A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers
This study is testing a new experimental drug, JNJ-63723283, for people with various advanced cancers, including types of lung cancer, melanoma, kidney, bladder, and bowel cancer. The main goals are to find the safest and most effective dose of the drug and to see how well it helps to shrink or control the cancer. This drug is a type of immunotherapy which works by helping your body's own immune system recognise and fight cancer cells. It's for adults aged 18 and over, and will also look at how the drug behaves in the body and if it has any side effects.
At a glance
What is this study about?
This study is looking into a new medication called JNJ-63723283, which is being developed to treat different types of advanced cancers. When we say 'advanced cancers', it means cancers that have grown or spread and are not easily treated with standard methods. This new drug is a type of immunotherapy, which means it works by helping your body's natural defence system, called the immune system, to find and attack cancer cells more effectively. The study is divided into different parts.
The first part of the study aims to figure out the best dose of JNJ-63723283 to give to patients. This is called the 'recommended Phase 2 dose'. Researchers will carefully increase the dose in small steps to find a balance between the drug working well and keeping side effects to a minimum. Once this dose is found, the later parts of the study will focus on how well this drug actually works against cancer in a larger group of patients with specific types of advanced cancers, such as certain lung cancers, melanoma, and kidney cancer, among others.
This research is important because it could lead to a new treatment option for people living with advanced cancers. By understanding how this drug works, its effects on cancer, and its safety, doctors can learn if it has the potential to improve patients' lives. The information gathered will be used to decide if the drug should be studied further in even larger trials.
Key takeaways
- Tests a new immunotherapy drug (JNJ-63723283) for advanced cancers.
- Aims to find the safest and most effective dose.
- Investigates the drug's activity in various cancers like lung, melanoma, and kidney.
- Involves regular clinic visits, blood tests, and scans.
- Potential for new treatment, but also possible side effects.
Who may be eligible?
To join this study, you would generally need to be at least 18 years old. Your overall health and ability to perform daily activities would be checked, and you would need to be in a reasonably good condition. Your thyroid gland, which produces important hormones, would also need to be working normally. For women who could become pregnant, a pregnancy test would be required to be negative.
There are also some things that would prevent you from joining. For example, if you have other serious uncontrolled health problems like a severe infection, serious heart conditions, or uncontrolled high blood pressure or diabetes. You also wouldn't be able to join if you've previously been treated with similar types of immunotherapy drugs, or if you've recently had other cancer treatments. Also, if you’re pregnant, breastfeeding, or planning to become pregnant, you wouldn't be able 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.
- Are you at least 18 years old?
- Is your overall health generally good, and are you able to manage daily activities?
- Are your thyroid gland hormone levels within the normal range?
- Have you *not* had similar immunotherapy drugs before?
- Are you *not* pregnant or breastfeeding, and not planning to be?
What does participation involve?
Taking part in this study would involve a series of visits to the clinic. Initially, there would be screening tests to confirm you meet all the requirements. Once enrolled, you would receive the study drug, JNJ-63723283, likely through an IV (into a vein). During your time on the study, you would have regular appointments for physical examinations, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. For some parts of the study, a fresh sample of your tumour tissue might be needed before starting the treatment. The total duration of your participation would depend on how your body responds to the treatment and the study plan, but it will involve ongoing follow-up to monitor your health and any long-term effects. The research team will explain the full schedule and commitment.
Potential risks and benefits
Locations (20)
- —Verified postcodeSt Louis, United States
- —Verified postcodePittsburgh, United States
- —Verified postcodeChisinau, Moldova
- —Verified postcodeBialystok, Poland
- —Verified postcodeWarsaw, Poland
- —Verified postcodeMoscow, Russia
- —Verified postcodePyatigorsk, Russia
- —Verified postcodeSaint Petersburg, Russia
- —Verified postcodeBadalona, Spain
- —Verified postcodeBarcelona, Spain
- —Verified postcodeMadrid, Spain
- —Verified postcodeMálaga, Spain
Common questions
What is JNJ-63723283 and how does it work?
JNJ-63723283 is an experimental drug designed to help your immune system fight cancer cells. It's a type of immunotherapy.
What types of cancer is this study for?
This study is for people with various advanced cancers, including certain lung cancers, melanoma, kidney, bladder, and bowel cancers.
Will I receive the new drug, or a placebo?
Everyone in this study will receive the active drug, JNJ-63723283. There is no placebo group in this trial.
How long will I be in the study?
The length of your participation will depend on how you respond to the treatment and the study's plan. The study team will explain the expected duration to you.
What are the main goals of this study?
The main goals are to find the right dose of the drug, check its safety, and see how well it works against different advanced cancers.
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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