A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers
This research study is investigating a new medication called KFA115. It's being tested alone and in combination with an existing cancer drug, pembrolizumab, for patients with advanced forms of several different cancers. The main goals are to carefully check how safe KFA115 is, how well people tolerate it, and to find the best and safest dose to use. Once a safe dose is found, the study will also look at how effective the treatment might be at shrinkage or slowing the growth of cancer. This is a "Phase 1" study, meaning it's an early step in testing new treatments.
At a glance
What is this study about?
This study is a research project focusing on a new medicine called KFA115. It's designed for people with different types of advanced cancers, including certain lung cancers, skin cancers (melanoma), kidney cancers, ovarian cancers, and some others like breast and head and neck cancers. The study aims to look at KFA115 in two ways: first, on its own, and then in combination with another well-known cancer drug called pembrolizumab.
The main purpose of this early-stage study is to understand the safety of KFA115. Researchers want to see if there are any side effects and how people cope with the treatment. They will also be looking to find the highest dose that is safe enough for patients to take. This is a really important step in developing any new medicine, as it helps establish the right amount of drug to give without causing too many problems.
Once a safe dose is identified, the study will expand to further assess how effective KFA115, either alone or with pembrolizumab, might be against the cancer. This helps doctors learn if the new treatment can shrink tumours or stop them from growing. Taking part in this kind of study helps bring us closer to new treatments for cancer, though it’s important to remember that these are early investigations.
Key takeaways
- This study tests a new drug, KFA115, for advanced cancers.
- It checks KFA115 alone and with another drug called pembrolizumab.
- The main aims are to find the safest dose and check for side effects.
- It's an early-stage (Phase 1) study for various cancer types.
- Participants generally need to have tried other treatments already.
Who may be eligible?
This study is open to adults aged 18 to 100 with certain types of advanced cancer that have spread or returned. To be considered, you would usually have already tried other cancer treatments. For example, some lung cancer patients must have had previous immunotherapy and chemotherapy, and their cancer must have shown some improvement from those treatments before getting worse.
For people with kidney cancer or melanoma, you would typically need to have tried both immunotherapy and another specific type of treatment, and your cancer must have progressed despite these previous treatments. If you have ovarian cancer (a specific type), you might be eligible if you haven't had immunotherapy before and have received one previous treatment for tricky-to-treat cancer.
Other specific cancers like breast cancer (a particular type), certain head and neck cancers, or cancers like anal cancer, mesothelimoa, or thymic cancer might also be eligible, often if you haven't had immunotherapy before or if other standard treatments have been tried. Your medical team will check all the details to see if this study is suitable for your specific situation.
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 between 18 and 100 years old?
- Do you have one of the specific advanced cancers listed (e.g., certain lung, skin, kidney, or ovarian cancers)?
- Have you already received previous cancer treatments, such as chemotherapy or immunotherapy?
- Is your cancer considered advanced, meaning it has spread or returned?
- Are you open to potentially receiving either KFA115 alone or with pembrolizumab?
What does participation involve?
If you decide to take part, you'll be given the study medication, KFA115 (either alone or with pembrolizumab), according to a schedule set by the study doctors. Because this is a Phase 1 study, the amount of KFA115 you receive might be slowly increased for new participants to find the safest dose. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health, side effects, and how well the treatment is working. The study will involve ongoing assessments for a period of time, followed by regular check-ins even after you stop taking the study medication to keep an eye on your health. The total duration of your participation could vary depending on how you respond to the treatment and the study's specific design, but you would be fully informed about the expected commitment.
Potential risks and benefits
Locations (19)
- Massachusetts General Hospital .Verified postcodeBoston, United States
- Massachusetts General HospitalVerified postcodeBoston, United States
- NYU School of MedicineVerified postcodeNew York, United States
- University of Pittsburgh Medical CenterVerified postcodePittsburgh, United States
- SCRI Oncology PartnersVerified postcodeNashville, United States
- Novartis Investigative SiteVerified postcodeToronto, Canada
- Novartis Investigative SiteVerified postcodeGuangzhou, China
- Novartis Investigative SiteVerified postcodeBeijing, China
- Novartis Investigative SiteVerified postcodeLyon, France
- Novartis Investigative SiteVerified postcodeDresden, Germany
- Novartis Investigative SiteVerified postcodeEssen, Germany
- Novartis Investigative SiteVerified postcodeHong Kong, Hong Kong
Common questions
What is KFA115?
KFA115 is a new medication being tested in this study to see if it can help treat various advanced cancers, either on its own or with another drug.
What is 'advanced cancer' in this study?
In this study, 'advanced cancer' generally means that the cancer has spread from where it started (metastatic) or has come back after previous treatments and can't be removed by surgery.
What is a 'Phase 1' study?
A Phase 1 study is one of the first steps in testing a new drug in humans. Its main goal is to find out if the drug is safe, what side effects it might have, and the best dose to use.
Why is pembrolizumab mentioned?
Pembrolizumab is an existing cancer drug, and in this study, doctors are looking at whether combining it with the new drug KFA115 might be a more effective treatment for some cancers.
Will I know if I'm getting KFA115 or KFA115 with pembrolizumab?
This is an 'open-label' study, which means both you and your study doctor will know which treatment you are receiving.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.