A Phase 1/2a, Open-Label, Dose-Escalation and Dose-Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti PD-1-IL2RA-IL2 Fusion Protein) Alone or in Combination with Cemiplimab in Patients with Advanced Solid Organ Malignancies
This study is investigating a new treatment called REGN10597, either on its own or together with an existing medicine called Libtayo. It’s for adults who have advanced solid cancers, specifically melanoma or a type of kidney cancer (clear-cell renal cell carcinoma). The main goals are to understand if the new drug is safe and well-tolerated, what its side effects might be, and if it shows any signs of shrinking tumours. Researchers will also look at how the body handles the new drug. This is an early-stage study, meaning it's one of the first times this new drug is being tested in people to gather important information for future research.
At a glance
What is this study about?
This study is looking into a new medication called REGN10597. It's being tested in adults who have advanced solid cancers, specifically melanoma (a type of skin cancer) or clear-cell renal cell carcinoma (a common type of kidney cancer). The new drug might be given alone or together with another cancer medicine called Libtayo. The main purpose of this research is to see how safe this new drug is, how well people can tolerate it (meaning what side effects they experience), and whether it shows any signs of helping to shrink tumours.
This is a 'first-in-human' study, which means it's one of the very first times this particular drug is being given to people. This early stage of research is crucial for understanding how the drug works in the human body, how it's handled by the body, and what are the right doses to use. Researchers are carefully watching for any side effects and seeing if the new treatment has any positive effects on the cancers.
The study will also measure how long any positive effects last and how the illness progresses over time. By gathering this detailed information, doctors hope to learn if REGN10597 could be a helpful new treatment option for these types of cancers in the future. It's an important step in developing new medicines.
Key takeaways
- This study is testing a new drug (REGN10597) for specific advanced cancers.
- It aims to check the safety, side effects, and early signs of effectiveness of the new drug.
- The new drug might be given alone or with an existing medicine called Libtayo.
- It's an early-stage study, helping scientists learn about the drug in people for the first time.
- Regular hospital visits, blood tests, and scans will be part of taking part.
Who may be eligible?
To join this study, you need to be an adult aged 18 or older. The study is open to both men and women.
You would be considered if you have a type of advanced solid cancer, specifically melanoma or clear-cell renal cell carcinoma (a type of kidney cancer). Advanced means the cancer has spread or isn't responding to standard treatments.
There will also be other specific medical checks and requirements that the study doctors will need to review to make sure the study is safe and suitable for you. This will involve looking at your overall health, other medical conditions, and any previous treatments you've had.
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 18 years old or older?
- Have you been diagnosed with advanced melanoma or clear-cell renal cell carcinoma?
- Are you able to visit the hospital regularly for treatments and check-ups?
- Are you generally in a stable condition with your cancer?
- Have you discussed clinical trials with your doctor?
What does participation involve?
If you decide to take part in this study, you will receive either the new drug REGN10597 on its own, or REGN10597 combined with Libtayo. These medications are given as an infusion, which means they are delivered slowly into your bloodstream, usually through a drip in your arm. The frequency and duration of these infusions will be explained to you by the study team.
You will have regular appointments at the hospital or clinic. These visits will involve various tests, such as blood tests, scans (like CT scans or MRI scans) to check on your cancer, and physical examinations. You will also be asked about any side effects you might be experiencing and how you are feeling generally. The total length of your participation will depend on how you respond to the treatment and the study plan, but it will involve ongoing assessments and follow-up to monitor your health and the treatment's effects.
Potential risks and benefits
Locations (4)
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedFrance
Common questions
What kind of cancers is this study for?
This study is for adults with advanced solid cancers, specifically melanoma (a type of skin cancer) or clear-cell renal cell carcinoma (a type of kidney cancer).
What is Libtayo?
Libtayo is an existing cancer medication that might be given alongside the new drug REGN10597 in this study.
How will the study drugs be given?
The study drugs will be given as an infusion, meaning they will be slowly delivered into your bloodstream, typically through a drip.
What does 'first-in-human' mean?
It means this is one of the very first times this new drug is being tested in people to understand its effects, safety, and correct dosage.
Will I get the new drug or the old one?
You will receive the new drug REGN10597, either on its own or together with Libtayo, depending on which group you are in.
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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