

Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors

This study is looking at a new experimental medicine, IPH4502, for people with advanced cancers that have a specific marker called Nectin-4. It's the first time this medicine is being tested in humans, so the main goal is to understand its safety and how well people tolerate it. Researchers will also be looking to see if the medicine shows any early signs of helping to shrink or control the cancer. The study will gradually increase the dose of IPH4502 to find the right amount for future research. This is an important step in developing new treatments for cancer, focusing on understanding the new medicine's effects thoroughly.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Innate Pharma
Enrolment target
145
Start
24 Jan 2025
Estimated completion
01 Apr 2029

What is this study about?

This study is about a new medicine called IPH4502, which is being tested for the very first time in people with advanced solid tumours. Advanced solid tumours are cancers that have grown or spread in the body. The main aim of this study is to find out how safe the medicine is and what side effects it might have. Researchers will also be trying to find the best dose to use in future studies.

Another important part of this research is to see if IPH4502 shows any early signs of helping patients. The study is specifically for people whose cancers have a particular feature called Nectin-4, because the new medicine is designed to target this feature. By understanding how IPH4502 works and how the body handles it, doctors can learn if it's a promising new treatment option.

This type of study, often called a 'Phase 1' study, is crucial for developing new medicines. It's focused on patient safety and understanding the basics of how a new drug behaves in the body, before moving on to larger studies that test how well it works against the cancer.

Key takeaways

  • This is an early study of a new cancer medicine, IPH4502.
  • It's for advanced cancers with a specific marker called Nectin-4.
  • The main goal is to check safety, side effects, and find the right dose.
  • Participants will have regular check-ups and monitoring.
  • It's important to have no other effective treatment options currently available.

Who may be eligible?

To join this study, you would need to have advanced cancer that has spread or can't be removed with surgery. Your cancer would also need to have a specific marker called Nectin-4. You should have already tried other standard treatments for your cancer, but there are no more established treatments currently available that are known to work for your specific type at this stage. You would also need to be generally well enough to take part and have your main body organs working properly.

There are also some reasons why people might not be able to join. For example, if you have cancer that has spread to your brain, serious ongoing infections, or certain heart conditions, you might not be eligible. If you've had major surgery recently, are on certain other medications like strong blood thinners or some steroids, or have a lung condition called interstitial lung disease, you also might not be able to take 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. Do I have advanced cancer that has spread or can't be removed?
  2. Has my doctor confirmed my cancer has the Nectin-4 marker?
  3. Have I already tried standard treatments for my cancer?
  4. Am I generally well, and are my main organs working properly?
  5. Do I have any serious infections, heart problems, or other major health issues?
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, IPH4502. Because it's a first-time-in-human study, you'll have regular hospital visits to check your health, manage any side effects, and see how the medicine is affecting your cancer. These visits will involve blood tests, scans, and other checks. You might also be asked to provide a recent tissue sample from your cancer or have a new small procedure to collect one.

The study will start with a gradual increase in the dose of IPH4502 for different groups of patients to find the safest and most effective amount. The total duration of your participation would depend on how your body reacts to the medicine and how your cancer responds, but you would be regularly monitored throughout. You would also have follow-up appointments after stopping the treatment.

Potential risks and benefits

Taking part in this study may offer the potential benefit of trying a new medicine that could help your cancer, especially if other treatments haven't worked or are no longer available. However, because IPH4502 is new, there's always a risk of unexpected side effects, some of which could be serious. The study team will carefully monitor you for any problems. It's important to remember that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

  • Massachusetts General Hospital - Boston
    Verified postcode
    Boston, United States· Recruiting
  • John Theurer Cancer Center
    Verified postcode
    Hackensack, United States· Recruiting
  • Mount Sinai Tisch Cancer Center
    Verified postcode
    New York, United States· Recruiting
  • NEXT Oncology - Dallas
    Verified postcode
    Dallas, United States· Recruiting
  • NEXT Oncology - Virginia
    Verified postcode
    Fairfax, United States· Recruiting
  • Centre Léon Bérard
    Verified postcode
    Lyon, France· Recruiting
  • Gustave Roussy Cancer Institute
    Verified postcode
    Villejuif, France· Recruiting

Common questions

What is a 'Phase 1' study?

A Phase 1 study is the first time a new medicine is tested in people. The main goals are to check its safety, side effects, and to find the best dose.

What does 'Nectin-4' mean?

Nectin-4 is a specific marker that can be found on some cancer cells. The new medicine, IPH4502, is designed to target this marker.

Will this medicine cure my cancer?

This study is mainly focused on safety and finding the right dose. While we hope for good results, it's too early to know if IPH4502 will cure cancer. We will be looking for early signs of it helping to control the disease.

What are the common side effects of IPH4502?

Since this is a new medicine, we don't know all the potential side effects yet. Patients will be closely monitored for any reactions as the study progresses.

Can I continue my regular medications?

Some medications might interfere with the study medicine. The study team will review all your current medications to ensure it's safe for you to participate.

How to find out more

Innate Pharma

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 "Safety and Tolerability of IPH4502 in Patients With Advanced…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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