A first-in-human, Phase 1, Dose Escalation Study of SGR-2921 as Monotherapy in subjects with relapsed/refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
This is a very early study, called a Phase 1 trial, looking at a new medicine called SGR-2921. It's the first time this medicine is being given to people. The study is for adults over 18 who have Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS). These are types of blood and bone marrow cancers. Participants in this trial have already tried other treatments that haven't worked or stopped working. The main goal is to find out if SGR-2921 is safe and to determine the best dose to give. Researchers will also be checking to see if the new medicine has any positive effects on the conditions. Both men and women can take part.
At a glance
What is this study about?
This study is a pioneering step in medical research. It's designed to introduce a brand-new medicine, called SGR-2921, to human volunteers for the very first time. You might hear this described as a 'first-in-human' study or a 'Phase 1' trial. Such trials are crucial for understanding how a new medicine behaves in the body, its potential side effects, and what dose might be most effective and safest.
The specific conditions this study focuses on are Acute Myeloid Leukaemia (AML) and Myelodysplastic Syndrome (MDS). These are both serious types of blood cancer that affect the bone marrow, which is where new blood cells are made. In these conditions, the bone marrow doesn't produce healthy blood cells properly. The study is particularly for individuals whose cancer has returned after treatment (relapsed) or hasn't responded to previous treatments (refractory).
The main purpose of this early study is not yet to cure the conditions, but rather to carefully check if SGR-2921 is safe for people to use and to work out the most appropriate dose. By doing this, researchers hope to lay the groundwork for future studies that could eventually lead to new treatment options for people living with AML and MDS.
Key takeaways
- This is an early study of a brand-new medicine, SGR-2921.
- It's for adults with specific blood cancers (AML or MDS) where previous treatments haven't worked.
- The main goal is to find a safe dose and understand how the medicine works.
- Participation involves regular visits and careful monitoring by a medical team.
- You have the right to leave the study at any time without affecting your normal care.
Who may be eligible?
This study is looking for adult participants, meaning you must be at least 18 years old. There's no upper age limit. Both men and women are welcome to take part.
You would be considered for this study if you have been diagnosed with either Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS). A key requirement is that your condition has either come back after previous treatment or has not responded well to treatments you've already tried. This means that current standard treatments may not be working for you.
There will be other detailed medical checks to make sure this study is right for you and safe for your health. Your doctor will carefully review your full medical history and current health status to confirm if you meet all the necessary criteria.
- Are you 18 years old or older?
- Do you have a diagnosis of Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS)?
- Has your AML or MDS either returned or not responded to previous treatments?
- Are you able to attend regular hospital or clinic visits for monitoring?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
Taking part in this study would involve regular visits to the hospital or clinic. These visits are essential for the research team to closely monitor your health, check for any side effects, and see how your body is responding to the new medicine. You would receive the study medicine, SGR-2921, as a single treatment. The study is designed to carefully increase the dose for different groups of participants until a safe level is found.
During your visits, you would have various assessments, which might include blood tests, urine tests, physical examinations, and possibly scans or bone marrow biopsies, to check your condition and how the medicine is affecting you. After receiving the medicine, there will be a follow-up period where the research team will continue to monitor your health. The total duration of your participation in the study, including the treatment and follow-up, will be clearly explained by the study team, but typically involves several months of dedicated monitoring.
Potential risks and benefits
Locations (2)
- —Spain
- —France
Common questions
What is a 'first-in-human' study?
It means this is the very first time the new medicine, SGR-2921, is being given to people, usually after extensive testing in laboratories and animals.
What are AML and MDS?
AML (Acute Myeloid Leukaemia) and MDS (Myelodysplastic Syndrome) are types of blood and bone marrow cancers where the body doesn't make healthy blood cells properly.
Why is this study only for people whose treatment hasn't worked?
Because this is a very early-stage trial, it often focuses on patients who have limited treatment options left, to understand the new medicine's effects in this specific group.
Will I get the new medicine or a placebo?
As this is a dose-escalation study (finding the right dose), all participants will receive the active study medicine, SGR-2921, not a placebo.
How long will I be in the study?
The exact duration will vary, but usually involves several months of treatment and follow-up. The study team will explain the full timeline to you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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