A Phase 1/2, Open-Label, Multicenter, Multi-cohort Study of S241656 as Monotherapy or in Combination with other Antileukemic Agents in participants with Selected Myeloid Malignancies
This phase 1/2 clinical trial is studying an experimental medicine called S241656. The treatment is taken as a tablet by adults who have specific types of blood cancer, such as acute myeloid leukaemia (AML) and chronic myelomonocytic leukaemia (CMML). Because S241656 is a new drug, the main goal of the study is to find out if it is safe and to work out the most suitable dose. Doctors will monitor participants closely for any side effects and measure how the drug moves through the body. The trial also looks at what happens when S241656 is taken alongside posaconazole, a medicine commonly used to prevent fungal infections in people with blood conditions. In addition, doctors will track whether the treatment helps reduce cancer cells in the bone marrow and improves healthy blood cell counts.
At a glance
What is this study about?
Acute myeloid leukaemia (AML) and related conditions, like chronic myelomonocytic leukaemia (CMML), are cancers that affect the bone marrow and blood. In these conditions, the bone marrow produces abnormal, immature blood cells that cannot do their normal jobs. These unhealthy cells crowd out normal blood cells, which can cause severe tiredness, frequent infections, and easy bleeding or bruising. While there are existing treatments, they do not work for everyone, so researchers are looking for new options.
This clinical study is investigating a new tablet called S241656. It is an early-stage study designed to check the safety of the drug and to discover the best dose to give to patients. Doctors will carefully track any side effects and run laboratory tests to see how the body absorbs, breaks down, and clears the medicine over time.
The trial also tests how S241656 behaves when taken with posaconazole. Posaconazole is an antifungal medication often prescribed to people having leukaemia treatment to protect them from serious infections. Because medicines can sometimes affect how the liver processes one another, doctors need to check if posaconazole changes the levels of S241656 in the bloodstream.
Throughout the trial, doctors will also watch for early signs that the medicine is working. They will examine bone marrow samples and blood counts to see if the treatment helps clear cancer cells and reduces the need for blood transfusions.
Key takeaways
- Tests a new oral tablet called S241656 for adults with specific myeloid blood cancers.
- A phase 1/2 trial focused on finding the right dose and checking safety.
- Examines how the medicine works alone and when taken with an antifungal drug.
- Aims to find out if the drug can reduce cancer cells in the bone marrow.
- Participation is entirely voluntary and involves regular hospital visits for monitoring.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with specific myeloid blood cancers. These include acute myeloid leukaemia (AML), chronic myelomonocytic leukaemia (CMML), or advanced myelodysplastic syndrome (MDS/AML).
Because this is an early-phase trial testing a new medicine, there are strict safety rules. Participants must have reasonably good general health and acceptable organ function, including healthy kidney and liver test results, to ensure they can safely take the study drug.
The study team will review your full medical history, including any previous cancer treatments you have had. People with certain serious medical conditions, or those who are pregnant or breastfeeding, will not be able to take part.
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.
- I am aged 18 or older.
- I have been diagnosed with AML, CMML, or MDS/AML.
- I am able to swallow tablets.
- I am well enough to attend regular hospital appointments for check-ups and tests.
- I am willing to have blood tests and bone marrow checks during the study.
What does participation involve?
Taking part in this study means visiting a specialist hospital clinic regularly. You will be given the study drug, S241656, as a tablet to swallow at home or at the clinic. Depending on the part of the trial you join, you may take S241656 alone or alongside posaconazole. During your visits, you will have physical examinations, blood tests, heart checks (ECGs), and occasional bone marrow tests. These check your health, measure drug levels, and monitor your cancer. You can usually continue taking the study drug for as long as it is helping your condition and any side effects are manageable. After treatment stops, the study team will continue to check on your health during follow-up visits.
Potential risks and benefits
Locations (6)
- —UnverifiedNetherlands
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedFinland
Common questions
What is the main goal of this clinical trial?
The main goal is to find out if the new tablet S241656 is safe, determine the best dose, and see if it can help treat certain blood cancers.
How is the study medicine taken?
S241656 is taken by mouth as a tablet, which comes in 25 mg and 50 mg strengths.
Why is posaconazole used in part of this study?
Posaconazole is a common medicine used to prevent fungal infections. Doctors want to check whether it changes how S241656 is broken down by the body.
Will I receive a dummy pill (placebo)?
No. This is an open-label trial, meaning there is no placebo and every participant receives the active study treatment.
How will the doctors know if the treatment is working?
Doctors will check your blood counts, test your bone marrow, and see if you need fewer blood or platelet transfusions.
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.