Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies
This research study is investigating a new medication called CCS1477 (or inobrodib) for patients who have specific types of blood cancer. These include Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia, and certain types of Myelodysplastic Syndrome. The study is split into two main parts: Phase 1 and Phase 2a. In Phase 1, researchers will carefully check the safety of CCS1477, how well patients tolerate it, and how the body handles the drug. Phase 2a will then continue to look at safety and will also see if the drug shows any positive effects on the cancer. The aim is to find out if this new treatment could be a helpful option in the future for people whose cancers have come back or haven't responded to previous treatments.
At a glance
What is this study about?
This study is looking into a new medication called CCS1477, also known as inobrodib. It's designed for people who have certain types of blood cancers, such as Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia, and a specific type of Myelodysplastic Syndrome. These are cancers that affect your blood cells.
The main goal of this research is to see how safe the new drug CCS1477 is and how well people tolerate it. The study will also look at how your body processes the drug and if it has any positive effects on the cancer. This is important because it helps doctors understand if CCS1477 could be a useful new treatment, especially for patients whose cancer hasn't responded to earlier treatments or has returned.
This study is in its early stages (Phase 1 and Phase 2a). This means it's one of the first times this drug is being tested in a larger group of people. The information gathered from this study will be crucial in deciding if and how this medication should be developed further, potentially offering new hope for patients living with these blood cancers.
Key takeaways
- This study evaluates a new drug, CCS1477, for specific blood cancers.
- It aims to assess the drug's safety, tolerability, and effectiveness.
- The study is for adult patients whose cancer has returned or didn't respond to previous treatment.
- You'll be closely monitored by a medical team.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you would need to be an adult, aged 18 or over. You must have a confirmed diagnosis of certain blood cancers like Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia, or a specific type of Myelodysplastic Syndrome, and your cancer must have either come back or not responded to standard treatments. You also need to be generally well enough to take part, meaning you can do most of your normal daily activities without too much difficulty, and your body organs like your liver and kidneys are working properly.
There are also some reasons why you might not be able to join. For example, if you've recently had chemotherapy, other anti-cancer treatments, or major surgery, there would be a waiting period before you could start. You also can't be taking certain medications that might interfere with how the study drug works, including some strong medications that affect your liver or cholesterol-lowering drugs (statins) which would need to be stopped before starting the study. The study also cannot include people with uncontrolled illnesses or certain heart conditions.
- Are you 18 years old or older?
- Do you have Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia, or high-risk Myelodysplastic Syndrome?
- Has your cancer come back or not responded to previous treatments?
- Are you generally well and able to manage most daily activities?
- Do your main body organs (like kidneys and liver) work well?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
The details of what specific assessments or visits are involved are not fully outlined in this summary. However, typically in studies like this, you would likely have regular appointments at the clinic for check-ups. These visits might include blood tests to see how the drug is affecting your body and the cancer, physical examinations, and scans. You would be given the study medication, CCS1477, and possibly other approved medications depending on the study group you are in. The total duration of your participation would be explained by the study team, and there would usually be a follow-up period after you stop taking the study medication to monitor your health. All aspects of your care and the reasons for your visits will be explained in detail by the study team.
Potential risks and benefits
Locations (39)
- Emory Winship Cancer InstituteAtlanta, United States· Recruiting
- Community Health NetworkIndianapolis, United States· Recruiting
- The Center for Cancer and Blood Disorders (CCBD)Bethesda, United States· Recruiting
- Nebraska Cancer SpecialistsOmaha, United States· Recruiting
- University of Nebraska Medical CenterOmaha, United States· Recruiting
- Penn Medicine - Abramson Cancer Center PerelmanPhiladelphia, United States· Recruiting
- Institute BergonieBordeaux, France· Completed
- Gustave RoussyVillejuif, France· Completed
- Hospital Germans Trias i Pujol/ ICO BadalonaBadalona, Spain· Recruiting
- University Hospital Vall D'HebronBarcelona, Spain· Completed
- Hospital Clínic de BarcelonaBarcelona, Spain· Recruiting
- ICO L'Hospitalet (Instituto Catalán de Oncología)Barcelona, Spain· Recruiting
+27 more sites — see the official record for the full list.
Common questions
What kind of blood cancers is this study for?
This study is for specific types of blood cancer, including Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia, and certain types of Myelodysplastic Syndrome.
What is CCS1477 (inobrodib)?
CCS1477, also called inobrodib, is a new medication being tested in this study to see if it can help treat these blood cancers.
What are the main goals of this study?
The main goals are to find out if CCS1477 is safe, how well people tolerate it, and how it works in the body and on the cancer.
Can I join if I've had previous cancer treatment?
Yes, this study is for people whose cancer has come back or hasn't responded to previous standard treatments, as long as you meet other health requirements.
What are Phase 1 and Phase 2a studies?
These are early stages of clinical research. Phase 1 mainly focuses on safety and dosage, while Phase 2a continues to look at safety and checks for signs that the drug might be effective.
How to find out more
Tomasz Knurowski, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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