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Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A study to investigate the safety, the amount that reaches the bloodstream and the effects on the body of JNJ-64619178 in people with advanced cancers

This research study is looking at a new experimental medicine called JNJ-64619178. It's designed for adults who have advanced cancer, specifically lymphoma (a type of blood cancer) or other solid tumours, and have already had treatments for their cancer. The main goals are to find out if the medicine is safe, how much of it reaches the bloodstream, and what effects it has on the body. This is an early phase of research, which means it's among the first times this new medicine is being given to people. The information gathered will help doctors understand more about this potential new treatment.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Janssen Cilag International
Enrolment target
74
Start
28 Aug 2024

What is this study about?

This study is about a new medicine called JNJ-64619178. When doctors discover new medicines, they need to test them very carefully to make sure they are safe and that they work. This particular study is in an early stage, which we call Phase 1. This means it's one of the first times this new medicine is being given to people. The main purpose is to learn important things like how safe it is, how much of the medicine gets into your body and how it moves around, and what effects it has on different body systems.

This new medicine is being tested in adults who have advanced cancer. This includes people with lymphoma, which is a type of blood cancer, and also people with other types of solid tumours. All participants in this study would have already received other treatments for their cancer in the past. Researchers want to see if this new medicine could offer another way to help people with these conditions.

The information gathered from this study is really important. It helps doctors understand if JNJ-64619178 could be a promising treatment for cancer in the future. If the results show it's safe and has positive effects, it could then move on to bigger studies with more people to see if it can help fight cancer effectively.

Key takeaways

  • This study is for a new experimental cancer medicine.
  • It's an early-stage study focused on safety and how the medicine works in the body.
  • It's for adults with advanced lymphoma or other solid tumours who have had previous treatments.
  • You will have regular check-ups by doctors and nurses.
  • Participation is voluntary, and you can stop at any time.

Who may be eligible?

To be part of this study, you need to be an adult, at least 18 years old. People of any gender can take part.

This study is for people who have advanced cancer. This specifically includes people with a type of blood cancer called lymphoma, or with other solid tumours. An important part of joining is that you must have already had treatments for your cancer in the past.

There will be other specific health requirements that only the study doctors can explain and check. They will review your full medical history to make sure that the study is right and safe 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 18 years old or older?
  2. Have you been diagnosed with advanced lymphoma or another advanced solid tumour?
  3. Have you already received other treatments for your cancer?
  4. Are you comfortable with regular hospital visits and medical tests?
Answer every question to see your result.

What does participation involve?

If you decide to participate, you would receive the new study medicine, JNJ-64619178. The study involves regular visits to the clinic where doctors and nurses will monitor your health very closely. They will perform examinations, take blood and urine samples, and ask you questions about how you are feeling. This helps them understand how the medicine is affecting your body.

The total length of time you would be involved in the study can vary. You would continue to receive the medicine and attend clinic visits for a certain period, and then there would be follow-up appointments to check on your health even after you stop taking the medicine. The study team will explain the full schedule of visits and treatments tailored to your situation.

Potential risks and benefits

Taking part in any study has potential benefits and risks. The potential benefit of this study is that the new medicine might help with your cancer, even though it's still very early in its testing, or it might help researchers learn more to develop better treatments for others in the future. As with all new medicines, there's always a risk of side effects, which the doctors will explain to you and monitor carefully. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Spain

Common questions

What kind of cancer is this study for?

This study is for adults with advanced cancers, specifically lymphoma (a blood cancer) or other advanced solid tumours.

What does 'advanced cancer' mean?

Advanced cancer usually means cancer that has spread or progressed despite previous treatments.

What is a 'Phase 1' study?

A Phase 1 study is a very early stage of research, where a new medicine is given to people for the first time to primarily check its safety and how it behaves in the body.

Will this medicine cure my cancer?

It's not known if this medicine will cure cancer. This early study aims to understand its safety and effects, not primarily if it's a cure.

Can I stop participating if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect the care you receive from your doctors.

How to find out more

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

Discussion

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