Study of S227928 Alone and with Venetoclax for Patients with Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for certain types of blood cancers. The diseases being studied include Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Chronic Myelomonocytic Leukemia (CMML). The treatment involves a new medication called S227928, which is an anti-CD74 antibody-drug conjugate. This means it is a special type of medicine designed to target and attack cancer cells. The study will also look at how S227928 works when used alone and when combined with another medication called Venetoclax, which is already used to treat some types of blood cancers.

The purpose of this study is to understand how safe and effective S227928 is for patients with these specific blood cancers, especially those whose disease has returned or has not responded to previous treatments. The study will be conducted in two phases. In the first phase, researchers will focus on finding the safest dose of S227928 and how well patients tolerate it, both on its own and in combination with Venetoclax. In the second phase, the study will evaluate how well the combination of S227928 and Venetoclax works in fighting the cancer.

Participants in the study will receive the treatment and be monitored closely by healthcare professionals. The treatment will be given either as a tablet or through an intravenous infusion, which means it will be delivered directly into the bloodstream. The study aims to gather important information about the treatment’s effects on the body, including any side effects and how the body processes the medication. This information will help determine if S227928 could be a beneficial treatment option for patients with these challenging blood cancers.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes a review of medical history and a physical examination.

Blood tests and other laboratory evaluations are conducted to ensure adequate renal and hepatic function.

2 phase 1 treatment

The first phase focuses on evaluating the safety and tolerability of the drug S227928 as a single agent and in combination with venetoclax.

Participants receive S227928 through intravenous infusion. The dosage is adjusted to determine the maximum tolerated dose.

Participants also take venetoclax in the form of 100 mg film-coated tablets, administered orally.

3 monitoring and evaluation

Throughout the treatment, participants are monitored for any adverse effects. This includes regular checks of vital signs, physical examinations, and laboratory tests.

Cardiac evaluations such as electrocardiograms (ECG) and echocardiograms (ECHO) are performed to monitor heart health.

4 phase 2 treatment

In the second phase, the focus shifts to assessing the anti-leukemic activity of S227928 in combination with venetoclax.

Participants continue to receive the combination treatment, with adjustments made based on the findings from phase 1.

5 follow-up

After completing the treatment phases, participants enter a follow-up period.

Regular assessments are conducted to evaluate the long-term effects of the treatment and overall health status.

Who Can Join the Study?

You must be an adult, which means you need to be at least 18 years old.
Your performance status, which is a measure of your general well-being and ability to carry out daily activities, should be 2 or less. In some European countries, it must be 0 or 1.
You need to provide written informed consent, which means you agree to participate in the study after understanding all the details.
You must have a confirmed diagnosis of one of the following conditions: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)/AML, or Chronic Myelomonocytic Leukemia (CMML). These are types of blood cancers.
You should have been treated with at least one standard treatment before and have a disease that has come back or not responded to treatment. You should not be a candidate for further standard therapy.
Your circulating leukocytes, which are white blood cells, should be less than 10 x 10⁹/L. You can use a medication called hydroxycarbamide to help meet this requirement before starting the study drug.
You need to have adequate kidney and liver function within 7 days before joining the study. This means your kidneys and liver should be working well enough to participate.

Who Cannot Join the Study?

Patients who have not been diagnosed with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)/AML, or Chronic Myelomonocytic Leukemia (CMML) cannot participate. These are specific types of blood cancers.
Individuals who do not fall within the specified age range for the study are excluded. The age range is not specified here, but it is important for eligibility.
Participants who do not meet the gender criteria, as both males and females are eligible, will be excluded.
Those who are not part of the vulnerable population selected for the study will be excluded. A vulnerable population may include groups like children, pregnant women, or others who need special protection in research.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Centre Hospitalier Universitaire De Nice	Nice	France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hhporfsd Uhvnswrhst Codzhyq Hroetpis	Helsinki	Finland
Ixvurrvr Pbuotsabrwfodsd Cjwvpn Cdxlop	Marseille	France

Trial status

Country	Status	Recruitment Start
Finland	Not recruiting	30.12.2024
France	Not recruiting	30.12.2024
Germany	Not recruiting	30.12.2024

Trial locations

Investigated drugs:

S227928 is an experimental medication being studied for its potential to treat certain types of blood cancers. It is an antibody-drug conjugate, which means it combines an antibody with a drug to specifically target and attack cancer cells. In this trial, it is being tested both on its own and in combination with another medication to see how well it works and how safe it is for patients with relapsed or refractory acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia.

Venetoclax is a medication used to treat certain types of blood cancers. It works by helping to kill cancer cells by blocking a protein that helps them survive. In this trial, venetoclax is being used in combination with S227928 to see if the combination is more effective in treating the cancers than using S227928 alone. The study aims to understand the safety and effectiveness of this combination therapy.

Investigated diseases:

Acute Myeloid Leukemia (AML) – A type of cancer that starts in the bone marrow, where blood cells are made, and quickly moves into the blood. It affects a group of white blood cells called myeloid cells, which normally develop into various types of mature blood cells. In AML, these cells do not mature properly and multiply uncontrollably, leading to a buildup of abnormal cells in the bone marrow and blood. This can interfere with the production of normal blood cells, causing symptoms like fatigue, infections, and easy bruising or bleeding. The disease can progress rapidly if not managed.

Myelodysplastic Syndromes (MDS) – A group of disorders caused by poorly formed or dysfunctional blood cells. These conditions occur when the blood-forming cells in the bone marrow are damaged, leading to a shortage of one or more types of blood cells. Symptoms may include fatigue, shortness of breath, and increased risk of bleeding or infection. MDS can sometimes progress to acute myeloid leukemia, a more aggressive form of blood cancer. The progression of MDS varies, with some cases remaining stable for years and others advancing more quickly.

Chronic Myelomonocytic Leukemia (CMML) – A type of cancer that starts in blood-forming cells of the bone marrow and invades the blood. It is characterized by an increase in monocytes, a type of white blood cell, and can lead to symptoms such as fatigue, fever, and weight loss. CMML is considered a type of myelodysplastic/myeloproliferative disease, meaning it has features of both myelodysplastic syndromes and myeloproliferative disorders. The disease can progress slowly or transform into acute myeloid leukemia over time.

Trial ID:

2024-514356-33-00

Protocol code:

S227928

NCT ID:

NCT06563804

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of S227928 Alone and with Venetoclax for Patients with Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia

What is this study about?

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Who Cannot Join the Study?