IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor
This research study is investigating a new treatment called IMA401 for adults with advanced solid tumours where previous treatments haven't worked or the cancer has returned. The main goals are to find the safest and most effective dose of IMA401, both on its own and when combined with another approved cancer drug, pembrolizumab. We also want to understand any side effects and see if the treatment helps to shrink tumours. To be considered for this study, patients will need to have specific markers called MAGE-A4 and/or MAGE-A8 on their cancer cells, as checked through a special test. This is an early-stage study, meaning we are still learning a lot about this new drug.
At a glance
What is this study about?
This clinical trial is designed to investigate a new treatment called IMA401. This medicine is being tested in adults who have solid tumours – these are cancers that form a lump, rather than being in the blood, like leukaemia. Specifically, it's for people whose cancer has either come back after treatment (recurrent) or hasn't responded to other treatments (refractory). The study aims to understand if IMA401 is safe to use, how well people tolerate it, and if it shows early signs of shrinking tumours.
We're trying out IMA401 in two ways: first, on its own, and then in combination with an existing cancer drug called pembrolizumab. Pembrolizumab is a type of immunotherapy, which works by helping your body's immune system fight cancer. We want to see if combining these two treatments might be more effective. A crucial part of joining this study is that your cancer cells must have specific features, known as MAGE-A4 and/or MAGE-A8. These are like 'tags' on the cancer cells that IMA401 is designed to target, so we need to check for them before you can take part.
This is a Phase 1 study, which is the first step in testing a new medicine in people. This means we are primarily focused on finding the right dose of IMA401 that is both safe and has manageable side effects. We also collect information about how the body handles the drug and look for any early indications that it might be helping to fight the cancer. The information we gather will help us decide if this treatment should be studied further in larger trials.
Key takeaways
- Tests a new drug, IMA401, for advanced solid cancers.
- For cancers that have returned or not responded to other treatments.
- Looks at IMA401 alone and with an existing drug, pembrolizumab.
- Requires specific markers (MAGE-A4/A8) on cancer cells.
- First stage of human testing, focusing on safety and finding the right dose.
Who may be eligible?
To join this study, you must be at least 18 years old and have a solid tumour that has either come back or hasn't responded to standard treatments. Your medical team will need to confirm the type of cancer you have, and importantly, lab tests will need to show that your tumour cells have specific markers called MAGE-A4 and/or MAGE-A8. You should generally be feeling well enough to take part, meaning you can mostly look after yourself and are active, with a good estimated life expectancy.
There are also some things that would mean you can't join. For example, if you have other ongoing cancers that need treatment, or if you've had a recent organ or stem cell transplant. Also, if you have certain serious or uncontrolled health conditions, including some autoimmune diseases, or if you've had a bad reaction to similar medicines in the past, you might not be eligible. The study team will review your full medical history to make sure taking part is 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.
- Are you 18 years old or older?
- Do you have a solid tumour that has come back or not responded to previous treatments?
- Has your doctor confirmed your cancer has the MAGE-A4 and/or MAGE-A8 markers?
- Are you generally well and active enough for daily tasks?
- Do you have adequate organ function (kidneys, liver, etc.)?
- Do you have any other active cancers or serious autoimmune conditions?
What does participation involve?
Information on participation is limited in the provided text. Typically, taking part in a clinical trial involves regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is working. You would receive the study medication (IMA401, potentially with pembrolizumab) at specific times. The duration of treatment and follow-up would be determined by the study design and your response. The overall commitment would include attending all scheduled appointments and reporting any side effects.
Potential risks and benefits
Locations (21)
- Universitaetsklinikum Freiburg, Zentralklinikum, Klinik fuer Innere Medizin IVerified postcodeFreiburg im Breisgau, Germany
- Universitaetsklinikum Heidelberg AöR, Nationales Zentrum fuer TumorkrankheitenVerified postcodeHeidelberg, Germany
- Thoraxklinik Heidelberg gGmbH, Studienzentrum ThoraxonkologieVerified postcodeHeidelberg, Germany
- Universitaetsklinikum Tuebingen AöR, Comprehensive Cancer Center TuebingenVerified postcodeTübingen, Germany
- Universitaetsklinikum Ulm AöR, ECTU-Early clinical Trials Unit Universitaetsklinikum Ulm Comprehensive Cancer Center Ulm_CCCUVerified postcodeUlm, Germany
- Universitaetsklinikum Erlangen AöR, Interdisciplinary Clinical Trial Unit with ECTUVerified postcodeErlangen, Germany
- Klinikum rechts der Isar der TU Muenchen AöR, Klinik und Poliklinik fuer Innere Medizin IIIVerified postcodeMunich, Germany
- Klinikum Nuernberg, Klinik fuer Innere Medizin 5, Abteilung Onkologie/HaematologieVerified postcodeNuremberg, Germany
- Universitaetsklinikum Regensburg AöR, Klinik fuer Innere Medizin 3Verified postcodeRegensburg, Germany
- Universitaetsklinikum Wuerzburg AöR, Interdisziplinaeres Studienzentrum mit ECTUVerified postcodeWürzburg, Germany
- Goethe Universitaetsklinikum Frankfurt AöR, Medizinische Klinik IIVerified postcodeFrankfurt am Main, Germany
- Medizinische Hochschule Hannover, Klinik fuer Haematologie, Haemostaseologie, Onkologie und StammzelltransplantationVerified postcodeHanover, Germany
Common questions
What is a 'solid tumour'?
A solid tumour is a mass of abnormal tissue that usually doesn't contain cysts or liquid areas. Most cancers, other than blood cancers, form solid tumours.
What does 'recurrent and/or refractory' mean?
'Recurrent' means the cancer has come back after treatment. 'Refractory' means the cancer has not responded to previous treatments.
What are MAGE-A4 and MAGE-A8?
These are specific proteins or 'markers' that can be found on the surface of some cancer cells. The new drug, IMA401, is designed to specifically target cancer cells that have these markers.
What is Pembrolizumab?
Pembrolizumab is an approved immunotherapy that helps your body's own immune system find and fight cancer cells. It's sometimes called a 'checkpoint inhibitor'.
Why is this called a 'Phase 1' study?
Phase 1 is the first stage of testing a new drug in people. The main goals are to find a safe dose, understand how it affects the body, and check for any early signs that it might be working.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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