Phase 1/2 Clinical Trial of S227928, an Anti-CD74 Antibody-Drug Conjugate Targeting MCL-1, as a Single Agent and in Combination with Venetoclax in Patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)/AML, or Chronic Myelomonocytic Leukemia (CMML)
This study is looking into a new treatment called S227928, which is an antibody-drug conjugate. It's being tested on its own and in combination with an approved medicine, venetoclax (Venclyxto). The trial is for adults suffering from specific types of blood cancers: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)/AML, or Chronic Myelomonocytic Leukemia (CMML), where their cancer has either come back or hasn't responded to earlier treatments. The main goals are to find a safe dose of the new drug, understand its side effects, and see if it helps patients achieve remission.
At a glance
What is this study about?
This study is an early-stage clinical trial looking at a new medicine called S227928. It's designed for people with specific blood cancers – Acute Myeloid Leukaemia (AML), Myelodysplastic Syndromes (MDS) that have turned into AML, or Chronic Myelomonocytic Leukaemia (CMML). These are cancers where the body makes too many abnormal blood cells. The study is specifically for patients whose cancer has either come back after treatment or didn't get better with their previous treatments. The new medicine, S227928, works by targeting specific proteins on cancer cells, aiming to deliver a powerful cancer-killing drug directly to them, much like a 'guided missile'.
Researchers want to see if S227928 is safe and if it can help stop the cancer from growing. They are testing it in two ways: first, on its own, and then alongside an existing cancer drug called venetoclax, which is often known as Venclyxto. Venetoclax works by targeting a different protein in cancer cells, so the hope is that combining these two medicines might be more effective than either one alone.
This trial has two main parts, Phase I and Phase II. In Phase I, the focus is on finding the right dose of S227928 and understanding its side effects. In Phase II, once a safe dose is found, the researchers will look closer at how well the treatment helps patients achieve remission, meaning their cancer shows signs of shrinking or disappearing. Understanding these early-stage trials helps pave the way for potential new treatments for these challenging blood cancers.
Key takeaways
- This study tests a new treatment (S227928) for specific blood cancers.
- It's for adults whose cancer has returned or didn't respond to previous treatments.
- The new medicine is given alone or with an existing drug, venetoclax (Venclyxto).
- Early stages focus on finding a safe dose and understanding side effects.
- Participation involves regular hospital visits, tests, and closely monitoring your health.
Who may be eligible?
To be considered for this study, you must be an adult, aged 18 or older.
You must have been diagnosed with one of these specific types of blood cancer: Acute Myeloid Leukaemia (AML), Myelodysplastic Syndrome (MDS) that has turned into AML, or Chronic Myelomonocytic Leukaemia (CMML). Importantly, your cancer must have either returned after previous treatment or not responded to the treatments you've had before.
There might be other health requirements or previous treatment restrictions that the study doctors will discuss with you to make sure the trial is safe and appropriate for your specific situation.
- Are you 18 years old or older?
- Do you have Acute Myeloid Leukaemia (AML), MDS/AML, or Chronic Myelomonocytic Leukaemia (CMML)?
- Has your cancer come back or not responded to previous treatments?
- Are you able to attend regular hospital visits for treatment and check-ups?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will receive the new medicine, S227928, which is given as an infusion (drip). Depending on which part of the study you are in, you might also take venetoclax (Venclyxto) tablets and other supporting medicines like Zyloric or Fasturtec. These are taken by mouth or given as an infusion.
Throughout the study, you will have regular hospital visits. These visits will involve various tests to check your health and how the treatment is working. This includes blood tests, physical examinations, heart checks (like ECGs and echocardiograms), and monitoring for any side effects. The study will continue for several treatment cycles, and doctors will carefully track your progress and well-effects. You can withdraw from the study at any time.
Potential risks and benefits
Locations (3)
- —Finland
- —Germany
- —France
Common questions
What is an antibody-drug conjugate (ADC)?
It's like a 'guided missile' drug. An antibody targets specific cancer cells, and it's attached to a powerful medicine that gets delivered directly to those cells.
What is the new medicine S227928?
S227928 is an experimental medicine being tested to see if it can help treat certain blood cancers by targeting specific proteins on the cancer cells.
What is venetoclax (Venclyxto)?
Venetoclax is an approved medicine that works by targeting a different protein in cancer cells to help cause their death. It's being tested in combination with S227928 in this study.
What does 'relapsed/refractory' mean?
It means your cancer has either come back after past treatments (relapsed) or didn't respond adequately to previous treatments (refractory).
What is the main goal of Phase I of the study?
The main goal of Phase I is to find a safe dose of the new medicine and understand its potential side effects.
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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