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Study of AZD2962 tablets alone and with other medications in patients with myelodysplastic syndromes and dysplastic chronic myelomonocytic leukemia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Myelodysplastic Syndromes and Dysplastic Chronic Myelomonocytic Leukemia, which are blood disorders affecting the production of blood cells in the bone marrow. The study will test a new medication called AZD2962, which is taken as a film-coated tablet by mouth. This drug works by blocking a protein called IRAK4 that may play a role in these blood disorders.

The main purpose of this research is to understand how safe the medication is and how well patients can tolerate it. The study will evaluate AZD2962 both when given alone and when combined with other treatments. Researchers will also determine the most effective dose of the medication that can be safely given to patients.

During the study, participants will take the medication and undergo regular check-ups to monitor their health. Doctors will track how patients respond to the treatment by examining their blood and bone marrow samples. The study will also measure how long the medication stays in the body and how it affects the blood disorder over time.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your eligibility for the study will be evaluated based on specific medical criteria.

    A bone marrow assessment or biopsy will be required before starting the treatment.

    Laboratory tests will check your blood cell counts and organ function, including liver and kidney tests.

  2. Step 2

    Treatment initiation

    You will receive AZD2962 in the form of film-coated tablets that you will take by mouth.

    The medication is designed to treat blood disorders including myelodysplastic syndromes or chronic myelomonocytic leukemia.

    Your doctor will determine the appropriate dose for your condition.

  3. Step 3

    Monitoring period

    Regular medical examinations will track your health status.

    Blood tests will be performed to monitor your response to treatment.

    Heart monitoring through ECG (electrical heart activity recording) will be conducted.

    Any side effects or reactions will be documented and assessed.

  4. Step 4

    Response assessment

    Your response to the treatment will be evaluated through regular medical check-ups.

    Blood tests will track changes in your condition.

    The effectiveness of the treatment will be measured by examining how your disease responds.

  5. Step 5

    Long-term follow-up

    Your health status will continue to be monitored throughout the study period.

    The study is expected to continue until February 2028.

    Regular assessments will track your long-term response to the treatment.

Who can join the trial?

6 criteria

  • Must be at least 18 years old when signing the consent form
  • Must have either: - Relapsed/refractory MDS (a bone marrow disorder where blood cells don't develop properly) or - Relapsed/refractory dysplastic CMML (a blood cell disorder), with less than 20% abnormal cells in blood or bone marrow - Must have received at least one previous treatment
  • Must have an ECOG performance status of 2 or better (able to perform most daily activities with some limitations)
  • Must have symptoms that require treatment and can be measured to assess if therapy is working
  • Must be willing to provide a bone marrow sample before starting treatment
  • Must meet specific blood test requirements: - White blood cell count must be 10.0 x 109/L or less for MDS patients, or less than 13.0 x 109/L for CMML patients - Liver function tests (ALT and AST) must be no more than 3 times the normal limit - Bilirubin level must be no more than 1.5 times the normal limit (3 times if you have Gilbert's Syndrome) - Kidney function must show creatinine clearance of 60 mL/min or better

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Pregnant or breastfeeding women
  • History of severe allergic reactions to medications
  • Active infections or ongoing serious illness
  • Participation in other clinical trials within the past 30 days
  • Severe heart, liver, or kidney problems
  • Previous treatment with similar medications in the past 6 months
  • Mental conditions that could affect the ability to provide informed consent
  • Abnormal blood test results that suggest poor organ function
  • History of other types of cancer in the past 5 years
  • Unable to follow study procedures or attend regular visits
  • Taking medications that could interact with the study drug
  • Uncontrolled high blood pressure or diabetes
  • Bone marrow transplant in the past 2 years
  • Life expectancy less than 3 months
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Investigated drugs

AZD2962 is an IRAK4 inhibitor medication being studied for treating blood-related cancers (hematologic neoplasms). This medication works by blocking a specific protein called IRAK4, which plays a role in cell signaling pathways that can contribute to cancer growth. The medication is being tested both on its own (monotherapy) and in combination with other cancer treatments to evaluate how safe it is and how well it works in patients with blood cancers.

What is already known about the treatment

AZD2962 - An IRAK4 inhibitor medication currently being investigated in clinical trials for the treatment of hematologic neoplasms, particularly myelodysplastic syndromes and dysplastic chronic myelomonocytic leukemia. The drug works by inhibiting IRAK4 (Interleukin-1 Receptor-Associated Kinase 4), a key enzyme involved in inflammatory signaling pathways important in blood cell disorders. Currently in Phase I/II clinical trials, this experimental therapy is being evaluated both as a standalone treatment and in combination with other agents, with primary goals of establishing its safety profile and determining the optimal biological dose for treatment. The medication represents a novel therapeutic approach in hematologic oncology, though its final approval status and full efficacy profile are still being determined through ongoing clinical research.

Investigated diseases

  • Dysplastic chronic myelomonocytic leukemia

    A blood cell disorder that affects bone marrow function and blood cell production. The condition causes abnormal white blood cells called monocytes to build up in the blood and bone marrow. It combines features of two blood disorders: myelodysplastic syndrome and myeloproliferative disorder. The disease typically develops slowly over time, leading to decreased production of normal blood cells.

  • Myelodysplastic syndromes

    A group of blood disorders where the bone marrow doesn't produce enough healthy blood cells. In this condition, immature blood cells fail to develop normally and die in the bone marrow or blood. This leads to low levels of one or more types of blood cells. The condition causes the bone marrow to make blood cells that are both defective and poorly formed.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2025-520786-44-00Protocol codeD7770C00001Estimated enrolment77 patientsSponsorAstraZeneca AB

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).