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Looking for participantsPhase1

A Study of AZD2962, an IRAK4 Inhibitor (IRAK4 [a Body Protein] Blocker), in Participants With Haematologic Neoplasms (Blood Cancers)

Sponsor: AstraZeneca

NCT ID: NCT07064122

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AZD2962 (drug)
How long the study runs
Study runs about 35 months (dates as stated)
About the drug or intervention
AZD2962 — drug: AZD2962 will be administered orally once daily.
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a drug called AZD2962 in people with blood cancers. AZD2962 blocks a protein in the body called IRAK4, which is involved in inflammation. The study is for people whose disease has come back or has not responded to treatment.

Who can take part

  • People with relapsed or refractory myelodysplastic syndromes (MDS), or a type of leukaemia called dysplastic CMML, with fewer than 20% blast cells in the blood or bone marrow, who have had at least one previous treatment or have run out of available options
  • Diagnosis confirmed using the WHO 2016 classification of myeloid neoplasms
  • Fairly well in terms of daily activity (ECOG performance status of 2 or less)
  • Disease is causing symptoms and needs treatment that can be measured
  • Willing to give a bone marrow sample at the start
  • Using contraception as required by the study rules and local regulations
  • Women who could become pregnant must have a negative pregnancy test at screening

Who may not be able to

  • Previous treatment with IRAK inhibitors or drugs that block the inflammasome pathway
  • Any cancer treatment (except hydroxyurea) in the 15 days before the first dose
  • Strong or moderate CYP3A inhibitor medicines in the 15 days before the first dose
  • Major surgery in the 28 days before the first dose, or still recovering from surgery
  • Drugs known to prolong the QT interval of the heart (with a known risk of a dangerous heart rhythm problem) in the 15 days before the first dose
  • Immunosuppressive medicines (including graft-versus-host disease prevention) in the 28 days before the first dose, or steroid tablets above 10 mg prednisone a day in the 15 days before
  • Live vaccines in the 28 days before the first dose
  • Currently having a major bleeding event
  • Any other illness or test result that would make taking part unsafe or unsuitable
  • A long QT interval on heart tests (over 450 ms, or over 470 ms with bundle branch block)
  • Bleeding in the brain in the 6 months before the first dose
  • Active gut disease or other condition that would affect how the body handles the oral treatment
  • A previous non-blood cancer (with some exceptions)
  • Ongoing side effects from earlier cancer treatment worse than grade 2 (with some exceptions)
  • Taking part in another clinical study at the same time (with some exceptions)
  • Known allergic reaction to the study drug or its ingredients

What taking part involves

  • • Taking an oral (by mouth) study drug called AZD2962, which blocks a body protein called IRAK4
  • • Providing a bone marrow sample at the start of the study

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 110 Years
Who
All
Number of participants
72
Started
2025-11-03
Last checked
2026-02

Plain English Summary

What is this study?

  • • Testing a new treatment for haematologic neoplasms
  • • Phase1 - 72 participants
  • • The purpose of the study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of AZD2962, an Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) inhibitor, as monotherapy and in combination with other agents in participants with haematologic neoplasms

Who can take part?

  • • Ages 18 Years to 110 Years
  • • Diagnosed with haematologic neoplasms

Where?

  • • London - Research Site
  • • London - Research Site
  • • Manchester - Research Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of the study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of AZD2962, an Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) inhibitor, as monotherapy and in combination with other agents in participants with haematologic neoplasms.

More detail

This is a modular study. In Module 1, the study will begin with a dose escalation of AZD2962 monotherapy in participants with myelodysplastic syndromes (MDS) and dysplastic chronic myelomonocytic leukemia (CMML). Module 1 of the study will comprise of: 1. A Screening Period of maximum 21 days. 2. Treatment period with 28-day cycles where each patient will receive an oral dose of AZD2962 once daily, starting on Day 1, and will continue treatment until disease progression, unacceptable toxicity, or withdrawal. 3. Safety Follow-up period after 30 days after last dose.

Haematologic Neoplasms

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 110 Years
  • Who can join: All genders

Biomarkers mentioned

have a negative

Treatment history

Treatments you must have had:

  • ✓ symptomatic disease that requires therapy and allows for objective efficacy assessments
  • ✓ a negative serum pregnancy test result at Screening

What the study is looking for

  • ✓activity scale (ECOG) performance status of ≤2.
  • ✓Participants must have causing symptoms disease that requires therapy and allows for objective efficacy assessments.
  • ✓Willing to provide baseline bone marrow aspirate (or biopsy if dry-tap).
  • ✓Contraceptive use by participants or participant partners should be consistent with local regulations and also...
  • ✓All women of childbearing potential must have a negative serum pregnancy test result at Screening.

Who cannot take part

  • ✗Prior treatment with IRAK inhibitors or inhibitors of the inflammasome pathway.
  • ✗Received any antineoplastic therapy (except hydroxyurea) within 15 days prior to first dose.
  • ✗Received any strong or moderate Cytochrome P450 3A (CYP3A) inhibitors within 15 days prior to first dose.
  • ✗Received major surgery within 28 days prior to first dose, or still recovering from surgery.
  • ✗Received drugs that are known to prolong corrected QT interval (QTc) and with known risk of Torsades de Pointes,...
See the full criteria
Key Inclusion Criteria: 1. Participants with relapsed/refractory MDS or participants with relapsed/refractory dysplastic CMML, with peripheral blasts or bone marrow blasts \< 20%, and who received one or more prior lines of therapy as per standard of care (or who exhausted locally available treatments including treatments for actionable mutations). Diagnosis must be histologically confirmed as per the WHO 2016 classification of myeloid neoplasms. 2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2. 3. Participants must have symptomatic disease that requires therapy and allows for objective efficacy assessments. 4. Willing to provide baseline bone marrow aspirate (or biopsy if dry-tap). 5. Contraceptive use by participants or participant partners should be consistent with local regulations and also comply with Clinical Study Protocol requirements. 6. All women of childbearing potential must have a negative serum pregnancy test result at Screening. Key Exclusion Criteria: 1. Prior treatment with IRAK inhibitors or inhibitors of the inflammasome pathway. 2. Received any antineoplastic therapy (except hydroxyurea) within 15 days prior to first dose. 3. Received any strong or moderate Cytochrome P450 3A (CYP3A) inhibitors within 15 days prior to first dose. 4. Received major surgery within 28 days prior to first dose, or still recovering from surgery. 5. Received drugs that are known to prolong corrected QT interval (QTc) and with known risk of Torsades de Pointes, within 15 days prior to first dose. 6. Received immunosuppressive medications (including Graft-Versus-Host Disease prophylaxis) within 28 days prior to first dose, or within 15 days in the case of systemic steroids (doses exceeding 10 mg/day of prednisone or equivalent). 7. Received live attenuated vaccines within 28 days prior to first dose. 8. Active major bleeding event. 9. Any evidence of systemic disease, significant clinical disorder, or laboratory finding that make undesirable the participation in the study. 15\. Mean resting corrected QT interval using Fridericia's formula (QTcF) \> 450 ms obtained from triplicate Electrocardiograms (ECGs) and averaged, recorded within 5 minutes. In the presence of bundle branch block, QTcF \> 470 ms is applicable. 16\. History of intracranial bleeding within 6 months prior to first dose. 17. Active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism or excretion of oral therapy. 18\. History of a prior non-haematologic neoplasm (with some exceptions). 19. Unresolved Grade \> 2 toxicities from prior anticancer therapies (with some exceptions). 20\. Concurrent enrolment in another clinical study (with some exceptions). 21. Known hypersensitivity to study intervention or its excipients.

Where Is This Study? (3 UK sites)

Research Site

London SE5 9RS, United Kingdom

Recruiting

Research Site

London W1T 7HA, United Kingdom

Recruiting

Research Site

Manchester M20 4BX, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-02